Study characteristics

Methods

Quasi‐randomised trial: by alternation; participants were allocated "sight unseen"

Participants

Caulfield Hospital, Victoria, Australia
Period of study: started 12 May 1985
40 participants
Inclusion: women with a hip fracture
Exclusion: rheumatoid arthritis, active cardiac disease, neurological condition that would influence gait pattern
Age: mean 83.5 years (range 69 to 97 years)
% male: none
Number lost to follow‐up: probably none, although 1 died.

Interventions

Early postoperative rehabilitation
1. Treadmill gait retraining programme. Use of Repco treadmill with velocity and distance controls. Adjustable side rails for partial weight‐bearing stage.
versus
2. Conventional gait retraining involving use of ambulatory aid (walking frame)

Both groups had participated in the same muscle strengthening programme beforehand. Other aspects of physical therapy was reported to be similar.

Outcomes

Length of follow‐up: until discharge from rehabilitation hospital

Mobility level at discharge (3 levels: house bound; limited outdoor activity; outdoor activity unlimited by symptoms)
Walking velocity

Knee extensor strength
Return to living at home
Length of hospital stay
Mortality (in hospital)

Notes

A subgroup of 6 'matched pairs' were studied in greater detail for gait analysis, strength and length of stay. These matched pairs are not included in this review.

Funding: none declared

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Quasi‐randomised trial involving alternation: "the first patient was allocated to the treadmill group, the second to the control group, and so on".

Allocation concealment (selection bias)

High risk

Predictable sequence even though researcher apparently "allocated patient 'sight unseen'"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No mention of blinding of therapists conducting the intervention and the participants. Impact of non‐blinding is unclear.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

High risk

There was no mention of blinding.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

Not blinded; however, the assessment of the outcome is unlikely to be influenced by knowledge of group allocation

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

High risk

Measure of mobility assessment was crude. Gait analysis was reported for 6 matched pairs: this decision was not explained fully.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

High risk

The group allocations for the only death and the 5 other participants requiring nursing home or special accommodation were not given.

Selective reporting (reporting bias)

High risk

The reason for reporting gait analysis outcomes for 6 matched pairs was not provided.

Free from baseline imbalance bias?

Unclear risk

Insufficient information

Free from performance bias due to non‐trial interventions?

Low risk

Explicit mention of comparability

Study characteristics

Methods

Randomised trial: use of a computer‐generated algorithm and block design, stratified by type of surgery (hemiarthroplasty or internal fixation)

Participants

Community‐dwellers, St Louis, Missouri, USA
Period of study: August 1998 to May 2003
90 participants
Inclusion: physically frail people (modified Physical Performance Test score of 12 to 28 and ADL difficulty) aged 65 years or over with a surgically‐repaired proximal femoral fracture in the previous 16 weeks who had completed standard physical therapy. Informed consent
Exclusion: pathological fracture, contralateral hip fracture, dementia or cognitive impairment, inability to walk 50 feet, visual or hearing impairments interfering with participation, other major medical conditions (cardiopulmonary or neuromuscular disease), taking medication for osteoporosis, on hormone replacement therapy, terminally ill
Age: mean 80 years (range not given)
% male: 26
Number lost to follow‐up: 5 (2 due to personal reasons, 2 due to medical problems, 1 died)

Interventions

Started after end of standard physical therapy.
1. Six months of supervised exercise carried out 3 times weekly. For the first 3 months, small group (2 to 5 participants) progressive exercise for flexibility, balance, co‐ordination, movement speed, strength and endurance led by a physical therapist. After the first 3 months, progressive resistance training was added (progressed by end of 1 month to 3 sets of 8 to 12 repetitions at 85% to 100% of initial 1 RM voluntary strength.
versus
2. Low‐intensity, non‐progressive home exercise programme carried out 3 times weekly after a 1‐hour training session, plus monthly group sessions and weekly 10‐minute telephone calls.

Additional interventions for both groups: monitoring and instruction by dietitian if indicated, and vitamin D if indicated at baseline. All received calcium and multi‐vitamin tablets.

Outcomes

Length of follow‐up: 6 months

Physical Performance Test score (modified)
Functional Status Questionnaire score
Instrumental Activities of Daily Living score
Basic Activities of Daily Living score
Use of assistive gait devices
Knee extension strength
Fast walking speed
Single limb stance time
Berg Balance Scale
SF‐36 (health, physical function, social subscales)
Hip Rating Questionnaire
Adherence
Adverse events and subsequent fractures
Mortality

Notes

Host 2007 reported data only from intervention group participants (31/46 participants) who had completed at least 30 sessions in each of the two 3‐month exercise phases.

Measured adherence

Funding: National Institute of Aging grant R01 G15795, the Washington University General Clinical Research Center grant 5‐M01 RR00036, the Washington University Clinical Nutrition Research Center grant P30 DK56341, and the Barnes Jewish Hospital Foundation.

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Random assignment ... was performed on completion of the baseline assessments within strata, defined as the types of surgical repair procedure (hemiarthroplasty vs open reduction internal fixation), using a computer generated algorithm and block design."

Allocation concealment (selection bias)

Unclear risk

No clear indication of allocation concealment

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

There was blinding of outcome assessors: "the research staff who conducted the assessments were not involved in exercise training and were blinded to group assignment".

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Unclear risk

Binding relating to attribution of study related/unrelated causes of medical problems or fractures is uncertain.

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

Unclear risk

There was blinding of outcome assessors: "the research staff who conducted the assessments were not involved in exercise training and were blinded to group assignment".

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Unclear risk

Five of the 90 participants were lost to follow‐up at 6 months. The last observation for these 5 participants was carried forward and an intention‐to‐treat analysis was conducted with data for the whole trial population.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Low risk

Mortality follow‐up adequate

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

Unclear risk

Five of the 90 participants were lost to follow‐up at 6 months. The last observation for these 5 participants was carried forward and an intention‐to‐treat analysis was conducted with data for the whole trial population.

Selective reporting (reporting bias)

Low risk

Pre‐trial completion information shows consistent primary outcome

Free from baseline imbalance bias?

Low risk

Comprehensive breakdown of characteristics without significant differences

Free from performance bias due to non‐trial interventions?

Low risk

Measures taken to counteract differences in social contact in the control group by weekly phone calls

Study characteristics

Methods

Randomised trial: 2x2 factorial design

Participants

Triemli City Hospital, Switzerland
Period of study: January 2005 to December 2007
173 participants
Inclusion: aged 65 years or over with a surgically‐repaired hip fracture, MMSE ≥ 15, able to walk 3 m, German speaking, creatinine clearance of more than 15 mL/min (to convert to millilitres per second, multiply by 0.0167)
Exclusion: prior fracture of same hip, metastatic cancer or chemotherapy in the last year, severe visual or hearing impairment, kidney stone in the past 5 years, hypercalcaemia, primary hyperparathyroidism or sarcoidosis

Age: mean 84 years (range 65 to 99)
% male: 21
Number lost to follow‐up: 22. Analysed as ITT

Interventions

Extended physiotherapy plus high/low dose cholecalciferol

1. Extended physiotherapy plus 800 IU/d cholecalciferol. Supervised 60 min during acute care (additional 30 min home programme instruction each day during acute care) plus unsupervised home programme over 12 months. Advised to maintain usual diet and avoid additional calcium and cholecalciferol supplements.

2. Standard physiotherapy (supervised 30 min/day during acute care plus no home programme) plus 2000 IU/d cholecalciferol

3. Extended physiotherapy plus 2000 IU/d cholecalciferol.

4. Control. Standard physiotherapy (supervised 30 min/day during acute care plus no home program) plus 800 IU/d cholecalciferol. Advised to maintain usual diet and avoid additional calcium and cholecalciferol supplements.

Only the comparison of standard versus extended physiotherapy eligible for inclusion in this review.

Outcomes

Length of follow‐up: 24 weeks

Mortality

Knee extensor

Timed Up & Go

EQ‐5D‐3L

Adverse effects: re‐fracture rate, re‐admission, admission to institution, falls, mild hypercalcaemia, nephrolithiasis

Adherence (total days and minutes of physiotherapy)

Notes

Measured adherence

Funding: this study was supported by Swiss National Foundations (NFP‐53), Vontobel Foundation, Baugarten Foundation and Swiss National Foundations professorship grant PP00B‐ 114864.

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐based randomisation

Allocation concealment (selection bias)

Unclear risk

Not clearly reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

Outcome assessors blinded

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

Outcome assessors blinded. All admission records were reviewed by 3 blinded co‐investigators to determine the main cause of re‐admission.

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

Unclear risk

Outcome assessors blinded for health‐related quality of life. Blinding of personnel collecting fall data and answering hotline telephones was not specified.

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

High risk

Large degree of loss to follow‐up. Although analysed as ITT, the high degree of attrition incurs a high risk of bias.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

High risk

Large loss to follow‐up

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

High risk

Large loss to follow‐up

Selective reporting (reporting bias)

Unclear risk

Mobility outcomes not clearly stated in study registration

Free from baseline imbalance bias?

Low risk

Groups balanced at baseline

Free from performance bias due to non‐trial interventions?

High risk

Extended physiotherapy had home visits which may have a confounding effect due to the social interaction

Method of ascertaining falls

Low risk

Falls recorded via monthly telephone calls and a patient diary. Also, a telephone hotline to report falls at any time

Study characteristics

Methods

Randomised controlled trial

Participants

Two rehabilitation units at two hospitals (Glasgow Royal Infirmary and Hairmyres Hospital), UK
Period of study: November 1999 to November 2000
26 participants
Inclusion: people aged ≥ 65 years with hip fracture treated surgically (all internal fixation) up to 21 days previously, written informed consent
Exclusion: terminal disease, abbreviated mental score < 7/10, previous inability to walk, profoundly deaf, cardiac pacemaker, unstable medical conditions (e.g. pneumonia, heart failure)
Age: mean 81 years (range not stated)
% male: 8%
Number lost to follow‐up: 3 refusals + 2 deaths; also 2 telephone follow‐up only

Interventions

Postoperative rehabilitation

1. Supplementary electrical stimulation (ES) of quadriceps for 6 weeks: 5 days / week for inpatients; twice a week upon discharge. ES consisted of 7 seconds of stimulation of quadriceps followed by 23 seconds of relaxation for 36 repetitions; each session lasted 18 minutes. Delivery by physiotherapist assistant. Usual physiotherapy.
versus
2. Usual physiotherapy only. Inpatient physiotherapy consisted of supervised strengthening and range of motion exercises, balance training, work on transfers and progressive gait re‐education.

Expert physiotherapist established optimum electrical stimulation post‐baseline measurement but prior to randomisation (tolerance levels not provided for control group participants).

Intervention started in hospital, baseline measurements at median 10 to 11 days post‐surgery, and continued at home after hospital discharge.

Outcomes

Length of follow‐up: 14 weeks

Elderly Mobility Scale
Leg extension power
Barthel Index
Nottingham Health Profile (gait speed, emotional reactions, energy, pain, physical mobility, sleep, social isolation)
Mortality

Notes

Two other outcomes (Timed Up and Go test, isometric quadriceps strength) described in trial registration / abstracts but not in full report

Funding: Royal Infirmary Reserch Endowments Fund

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Randomisation was by computer‐generated random numbers"

Allocation concealment (selection bias)

Low risk

"[With] individual patient codes held in opaque sealed envelopes by an administrator independent from the study.”

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

“Measurements were made at baseline, at 6 weeks (the end of intervention) and 14 weeks by a single blinded assessor.”

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

Only mortality was reported. “Measurements were made at baseline, at 6 weeks (the end of intervention) and 14 weeks by a single blinded assessor.” Assessment of mortality is not likely to be influenced by knowledge of group allocation.

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Unclear risk

Although participant flow data provided, loss to follow‐up was proportionality greater in the intervention group.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Low risk

Only mortality reported

Selective reporting (reporting bias)

Unclear risk

Consistent reporting of primary outcomes, but 'Timed Up and Go test' and isometric muscle data indicated in abstract and trial registration form are missing

Free from baseline imbalance bias?

Unclear risk

"There was a non‐significant trend for the control group to have a greater unfractured leg extensor power and higher Barthel scores at study entry." Proportionally fewer intervention group participants had independent mobility at baseline (27% versus 55%).

Free from performance bias due to non‐trial interventions?

Unclear risk

Although participants in both groups received standard physiotherapy while inpatients, it is not clear whether post‐discharge provision was similar.

Study characteristics

Methods

Randomised controlled trial

Participants

Moscow City Hospital NO71, Moscow, Russia
Period of study: February to November 2005
60 participants
Inclusion: people aged between 60 and 75 years who had undergone stabilisation (dynamic hip screw or external fixation) of an A2 femoral trochanteric fracture. Informed consent
Exclusion: limitations that might interfere with electrical stimulation including insulin pumps, pacemakers and neurostimulation implants; history of epilepsy or seizure; bilateral fractures; pathological fractures (excluding osteoporosis)
Age: mean 71 years (range 63 to 75)
% male: 33%
Number lost to follow‐up: 0

Interventions

Postoperative rehabilitation. Electrical stimulation or placebo (sham device) included in the standard rehabilitation started within 24 hours of surgery. Treatments and physiotherapy were carried out each morning and took 20 to 30 minutes to complete. Non‐steroidal anti‐inflammatory drug (ketorolac tromethamine) prescribed as needed.

1. Electrical stimulation (ES) for 10 days: use of a hand‐held, non‐invasive, interactive neurostimulation device (InterX 5000; Neuro Resource Group, Plano, Texas). (Device generates high peak amplitude averaging 17 volts on the skin with a low current of about 6 milliamperes (mA), and damped biphasic electrical impulses which are delivered to the tissue via a pair of concentric electrodes placed in direct contact with the target area. Device adjusts biphasic stimulus in accordance to the impedance of the underlying tissue by varying voltage to maintain constant peak current. Device applied for 20 to 30 minutes with electrodes at 3 sites close to surgical incision. Also corresponding areas on contralateral side. After adjustment for impedance, intensity increased to produce "comfortable sensation for patient").
versus
2. Sham device; same timing.

All the participants received standard interdisciplinary postoperative care including routine assessment and daily care by an orthopaedic surgeon supported by a physiotherapist and nurse.

Outcomes

Length of follow‐up: 10 days (end of treatment)

Pain score (VAS: 0 to 10: worst)
'Pain inventory': effects of pain on walking ability, sleep, mood and enjoyment of life (1: no interference; 10: absolute interference)
Analgaesic consumption
Surgeon's evaluation of participant's progress at 10 days in terms of improvement: none, minimal, average, substantial, full recovery

Notes

All participants were functionally independent before start of study.
Authors refer to reduced life expectancy in Russia.

Funding / conflict of interest: "The author or one or more of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article. In addition, benefits have been or will be directed to a research fund, foundation, educational institution, or other nonprofit organisation with which one or more of the authors are associated".

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information. "Fixed randomisation scheme with sealed envelopes"

Allocation concealment (selection bias)

Unclear risk

"Fixed randomisation scheme with sealed envelopes"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

"The therapist who administered treatment was aware of the assignment of the patient to an active or sham device. However, all the assessing surgeons, patients and research personnel involved in determining and recording outcome measurements were blinded to this information. The sham device had an identical appearance and application to the active device with lights, buzzing and beeps, but did not produce interactive neurostimulation." Patient blinding may not be possible if they are familiar with neurostimulation.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

All the assessing surgeons, patients and research personnel involved in determining and recording outcome measurements were blinded to this information (active v sham device).

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

Assessment of the outcome is not likely to be influenced by knowledge of group allocation.

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Low risk

No loss to follow‐up

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Unclear risk

Not reported

Selective reporting (reporting bias)

Unclear risk

Possible but no trial protocol or trial registration available

Free from baseline imbalance bias?

Low risk

Intervention groups appeared well matched.

Free from performance bias due to non‐trial interventions?

Low risk

Same rehabilitation provided to all

Study characteristics

Methods

Randomised trial: method not stated; stratified by age of participant

Participants

Western Infirmary, Glasgow, UK
Period of study: February 1961 to August 1966
273 participants (but possible that 604 participants were randomised)
Inclusion: people with a displaced intracapsular proximal femoral fracture (Garden type III or IV) treated by closed reduction and internal fixation with a sliding nail plate.
Exclusion (post randomisation): any reason (pulmonary or cardiac complications, deep venous thrombosis, general feebleness, re‐displacement of the fracture) at 2 weeks that the individual was not considered fit enough to walk at this time.
Age: not stated (within 56 to 95 for the 175 participants followed up for 3 years)
% male: not known
Number lost to follow‐up: disregarding post‐randomisation exclusions, 13 with incomplete follow‐up and 43 died at 1 year.

Interventions

Early postoperative rehabilitation. Operative treatment consisted of closed fracture reduction and internal fixation with a sliding nail plate. For the first 2 weeks postop, patients sat out of bed but were not permitted to stand or walk.
1. Early weight bearing at 2 weeks after surgery: unguarded walking
versus
2. Delayed weight bearing until 12 weeks after surgery

Outcomes

Length of follow‐up: 1 year for all, 3 years for subgroup

Mortality
Non‐union of the fracture (failure)
Avascular necrosis (segmental collapse)
Infection of the hip

Notes

An interim report for 124 trial participants at 3 months was available in 1964 (Abrami 1964), with a second report in 1968 (Graham 1968) which presented results for 273 participants at 1 year and results at 3 years for the 175 participants who had been followed up by then. Data from Abrami 1964 are not presented in the review.

Funding: none declared

Conflict of interest: none declared

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

According to earliest report: "After operation, but according to the sequence of their admission to hospital, patients in comparable five‐year age groups were randomly allocated to either the early or the late weight‐bearing groups" (Abrami 1964). But as reported by Graham 1968: "After admission to hospital each patient was allocated, by random selection, to an early or late weight‐bearing group within each decade from fifty‐six to ninety‐five years'. It was emphasised in the report that it was not alternation.

Allocation concealment (selection bias)

Unclear risk

No information

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No mention of blinding. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

High risk

No mention of blinding, nor of measures taken to safeguard knowledge of allocation at follow‐up data collection

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Unclear risk

No mention of blinding; however, assessment of the outcome is unlikely to be influenced by knowledge of group allocation

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

High risk

Outcomes were not reported. Even so, there was incomplete long‐term follow‐up (only 175 of the 273 included participants ‐ after post‐randomisation exclusions) ‐ see next item.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

High risk

Trial recruitment and randomisation were at hospital admission (604 admitted), but only those 273 patients who were judged as being suitable ‐ in that they could be expected to walk at the 2‐week clinical assessment ‐ were included in the analyses. The number of participants excluded at 2 weeks was not reported. Included participants were analysed in the group they were allocated at randomisation.

Selective reporting (reporting bias)

High risk

No indication of a protocol. Interim results generally reported. Differences between papers in account of trial (e.g. stratification)

Free from baseline imbalance bias?

High risk

Baseline data not given for randomised groups, nor for followed‐up participants, with the exception of gender and age group. All intracapsular fractures treated with same implant

Free from performance bias due to non‐trial interventions?

High risk

No information

Study characteristics

Methods

Randomised controlled trial using a protected random number system; stratified by hip‐ or lower‐extremity fracture surgery and non‐hip‐ or lower‐extremity fracture patients (see Notes)

Participants

Heidelberg, Germany
Period of study: not stated, but trial may have started around 1997
28 female participants
Inclusion: females aged ≥ 75 years (25 with a fall‐related hip fracture and 3 with elective hip surgery) who had experienced a recent injurious fall. Written informed consent and permission from orthopaedic surgeon
Exclusion: acute neurological impairment, severe cardiovascular disease, unstable chronic or terminal illness, major depression, severe cognitive impairment, severe musculoskeletal impairment
Age: mean 81 years (range not stated)
% male: none
Number lost to follow‐up: 4 (3 didn't start exercises and 1 dropped out)

Interventions

Started immediately upon hospital discharge.
1. 12‐week regimen of intensive physical training (lower extremity progressive resistance training, progressive functional and balance training). All exercise sessions took place in training groups (4 to 6 participants) supervised by a therapeutic recreation specialist. Each session: 1.5 hours of resistance training (with recovery breaks) and 45 minutes of balance/functional training. Intensity of strength training adjusted to 70% to 90% of individual maximal workload. Basic functions such as walking, stepping or balancing were trained progressively with increasing complexity.
versus
2. Placebo motor activity: 1‐hour sessions of activities such as flexibility exercise, callisthenics, ball games and memory tasks while seated.

Both regimens, taking place 3 times a week, started on average 4 to 5 weeks after surgery upon discharge from inpatient rehabilitation. Both groups received identical additional physiotherapy (mainly massage, stretching and application of heat or ice) twice weekly for 25 minutes: strength and balance training was excluded from these sessions.

Outcomes

Length of follow‐up: 6 months (12 weeks + 3 months)

Walking velocity and cadence
Independent weight bearing
Performance‐orientated motor assessment
Box step
Functional Reach
Timed Up and Go test
Chair and stair rises
Activities of daily living; sports and household activities
Muscle strength: leg‐press, leg‐extensor, leg flexor, ankle‐plantar flexion, hand grip strength (non‐trained muscle group)
Loss of independence
Subjective fear of falling
Subjective walking steadiness
Emotional state: depression, morale and handicap scales
Adherence

Notes

Measured adherence

This trial was excluded from versions of this review up to Issue 3, 2004 because the intervention began after the early postoperative period covered by this review, which then focused on early postoperative rehabilitation.

Trial actually included 57 people who had experienced an injurious fall. One report of the trial gave the results for the subgroup of 28 participants who had hip surgery. Of these, 25 had surgery for a fall‐related hip fracture and 3 had elective hip surgery. The patient characteristics of the latter 3 women were confirmed as being essentially similar to those of the 25 women with hip fracture. A 2‐year follow‐up of the trial is available but only for the whole trial population.

Further information, including method of randomisation, received from lead trialist on 05 March 2004 and 24 June 2004

Funding: grant from Ministerium fur Wissenschaft, Forschung und Kunst Baden‐Wuerttemberg and the University of Heidelberg

Conflict of interest: none declared

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Randomization was performed .... using a protected random number system"

Allocation concealment (selection bias)

Low risk

"Randomization was performed by an external person who did not participate in the study using a protected random number system"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Care providers providing the intervention and the participants were not blinded to the group assignment. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

"Main outcome variables were documented by a person blinded to the patients' group assignment."

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

Unclear risk

"Main outcome variables were documented by a person blinded to the patients' group assignment."

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

High risk

Efforts had been made to collect outcome data for the 4 dropouts, 3 of whom did not start the exercises and 1 who discontinued their exercises. However, these data were not available.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Unclear risk

While all participants were accounted for, there were incomplete data on complications (although: 'minor') and long‐term follow‐up.

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

High risk

Efforts had been made to collect outcome data for the 4 dropouts, 3 of whom did not start the exercises and 1 who discontinued their exercises. However, these data were not available.

Selective reporting (reporting bias)

Unclear risk

Unclear. However, the 3 main reports of the trial were consistent in the reported outcomes and the author provided clarification on some of the outcome measures used.

Free from baseline imbalance bias?

Low risk

Baseline characteristics were similar in the 2 groups.

Free from performance bias due to non‐trial interventions?

Low risk

There was no cause for concern.

Study characteristics

Methods

Randomised trial: use of random numbers

Participants

University Central Hospital, Helsinki, Finland
Period of study: May 1973 to October 1974
100 participants
Inclusion: people aged > 50 years with femoral neck fracture treated surgically (internal fixation or prosthesis), capable of independent 'getting about' before fracture
Exclusion: none given
Age: mean 73 years (range not stated; all over 50 years)
% male: 25%
Number lost to follow‐up: 13 (excluded from 9‐week follow‐up because of inadequate follow‐up), 4 (excluded from 3‐month mortality data)

Interventions

Early postoperative rehabilitation, started first postoperative day onwards
1. Intensive (performed twice daily) physiotherapy regimen
versus
2. Same regimen performed once daily (conventional care)

Routine physiotherapy was on average 30 minutes per day. For the intensive group, the physiotherapy time was doubled. Both groups were under supervision of the study physiotherapist. Regimen was continued for 14 days. From first postoperative day, training in walking on crutches; training in sitting in chair; flexion‐extension movements of knee, hip and ankle. Most participants were allowed full weight bearing from the beginning. (For those with internal fixation, crutch use for up to 2 to 3 months.) From second postoperative week, training in walking up and down stairs.

Outcomes

Length of follow‐up: 9 weeks (for strength)

Walking ability
Ability to move and sit up in bed on first postoperative day
Abductor muscle strength at 9 weeks
Residence at 9 weeks
Mortality
"Mechanical" postoperative complications
Medical complications, including thromboembolism and postoperative infection
Length of hospital stay

Notes

Of the 100 people recruited for the trial, 13 had inadequate follow‐up and the results of these participants are not presented.

Most of the results for the trial were presented split according to whether the participant had a prosthesis or internal fixation, rather than by the trial interventions.

A thesis (1978, University of Helsinki) was located by Lesley Gillespie (10 June 2004). Requests for a copy met with no success.

Funding: none declared

Conflict of interest: none declared

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Using random numbers the patients selected for the study were divided before the operation into two physiotherapy groups."

Allocation concealment (selection bias)

Unclear risk

No report

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No mention of blinding. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

High risk

No mention of blinding

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Unclear risk

No mention of blinding; however, assessment of the outcome is unlikely to be influenced by knowledge of group allocation.

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

High risk

Results for 13 participants with inadequate follow‐up were not presented.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

High risk

Results for 13 participants with inadequate follow‐up were not presented.

Selective reporting (reporting bias)

High risk

Mobility data split by treatment group were not presented.

Free from baseline imbalance bias?

High risk

There was a lack of information on baseline characteristics and comparability; data were not provided for 13 participants with inadequate follow‐up. The report referred to a non‐significantly greater number of participants in the routine physiotherapy group being treated with Jewett nails.

Free from performance bias due to non‐trial interventions?

Low risk

Appears so; the same physiotherapist provided both interventions.

Study characteristics

Methods

Randomised controlled trial. Randomly assigned by computer program

Participants

The Alfred Hospital, a level 1 trauma centre, Melbourne, Australia
Period of study: March 2014 to January 2015
92 participants
Inclusion: at least 65 years old, admitted with an isolated subcapital or intertrochanteric hip fracture, treated by internal fixation or hemiarthroplasty
Exclusion: subtrochanteric or pathological fracture; postoperative orders for non‐weight bearing on the operated hip; unable to move independently or needed a gait aid prior to admission; admitted from nursing home
Age: mean (SD) = 81.3 (8.2)
% male: 36
Number lost to follow‐up: 13 (died = 1, unable to contact via telephone at 6 months = 12)

Interventions

1. Intervention group: usual care* in the morning plus 2 additional daily sessions, 7 days per week. One session (delivered by allied health assistant) practised the achievements of the morning session. One session (delivered by physiotherapist) aimed to improve the functional advances achieved during the earlier physiotherapy session; e.g. increased independence, progression of gait aid (e.g. from frame to crutches) and increasing the distance walked.

2. Control: usual care* in the morning

*Usual care: participants in both groups received daily physiotherapy according to usual practice in the trauma centre, 7 days per week. Treatment was individualised and involved bed‐based limb exercises (e.g. strength exercises, such as knee extension, and active hip exercises) and gait re‐training. The goal was early, independent transfer and mobility, with the objective of discharge directly home or to fast stream rehabilitation.

Outcomes

Length of follow‐up: Mobility and Modified Iowa Level of Assistance outcomes = Day 5 postop (or discharge, if discharged before Day 5); QOL 6 months.

Modified Iowa Level of Assistance score (hip‐fracture‐specific outcome, with 6 domains, including bed and chair transfer, ambulation, ascending/descending 1 step, and gait aid used, 0 (independent in all activities without a gait aid) to 36 (unable to attempt any of the activities). Day 5 or day of discharge (if earlier)

Timed Up and Go test Day 5 or day of discharge (if earlier)

Length of stay (acute, inpatient rehabilitation, combined)

Inpatient complication

Re‐admission

SF‐12, EQ‐5D (6 months)

Discharge destination

Death

Notes

Resource use collected: physiotherapy hours of service, acute / rehab / combined hospital length of stay

Funding: Victorian Department of Health (Workforce Innovation and Allied Health)

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Participants were randomly assigned by computer program"

Allocation concealment (selection bias)

Unclear risk

Allocation concealment not specified. Insufficient information to permit judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear. The usual care physiotherapist was blinded to allocated group.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

Blinding specified for Modified Iowa Level of Assistance, Timed Up and Go test.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

Blinding not specified, but likely as data were collected from Victorian Orthopaedic Trauma Outcomes Registry, for SF‐12, EQ‐5D and Glasgow Outcome Scale. Blinding not specified for length of stay, inpatient complications, re‐admissions. Outcome measurement is unlikely to be influenced by lack of blinding.

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

Unclear risk

Health‐related quality of life data derived from data in the Victorian Orthopaedic Trauma Outcomes Registry. Can assume this was collected by personnel blinded to the study.

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Unclear risk

Timed Up and Go test performed only for people who could walk, so only 40/92 (42%) of participants contributed to this measure. All participants contributed to other measures at 5 days postop.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Low risk

13/92 (14%) lost to follow‐up at 6 months

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

Low risk

15% lost to follow‐up at 6 months for health‐related quality of life

Selective reporting (reporting bias)

Low risk

All outcomes specified in trial registry and methods section were reported in the results

Free from baseline imbalance bias?

High risk

There were statistically significant between‐group differences in anaesthetic type (general versus spinal), proportion of men, and having a carer at home.

Free from performance bias due to non‐trial interventions?

Low risk

Care and experience of care providers was consistent across groups

Study characteristics

Methods

Randomised trial (randomisation was stratified for fracture type (trochanteric/femoral neck))

Participants

Acute orthopaedic ward at a university hospital, Copenhagen, Denmark
Period of study: October 2013 to May 2015
90 participants
Inclusion: home‐dwelling, primary hip fracture surgery, aged 65 years or older, able to speak and understand the Danish language, independent pre‐fracture indoor walking ability equal to a New Mobility Score ≥ 2
Exclusion: multiple fractures, weight‐bearing restrictions, people unwilling to participate in appropriate rehabilitation or unable to co‐operate in tests, terminal illness, and treatment with total hip arthroplasty or parallel pins
Age: mean (SD) 79.6 (7.56)
% male: 23
Number lost to follow‐up: 10 (restrictions after X‐ray n = 1, re‐fracture n = 1, discharge without notice n = 2, declined assessment n = 1, death n = 2, transferred n = 2, incomplete follow‐up test of fractured limb n = 1)

Interventions

1. Intervention: routine physiotherapy* plus additional daily individual progressive knee‐extension strength training with 3 sets of 10 repetitions performed with an intensity of 10 repetition maximum (10 RM), defined as ±2 RM of the fractured limb using ankle weight cuffs.

2. Control: routine physiotherapy*

*Routine physiotherapy: basic mobility and exercise therapy primarily aimed at lower extremities following a guideline with 12 specific lower limb exercises, progressed individually and conducted daily on weekdays with 1 to 2 contacts per day (weekends included postoperative day 1 to 3 only). Repetitions and intensity were not standardised. Also basic mobility activities, balance and stair climbing aimed at regaining physical function corresponding with levels of pre‐fracture habitual activity, and progression of walking aids.

Outcomes

Change in maximal isometric knee‐extension strength (N·m/kg) in the fractured limb in percentage of non‐fractured limb (Maximal Voluntary Torque per kilo body mass) from inclusion to postoperative day 10 or discharge (follow‐up), using belt‐fixed handheld dynamometer

Timed Up and Go test, measured as early as possible after surgery when participant could walk independently with rollator and at follow‐up using a rollator as a standardised walking aid

Independent mobility at discharge (scored using Cumulated Ambulation Score)

Length of admission (postoperative day of discharge)

Discharge destination

Pain. Hip‐fracture‐related pain at rest and during outcome assessment, evaluated by Verbal Ranking Scale (score 0 to 4) using the highest pain level reported from each session

Death

Notes

The stratification on fracture type was violated in the last 10 included participants due to slow inclusion of participants with a femoral neck fracture, allowing more participants with trochanteric fractures (n = 52) to enter the study compared to femoral neck fractures (n = 38). Measured gait speed and independent mobility, but no data presented.

Measured adherence

Funding: grants from The IMK Foundation (LK), The Research Foundation of the Capital Region (MTK), The Research Foundation of the Danish Physical Therapy

Conflict of interest: none declared

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"[Randomly] allocated to two different postoperative in‐hospital rehabilitation interventions by a neutral person (blinded to outcomes and patient characteristics) via a computer‐generated list"

Allocation concealment (selection bias)

Low risk

"[Notes] placed in sealed envelopes and marked with participant numbers only"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

Outcome assessor was blinded to group assignment.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Unclear risk

Method of assessing death was unclear.

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Unclear risk

Timed Up and Go test and timed 10 m walk were performed only for people who could walk;unclear what percentage of participants contributed to these measures

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Low risk

10/90 (11%) lost to follow‐up

Selective reporting (reporting bias)

High risk

Protocol appended to paper. Thigh and lower leg circumference is an outcome in protocol, but not reported. Protocol states Timed Up and Go test, 10‐Metre Walk Test, New Mobility Score, and isometric strength would be assessed at 16 weeks, but these were not reported in results paper. Data not presented for 10m walk time, but between‐group difference is reported.

Free from baseline imbalance bias?

Low risk

No imbalance noted

Free from performance bias due to non‐trial interventions?

Low risk

Care and experience of care providers appears consistent across groups

Study characteristics

Methods

Randomised trial: use of sequentially‐numbered, sealed, opaque envelopes; stratified by pre‐injury mobility

Participants

John Radcliffe Nuffield Orthopaedic Hospital, Oxford, UK
Period of study: not stated, earliest report located 1998
27 female participants
Inclusion: women aged ≥ 75 years who had surgical fixation (not total hip replacement) of a hip fracture, living in own home or a relative's home or in sheltered housing before their injury. Written informed consent
Exclusion: history of stroke or Parkinson's disease, clinical depression or acute mental illness, cognitive impairment: 6 or lower on the Hodkinson Mental Test Score. Other fracture, respiratory or cardiac failure sufficient to prevent walking 50 feet (15.25 m), systolic blood pressure > 200 mmHg or diastolic blood pressure > 100 mmHg, surgical complications, pathological fracture. At medication assessment at day 6: on hypnotics, sedatives, muscle relaxant or medications likely to affect muscular function during postoperative period.
Age: mean 84 years (range: not stated)
% male: none
Number lost to follow‐up: 3 excluded. One had myasthenia gravis (confirmed independently as not related to trial), one a severe chest infection and the third participant withdrew consent after a few days.

Interventions

Early postoperative rehabilitation, started at 7 days after surgery.
1. Patterned neuromuscular (electrical) stimulation of the quadriceps muscle for 3 hours a day for 6 weeks. Stimulus intensity was the minimum required for visible muscle contraction. Each stimulus delivered 0.3 micro coulomb of charge.
versus
2. Placebo stimulation for same time period.

Interventions started in hospital 1 week after surgery and continued at participants' homes after hospital discharge at 10 to 14 days. A trained assistant, who was independent of the study, showed the participants how to apply the stimulator.

Outcomes

Length of follow‐up: 12 weeks after randomisation (13 weeks after surgery)

Recovery of mobility
Walking velocity
Leg extensor power
Compliance
Pain (1: no pain to 6: severe pain)
Side effects (none)

Notes

Patterned neuromuscular (electrical) stimulation is "a variable frequency stimulus (mean frequency 8.9 Hz) derived from the discharge of a fatiguing motor unit of the quadriceps".

The stimulator was designed for home use, being portable and independent of an electric supply. Difficulties found by the participants in changing the batteries meant that weekly visits were required by study personnel.

Funding: Research into Ageing and the PPP Healthcare Charitable Trust.

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

“Randomization lists were prepared in advance of the study with a random number table.”

Allocation concealment (selection bias)

Low risk

“Assignments were placed in sealed, numbered, opaque envelopes that were opened in a strict sequence after eligibility had been established and consent obtained.”

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Good attempt made to blind participants with placebo stimulation.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

“The investigator responsible for measuring outcomes and all participants were blind to the treatment assignment."

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

Only complications reported, blinding indicated, and assessment of this outcome is unlikely to be influenced by knowledge of group allocation.

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Unclear risk

No data, including group allocation, presented for the 3 people who did not complete the study

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Unclear risk

Only complications reported

Selective reporting (reporting bias)

Unclear risk

Probably, but no trial protocol or trial registration available

Free from baseline imbalance bias?

Unclear risk

Incomplete report of baseline data as those for the 3 post‐randomisation exclusions were not available. No major differences in the available data for those followed up.

Free from performance bias due to non‐trial interventions?

Low risk

No obvious differences. Both arms included similar usual care.

Study characteristics

Methods

Randomised trial

Participants

Acute orthopedic unit in metro Vancouver teaching hospital, Vancouver, BC, Canada

Period of study: November 2013 to September 2014

30 participants

Inclusion: community‐dwelling adults with a recent fall‐related hip fracture ≥ 60 years of age, recruited following surgical repair. English speaking

Exclusion: fracture related to metastatic disease or bisphosphonate use, did not return home in the community after hospital discharge, medical contraindications restricting activity and exercise, hearing or speech impairments precluding telephonic communication, or physician‐diagnosed dementia.

Age: mean 82.5 years (range 61 to 97)

% male: 37%

Number lost to follow‐up: 4 (postoperative complications n = 3, moved to residential care n = 1)

Interventions

Additional post‐discharge physiotherapist telephone support and coaching

1. Telephone support and coaching: usual care plus 1‐hour in‐hospital individualised education session using the hip fracture recovery manual and 4 educational videos (FReSH Start), plus up to 5 phone calls in the first 4 months post‐fracture from research physiotherapist (average 151 minutes of phone time). Phone calls focused on goal setting regarding recovery goals, mobility goals, adherence to exercise programme and community reintegration.

2. Usual care: usual care plus 1‐hour in‐hospital individualised education session using the hip fracture recovery manual and 4 educational videos (FReSH Start).

Usual care included follow‐up physician and surgeon visits, and usual rehabilitation and home care as appropriate.

Outcomes

Length of follow‐up: 4 months

Mobility (observed): 4‐Metre Walk Test

Mobility (self‐reported): use of mobility aid

Quality of life (EQ‐5D‐5L)

Strength: grip Strength

Adverse events: falls (risk and number), re‐admissions (30‐day)

Pain

Notes

Funding: nil

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Web‐based randomisation service. Stratified randomisation by sex and age group

Allocation concealment (selection bias)

Low risk

An independent statistician from an off‐site consulting firm generated the allocation sequence.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and the participants were not blinded to the group assignment. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

High risk

Participants, the research physiotherapist and study co‐ordinator were aware of treatment allocation. Outcome assessment completed by research physiotherapist

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Unclear risk

Participants, the research physiotherapist and study co‐ordinator were aware of treatment allocation. Outcome assessment completed by research physiotherapist. Unclear how this affected objective outcomes

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

High risk

Health‐related quality of life: participants, the research physiotherapist and study co‐ordinator were aware of treatment allocation. Outcome assessment completed by research physiotherapist. Risk of bias for health‐related quality of life = high

Falls: ascertained by the same method in both groups, self‐reported by participant. Blinded assessors monitored monthly via telephone. Risk of bias for falls = unclear

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

High risk

27% of intervention group participants were lost to follow‐up (3 postop complications, 1 residential care admission). No control group participants were lost to follow‐up.

The disproportionate loss in intervention and control groups may affect the outcome and it is possible those lost due to complications had different mobility.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

High risk

27% of intervention group participants were lost to follow‐up (3 postop complications, 1 residential care admission). No control group participants were lost to follow‐up.

The disproportionate loss in intervention and control groups may affect the outcome and it is possible those lost due to complications would have been more likely to be re‐admitted.

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

High risk

27% of intervention group participants were lost to follow‐up (3 postop complications, 1 residential care admission). No control group participants were lost to follow‐up. Those excluded due to complications more likely to have reduced quality of life and greater risk of falls.

Selective reporting (reporting bias)

Low risk

Outcomes not reported in published manuscript were provided by author.

Free from baseline imbalance bias?

Low risk

No significant differences at baseline; additional outcomes provided by author.

Free from performance bias due to non‐trial interventions?

Unclear risk

Incomplete assurance of comparability of other care provided to the 2 groups.

Method of ascertaining falls

Low risk

Monitored falls via prospective self‐reported daily falls diary and monthly telephone calls by a research assistant blinded to group allocation.

Study characteristics

Methods

Randomised trial

Participants

Greater Boston, Massachusetts, USA

Period of study: September 2008 to October 2012

232 participants enrolled

Inclusion: primary diagnosis of hip fracture, > 60 years, discharged from rehabilitation ≤ 20 months of baseline assessment, can understand and communicate in English, able to safely and independently move from sitting to standing ± mobility device, have a functional limitation (defined as a limitation in at least 1 of the tasks listed in the Short Form‐36 physical function scale)

Exclusion: significant cognitive deficits (i.e. a Mini Mental State Examination score of < 20), severe depression (i.e. a score of ≥ 10 on the short form of the Geriatric Depression Scale), a terminal illness (survival expected to be < 1 year), significant pulmonary or cardiovascular contraindications or preexisting conditions that precluded participation in an exercise programme, legally blind, currently receiving rehabilitation therapy, lived outside of the study’s catchment area in New England, had a bilateral hip fracture, hip fracture was the result of a malignancy, it had been more than 24 months since the hip fracture at enrolment in the study, or had a rapidly progressive

neurological disease.

Age: mean 78.0 (SD 9.9) years

% male: 31%

Number lost to follow‐up: 53

Interventions

6‐month programme

1. Home exercise intervention: exercise intervention 3 times per week for 6 months. Training by physical therapist with monthly telephone calls. Cognitive and behavioural strategies used. Participants given DVD of programme and DVD player if necessary. Programme: simple functional tasks based on Strong for Life programme using Thera‐Bands for resistance. Standing exercises with steps and weighted vests. Based on Increased Velocity Exercise Specific to Task (INVEST), Sherrington and Lord programmes.

2. Attention control: same frequency of contact as intervention group but with registered dieticians. Nutrition education for cardiovascular health based on the Dietary Guidelines for Americans. Single home visit of 1 hour, followed by a series of telephone calls of approximately 30 minutes’ duration, and mailings.

Outcomes

Length of follow‐up: 6 months (at end of intervention), 9 months (3 months post‐intervention)

Mobility (observed): Short Physical Performance Battery

Mobility (self‐reported): Activity Measure‐Post Acute Care (AM‐PAC) mobility

Function: AM‐PAC daily activity

Balance (observed): Berg Balance Scale

Strength: knee extension force

Other outcomes not included in review: self‐efficacy, modified falls self‐efficacy, outcomes expectations for exercise scale

Notes

Measured adherence

Funding: National Institute of Nursing Research. Thera‐Band products were donated by Thera‐Band.

Conflict of Interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computerised central randomisation scheme generated by the study biostatistician

Allocation concealment (selection bias)

Unclear risk

Inadequate information to support judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

Function assessed by blinded assessors

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

Unclear risk

Blinded assessors

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Low risk

Losses and reasons balanced between groups. 21.7% loss from intervention group versus 24.1% loss from control group, but reasons balanced and accounted for in multiple ways in analysis

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Low risk

Losses and reasons balanced between groups. 21.7% loss from intervention group versus 24.1% loss from control group, but reasons balanced and accounted for in multiple ways in analysis

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

Low risk

Losses and reasons balanced between groups. 21.7% loss from intervention group versus 24.1% loss from control group, but reasons balanced and accounted for in multiple ways in analysis

Selective reporting (reporting bias)

Low risk

Outcomes reported as per trial registration

Free from baseline imbalance bias?

Low risk

Groups balanced at baseline

Free from performance bias due to non‐trial interventions?

Low risk

No obvious other differences between groups.

Study characteristics

Methods

Randomised trial: use of consecutively‐drawn, numbered, sealed, opaque envelopes

Participants

Rehabilitation Unit, Hvidovre Hospital, Copenhagen, Denmark
Period of study: not stated
88 participants
Inclusion: women aged 60 to 89 years transferred to a rehabilitation unit within 3 weeks after surgical treatment (osteosynthesis or partial hip replacement) of an "uncomplicated" hip fracture, full mobility prior to fracture, full weight bearing allowed, no concomitant disabling disorders, informed consent
Exclusion: women who fell ill during the trial with symptoms that hindered training for more than 2 days; women discharged before attaining the planned functional capacity. (These appear to be post‐randomisation exclusion criteria.)
Age: median 80 years (range 61 to 89 years)
% male: none
Number lost to follow‐up: none (37 dropouts still accounted for in analyses)

Interventions

Early postoperative rehabilitation
1. Participants were offered 6 hours per week of intensive physiotherapy, comprising 2 hours on Monday, Wednesday and Friday
versus
2. Standard physiotherapy of 15 to 30 minutes per weekday

Qualitative content of the 2 programmes were identical: bench exercises, gait, balance, co‐ordination, stair climbing and, in some cases, hydrotherapy.

Training was stopped when the planned functional capacity was attained unaided (walk 50 or more metres without resting in 2 minutes or less, using walking stick or quadruped if necessary; climb 1 flight of stairs; manage sit‐to‐stand transfer; move in and out of bed; manage bathing, dressing and lavatory visits) or when participants withdrew from study.

Outcomes

Length of follow‐up: until discharge from hospital

Use of walking aids
Orthopaedic complication
Length of hospital stay
Duration of training and length of training period
Dropouts from training

Notes

Details of the method of randomisation provided on contact with lead trialist, but no other information gained.

The current account of the trial is based on the report in the Danish Medical Bulletin. A colleague, Pernille Jensen, based in Denmark, checked through the paper written in Danish (in Ugeskr Laeger) and confirmed that, with the exception of a few small details, the English paper was a straight translation.

Participants in the intervention arm spent significantly more total hours training and significantly more hours per day training than those in the control arm.

Measured adherence

Funding: none declared

Conflict of interest: none declared

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"Patients were randomised"

Allocation concealment (selection bias)

Low risk

Letter from authors to Martyn Parker (06 August 2002): "numbered sealed opaque envelopes drawn consecutively"

Blinding of participants and personnel (performance bias)
All outcomes

High risk

"A blinded evaluation was performed by an external observer when the treating physiotherapist considered that the objective [attainment of functional capacity] had been obtained." However, this was after a non‐blinded person had assessed achievement of functional goals.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

High risk

"A blinded evaluation was performed by an external observer when the treating physiotherapist considered that the objective [attainment of functional capacity] had been obtained." However, this was after a non‐blinded person had assessed achievement of functional goals.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Unclear risk

Blinding not specified. Unclear how assessment of adverse effects is influenced by potential knowledge of group allocation

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Low risk

Data provided for all participants for intention‐to‐treat analysis as well as per‐protocol analysis

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Low risk

Data provided for all participants for intention‐to‐treat analysis as well as per‐protocol analysis

Selective reporting (reporting bias)

Unclear risk

Possible but no confirmation

Free from baseline imbalance bias?

Low risk

Baseline comparability evident

Free from performance bias due to non‐trial interventions?

Unclear risk

Incomplete assurance of comparability of other care provided to the 2 groups

Study characteristics

Methods

Parallel, 2‐group, randomised clinical trial

Participants

Conducted at 3 clinical centres in the USA: Arcadia University, University of Connecticut Health Center, and University of Maryland, Baltimore
Period of study: September 2013 to October 2017
210 participants
Inclusion: minimal trauma, closed, non‐pathologic hip fracture with surgical repair; age 60 years and older; community‐dwelling at time of fracture and randomisation; ambulating without human assistance 2 months before the fracture; and walking less than 300 m during the 6‐Minute Walk Test at the time of randomisation
Exclusion: medical contraindications for exercise, low potential to benefit from the intervention, and practical impediments to participation
Age: mean (SD) 80.75 (8.4)
% male: 23
Number lost to follow‐up: 13

Interventions

For both treatment groups, physical therapists provided 60‐minute in‐home intervention visits on non‐consecutive days for 16 weeks. The first 75 participants = 3 visits per week during the first 8 weeks and 2 visits per week during the remaining 8 weeks (40 assigned visits). Participants randomised after the protocol change = 2 visits per week (32 assigned visits). Participants in both groups received 2000 IU of vitamin D3, 600 mg of calcium and a multivitamin daily for 40 weeks. A registered dietician provided nutritional counselling at baseline. Additional dietician consults were provided by telephone if participants lost 2% or more of weight over 4 weeks.

1. Intervention: strength training using portable progressive resistance device, 3 sets of 8 repetitions at 8 RM or body weight, per leg, for 4 muscle groups (leg press, hip abduction, hip extension and heel raises). Intensity reassessed every 2 weeks. Endurance training (outdoor ambulation, indoor walking or other upright activity), aiming for 20 minutes at 50% of heart rate reserve.

2. Active control: "These activities were selected because they are common physical therapy interventions but were not expected to have an effect on walking ability". Seated active range‐of‐motion exercises (neck, trunk, upper and lower limbs), progressed from 3 to 20 repetitions per exercise, target volume > 20 minutes. Sensory‐level TENS unit application to lower extremity muscle groups, frequency = 80 pulses/second, pulse duration = 50 microseconds, and amplitude to produce a minimally detectable tingling sensation to each muscle complex for 7 minutes. Target volume = 21 minutes per session.

Outcomes

16 weeks:

6‐Minute Walk Test

Short Physical Performance Battery

Balance subscale of Short Physical Performance Battery, and 2 additional single leg stands (eyes open and eyes closed) as used in the National Health and Aging Trends Study (NHATS)

Quadriceps Muscle Strength

Modified Physical Performance Test

Gait speed (fast walking, 50 feet)

Notes

ClinicalTrials.gov Identifier: NCT01783704

Protocol modified during study: reduced target sample size from 300 to 210, expanded eligibility criteria, removed 1 outcome time point (40 weeks), reduced intervention intensity from 3 days/week to 2 days/week

Measured adherence

Funding: Dr Beamer reported receiving grants from the NIA/NIH and Veterans Affairs. Dr Binder reported receiving grants from Astellas Pharma and an interview stipend from Pfizer. Dr Miller reported being a full‐time employee of Novartis Institutes for Biomedical Research. Ms McBride reported receiving grants from the University of Maryland School of Medicine. Dr Craik reported receiving grants from the NIH and personal fees from the University of Maryland School of Medicine, as well as serving on the external advisory board of the Pepper Center at the University of Maryland School of Medicine. No other disclosures were reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The random allocation sequence...was implemented using a secure web‐based system. Treatments were assigned according to separate randomization schedules for each clinical site, in randomly ordered blocks of randomly selected sizes of 2, 4, 6, or 8, with equal numbers of participants assigned to each treatment within each block".

Allocation concealment (selection bias)

Low risk

Randomisation "implemented using a secure web‐based system"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Unclear risk

Quote: "Assessors who measured outcomes were blinded to treatment group; participants were instructed not to discuss group assignments with assessors". 3 cases of unblinding of assessment staff were reported, all in the training group.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

Unclear if assessors were blinded for phone calls: quote: "Information on reportable adverse events, including serious or unexpected adverse events or injury that occurred under supervision by study staff, was obtained by telephone interview every 4 weeks". Bias unlikely for mortality

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Low risk

Less than 20% loss to follow‐up

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Unclear risk

Less than 20% loss to follow‐up

Selective reporting (reporting bias)

Low risk

Authors specify certain outcomes are not reported in this paper, including cost‐effectiveness, quality of life (Short Form‐36 not reported), and activities of daily living (Pepper Assessment Tool for Disability)

Free from baseline imbalance bias?

Low risk

Groups balanced at baseline

Free from performance bias due to non‐trial interventions?

Low risk

For both treatment groups, physical therapists provided 60‐minute in‐home intervention visits on non‐consecutive days for 16 weeks. At study initiation, physical therapists were randomly assigned to treatment groups.

Study characteristics

Methods

Randomised trial: use of a list of computer‐generated random numbers

Participants

Community‐dwellers in the vicinity of Arcadia University, USA
Period of study: not stated
41 participants
Inclusion: people aged 65 years or over living at home after successful hip fracture surgery (partial or total hip replacement or internal fixation) who were willing to go to Arcadia University for assessment, discharged from other physical therapy, informed consent
Exclusion: medical contraindications (unstable angina; uncompensated heart failure; on renal dialysis) to resistance or aerobic exercise, stoke with hemiplegia, Parkinson's disease, life expectancy less than 6 months, Mini Mental State Exam score < 20, living in nursing home
Age (of 33 completers): mean 79 years (range 64 to 89 years)
% male (of 33 completers): 27
Number lost to follow‐up: 8 (1 unable to perform prescribed exercises, 2 withdrew consent, 1 diagnosis of progressive neuromuscular disorder, 4 hospitalisations of whom 2 died)

Interventions

The two intervention groups (1 and 2) received high‐intensity home‐based exercise supervised by a physical therapist in 20 visits over 12 weeks: twice‐weekly for 8 weeks and once‐weekly for 4 weeks. Each session lasted 30 to 40 minutes.
1. Resistance training group did 3 sets of 8 repetitions at 8 RM intensity using a portable resistance exercise machine for hip extensors, hip abductors, knee extensors and plantar flexors
versus
2. An aerobic training group did activities that increased the heart rate to 65% to 75% of age‐predicted maximum for 20 continuous minutes (walking, stair climbing or ROM exercises)
versus
3. Control group: bi‐weekly mailings on a variety of non‐exercise topics. Participants asked not to begin any new exercise programmes until the study was completed. They were told that they were eligible to receive either of the exercise interventions at the end of the study.

Outcomes

Length of follow‐up: 12 weeks; but only 8 weeks for the control group.

6‐Minute Walk Test distance
Maximum voluntary isometric force of the lower extremity
Fast gait speed
SF‐36 physical function
Mortality

Notes

Measured adherence

Funding: Foundation for Physical Therapy Research Grant

Conflict of interest: none declared

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"..assignment to a group was determined by referring to a list of computer‐generated random numbers"

Allocation concealment (selection bias)

Unclear risk

Unclear if allocation concealed

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

"The physical therapist examiner was masked to group assignment and performed all testing at baseline and after treatment. Different physical therapists provided the interventions and were masked to outcome testing results." There is no indication on whether the participants were told not to inform the assessor of their group allocation.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

Outcomes are clearly reported and unlikely to be affected by lack of blinding.

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

Unclear risk

"The physical therapist examiner was masked to group assignment and performed all testing at baseline and after treatment. Different physical therapists provided the interventions and were masked to outcome testing results."

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

High risk

Participant flow diagram provided but differential loss to follow‐up (6 from the resistance training group of 8 overall)

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Low risk

Participant flow diagram provided

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

Unclear risk

Participant flow diagram provided but differential loss to follow‐up (6 from the resistance training group of 8 overall)

Selective reporting (reporting bias)

Unclear risk

No protocol available. However, the 2 conference abstracts point to consistency in reporting.

Free from baseline imbalance bias?

High risk

Baseline data provided for only 33 of 41 participants. There were some between‐group differences, which may have been clinically significant. In particular, participants in the control group were more depressed and the time from surgery to the start of the study was around 7 weeks more in the 2 exercise groups compared with the control group (19.4 versus 19.7 versus 12.6 weeks).

Free from performance bias due to non‐trial interventions?

Unclear risk

Variation in delivery by the 6 physiotherapists may have occurred.

Study characteristics

Methods

Randomised controlled trial

Participants

Community‐dwellers in the Bucks and Montgomery county area (Pennsylvania), USA.

Period of study: June 2003 to January 2006

26 participants

Inclusion: community‐dwelling before fracture, successful fixation of a hip fracture within previous 6 months, aged ≥ 64 years, physician referral, discharged from physical therapy

Exclusion: medical history of unstable angina pectoris or uncompensated congestive heart failure, ongoing chemotherapy or renal dialysis, history of stroke with residual hemiplegia, Parkinson’s disease, absence of sensation in the lower extremities due to sensory neuropathy, life expectancy < 6 months, MMSE < 20, walking speed < 0.3 m/s or > 1.0 m/s.

Age: mean 80.7 years (SD 5.95)
% male: 19

Number lost to follow‐up at 10 weeks = 5, at 12 months after fracture = 10

Interventions

10‐week programmes delivered by licensed physical therapist.

1. Progressive resistance exercise: leg strengthening exercises, strengthening exercises for the hip extensors and abductors, knee extensors, and ankle plantar flexors bilaterally because of the role of these muscles in gait and transfers. 2x weekly for 20 weeks, total of 20 sessions of 30 to 40 minutes. Intensity: 8 repetition maximum (RM), volume: 3 sets of 8 RM.

2. Control: TENS ("Attentional control group"), at or above the sensory threshold but below the motor threshold, with no visible muscle contraction. Intensity not progressed. Bilateral gluteal muscles (hip extensors and abductors), knee extensors, and ankle plantar flexors were stimulated for 7 minutes for a total of 21 minutes each session. Guided imagery also.

Outcomes

Length of follow‐up: 10 weeks (end of intervention, used in analysis); study also reported outcomes 26 weeks after randomisation (12 months after fracture)

6‐Minute Walk Test

HRQoL: SF‐36 physical function

Fast gait speed

Strength (lower extremity torque)

Modified Physical Performance Score

Notes

Measured adherence

Adverse events not systematically assessed

"By having a physical therapist administer the placebo TENS and imagery each treatment session, it was possible to control for attention and motivation...".

Funding: National Institutes of Health, National Institute of Child Health and Human Development, National Institute on Aging Grant 1 R03 HD041944‐01A1

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information for judgement. Quote: "using an unrestricted randomization method"

Allocation concealment (selection bias)

Low risk

Quote: "opaque sealed envelopes"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Participants possibly blinded due to placebo transcutaneous electrical nerve stimulation (TENS). Therapists not blinded; effect of non‐blinding unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

Assessors were blinded to group allocation.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Unclear risk

Method of assessing complications is unclear; however, it does not appear to be blinded.

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

Unclear risk

Assessors were blinded to group allocation.

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

High risk

Less than 20% (19%) lost to follow‐up at 10 weeks; however, 31% lost to follow‐up at 26 weeks

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Unclear risk

Method of assessing complications is unclear

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

High risk

Less than 20% (19%) lost to follow‐up at 10 weeks; however, 31% lost to follow‐up at 26 weeks

Selective reporting (reporting bias)

Unclear risk

No trial registry or protocol paper; outcomes in methods section are reported in the results

Free from baseline imbalance bias?

Low risk

Groups comparable at baseline

Free from performance bias due to non‐trial interventions?

Low risk

Quote: “Licensed physical therapists conducted treatment sessions for both groups”. TENS used as an active control

Study characteristics

Methods

Randomised controlled trial

Participants

Orthopaedic wards of Flinders Medical Centre, Adelaide, Australia
Period of study: recruitment September 2000 to October 2002
63 hip fracture patients (out of a total of 75 participants with fall‐related lower limb fracture)
Inclusion: age 70 years or over, fall‐related lower limb fracture, resident in Southern Adelaide, malnourished ( < 25thpercentile for mid‐arm circumference for older Australians), written consent by patient or next of kin.
Exclusion: unable to understand instructions for positioning of upper arm, could not full weight bear on side of injury > 7 days post admission, not independently mobile pre‐fracture, medically unstable > 7 days post admission, cancer, chronic renal failure, unstable angina, diabetes.
Age (of 75): mean 83.5 years
% male (of 75): 23
Number lost to follow‐up: 5 (3 dead at 12 weeks and 2 withdrew)

Interventions

Early postoperative rehabilitation. Intervention started from 7 days after fracture.
1. Resistance training supervised by a physiotherapist 3 times per week, 20 to 30 minutes per session, for 12 weeks. To ensure standardisation, the trial physiotherapists were instructed to deliver only the structured programme of therapy to participants. Programme incorporated progressive resistance training of the hip extensors and abductors (supine), knee extensors (supine or sitting) and ankle dorsi‐ and plantar‐flexors (supine or sitting). Training was increased as soon as 2 sets of 8 repetitions of the exercise could be completed in good form, judged by physiotherapist.
versus
2. Resistance training plus nutrition: Fortisip (Nutricia Australia Pty Ltd) oral protein and energy supplement (1.5 kcal/mL, 16% protein, 35% fat, 49% carbohydrate) to provide 45% of estimated energy intakes. (Individually prescribed and delivered.) Four doses of equal volume given by nurses from drug trolley, continued after hospital discharge at twice per day or more. Once weekly visits on weeks 7 to 12.
versus
3. Attention control. Usual care and general nutrition and exercise advice. Tri‐weekly visits on weeks 1 to 6, once weekly on weeks 7 to 12. Discussions during these visits were limited to general information (e.g. benefits of regular exercise and nutrient‐dense meals). All participants were encouraged to continue prescribed treatments.

All participants received usual clinical care (including general nutrition and exercise advice, usual dietetic and physiotherapy care, transfer to residential care, rehabilitation facility or directly home).

Outcomes

Length of follow‐up: 12 weeks (mobility outcomes); 12 months (mortality and re‐admissions)
Gait speed
Quadriceps strength
Quality of life (SF‐12 physical component score and mental component score)
Hospital re‐admission
Mortality (reported for hip fracture patients at 12 months. Three‐month time point not used as data reported for non‐hip fracture patients)
Length of hospital stay (acute, rehabilitation, total)

Notes

Measured adherence

Trial population also included 25 other participants (23 with hip fracture) who were allocated to the nutrition‐only intervention group. Data from this group are not included in this review. Of the 14 participants with other lower limb fractures: 6 were pelvic and 8 were of the femur, tibia or fibula.
Further information on trial, including mortality data for hip fracture patients, provided to Alison Avenell by Maria Crotty for the nutrition supplementation review (Avenell 2010).

Started in acute orthopaedic ward and continued after discharge home. Median length of stay (acute and rehab) = 24 days.

Funding: NHMRC Public Health Postgraduate Research Scholarship, Flinders University‐Industry Collaborative Research Grant and Nutricia Australia Pty Ltd.

Conflict of interest: none declared

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Participants were randomized by using a stratified (admission accommodation: community or residential care), block randomization method (blocks of 12) following baseline assessment.” From summary data provided 25 July 2003: "computer generated table of random numbers"

Allocation concealment (selection bias)

Low risk

"The Pharmacy department maintained a computer generated allocation sequence in sealed opaque envelopes."

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Care providers and patients not blinded. Impact of non‐blinding unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

"Research staff blinded to treatment allocation performed outcome assessments (weight, quadriceps strength, gait speed, quality of life) 12 weeks after commencement of trial interventions."

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Unclear risk

Unclear whether research staff were blinded for these outcomes; however, mortality outcomes not likely to be influenced by knowledge of group allocation, uncertain for adverse events

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

High risk

Denominators for gait analysis, quadriceps strength etc. not provided

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Unclear risk

Participant flow diagram provided (for 12 weeks), but inconsistent data provided at 1 year in a summary provided by trialists

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Free from baseline imbalance bias?

Unclear risk

“No significant differences were identified across the four treatment groups.” However, twice as many cognitively‐impaired participants (17) in attention control group compared with combined intervention group (8); 12 in exercise group.

Free from performance bias due to non‐trial interventions?

Unclear risk

No information. More attention control group participants (11) were referred for dietetic intervention, as part of usual care, compared with exercise (6) and nutrition and exercise (5) groups.

Study characteristics

Methods

Randomised controlled trial

Participants

Geriatric Orthopaedic Unit (Lightburn Hospital) connected with Glasgow Royal Infirmary, UK
Period of study: February 1997 to August 1998
80 participants
Inclusion: people aged ≥ 65 years with hip fracture treated surgically, written informed consent
Exclusion: abbreviated mental score < 6/10, previously unable to walk, medically unstable
Age: mean 80 years (range not stated)
% male: 16%
Number lost to follow‐up: 16 (refused or unavailable); also, 7 died and 13 with new comorbidity precluding assessment were not included in final analyses.

Interventions

Early postoperative rehabilitation
1. Twice weekly quadriceps strengthening exercises in both legs for 6 weeks whilst a hospital inpatient on a rehabilitation ward. Sessions involved 6 sets of 12 repetitions of knee extension (both legs), progressing from 50% of participant's 1 RM (weeks 1 and 2), 70% (weeks 3 and 4) and up to 80% (weeks 5 and 6). Participant’s 1 RM (maximum load an individual can lift through full range of knee extension) established initially and at 3 and 5 weeks. Plus usual care.
versus
2. Usual care only. Consisted of conventional physiotherapy for approximately 20 minutes per day, 5 days a week. Initial bed exercises, progressing to bed and chair transfers, gait re‐education and balance training, to practice of functional activities in gym including use of parallel bars.
Participants transferred to a rehabilitation unit at about 15 days (median 15 versus 16 days) after surgery for a hip fracture.

Outcomes

Length of follow‐up: 6 weeks and 16 weeks (16 weeks used in analysis)

Elderly mobility scale
Leg extension power
Walking velocity
Barthel Index
'Get up and go' test
Functional reach
Length of hospital stay
Mortality

Notes

Measured adherence

Funding: none declared

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Randomisation was performed using computer‐generated random numbers"

Allocation concealment (selection bias)

Low risk

"[Group] allocation for each study patient concealed in a sealed envelope and held by a third party who was not otherwise involved in the study"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

High risk

“Recordings were made by a single research assistant who was not blinded to study group allocation.” While “an independent blinded assessor performed repeat measurements of leg extensor in a convenience sample of 18” participants at 6 weeks plus 2 days gave reassuring results, this was not considered an adequate protection against bias.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

Blinding unclear; however, mortality outcome is usually unlikely to be influenced by knowledge of group allocation.

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

High risk

Bias could have occurred given the high loss to follow‐up at 16 weeks (intervention: 50% versus control: 40%).

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

High risk

Bias could have occurred given the high loss to follow‐up at 16 weeks (intervention: 50% versus control: 40%).

Selective reporting (reporting bias)

Low risk

Comprehensive report of outcome including consistent primary outcome

Free from baseline imbalance bias?

Low risk

In all key characteristics

Free from performance bias due to non‐trial interventions?

Low risk

Care other than the trial interventions appears comparable in the 2 groups.

Study characteristics

Methods

Randomised controlled trial

Participants

Scientific Institute of Lissone of the Clinical and Scientific Institutes Maugeri
Period of study: July 2012 to December 2015
52 participants
Inclusion: internal fixation due to extracapsular hip fractures, such as trochanteric, subtrochanteric, pertrochanteric, intertrochanteric, basal and lateral femoral fractures, 7 to 10 days before admission to rehabilitation unit; good understanding of Italian, age > 70 years
Exclusion: previous hip and lower limb surgery, systemic illness, cognitive impairment (Mini Mental State Examination < 24), recent myocardial infarctions, cerebrovascular events, chronic lung or renal diseases
Age: mean (SD) 77.45 (7.0)
% male: 29
Number lost to follow‐up: 3 weeks = 2, 12 months = 5

Interventions

1. Intervention: individual sessions, 90‐minute sessions, 5 times a week for 3 weeks, in‐hospital programme. Balance task‐specific exercises while standing (open and closed eyes, aiming for symmetrical leg loading, proprioceptive pillows under feet, shrinking the support base, or maintaining the tandem position). Walking on a rectilinear trajectory while changing speed and direction, or while performing motor‐cognitive tasks. Additional exercises included moving from a sitting to a standing position, ascending/descending stairs and climbing obstacles.

versus

2. Control: individual sessions, 90‐minute sessions, 5 times a week for 3 weeks, in‐hospital programme. Open kinetic chain exercises in the supine position aimed at improving range of hip motion, increasing hip and lower limb muscle strength, and maintaining the length and elasticity of thigh tissues.

Both groups: gait training with crutches, ergonomic advice

Intervention and control delivered by 1 physiatrist and 2 physiotherapists (i.e. 2 physiatrists and 4 physiotherapists total)

Outcomes

Assessments after randomisation, 3 weeks (used in analysis) and 12 months

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (3 subscales: physical function (primary outcome), pain and stiffness). Subscales scored 0 (best) to 100 (worst health status). Italian version

Pain intensity: 0 to 10 rating scale

Italian Berg Balance Scale

Functional Independence Measure

Short Form‐36 (subscales reported in paper)

Global Perceived Effect Scale at end of treatment

Notes

Funding: nil

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"The principal investigator randomized the subjects to one of the two treatment programmes using a list of blinded treatment codes, generated in MATLAB"

Allocation concealment (selection bias)

Low risk

"An automatic assignment system made in MATLAB to conceal the allocation"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists were not blinded. Attempts were made to blind participants. Quote: "The physiatrists, the physiotherapists and the patients were not blinded. To partially limit expectation bias and to reduce problems of crossover, patients were not made aware of the study’s hypothesis and were told that the trial was intended to compare two common approaches to hip fractures postsurgical rehabilitation, whose efficacy had not yet been established".

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

High risk

Blinding of the secretarial staff collecting data was not specified. Effect of any non‐blinding is unknown; however, baseline assessment was conducted after randomisation, which increases risk of bias.

Quote: "The principal investigator obtaining and assessing the data and the biostatistician making the analyses were both blinded to the treatment allocation". However, the paper states it was secretarial staff that collected the data.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Unclear risk

"Using a specific form, the patients were asked to report any serious and/or distressing symptoms they experienced during the study that required further treatment". Blinding of the secretarial staff collecting data was not specified. Effect of apparent non‐blinding on adverse event outcomes is unclear

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Low risk

Less than 20% of outcome data missing (8% missing, with 2/26 lost to follow‐up in intervention group and 3/26 in control group)

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Low risk

Less than 20% of outcome data missing (8% missing, with 2/26 lost to follow‐up in intervention group and 3/26 in control group)

Selective reporting (reporting bias)

Low risk

All outcomes in trial registration and methods section are reported

Free from baseline imbalance bias?

Low risk

No indication of baseline imbalance bias

Free from performance bias due to non‐trial interventions?

Low risk

Intervention and control delivered by equally experienced physiatrists and physiotherapists

Study characteristics

Methods

Randomised controlled trial

Participants

Inpatient rehabilitation units of 3 teaching hospitals, Sydney, Australia
Period of study: March 2002 to May 2005
160 participants
Inclusion: people with surgical fixation for hip fracture admitted to the inpatient rehabilitation unit from the acute orthopaedic ward. Approval to weight bear or partial weight bear; able to tolerate the exercise programmes; able to take 4‐plus steps with a forearm support frame and the assistance of 1 person; no medical contraindications that would limit ability to exercise; living at home or low‐care residential facility prior to the hip fracture, with the plan to return to this accommodation at discharge. People with cognitive impairment were included if a carer who was able to supervise the exercise programme was available.
Exclusion: high‐functioning patients discharged directly to home and low‐functioning patients discharged to a residential aged care facility from the acute orthopaedic ward. Patients with > 4 adjusted errors on the Short Portable Mental Status Questionnaire if no carer was available.
Age: mean 84 years (range: not stated)
% male: 19
Number lost to follow‐up: 10 (3 withdrew consent; 7 died)

Interventions

Postoperative rehabilitation, started after admission to inpatient rehabilitation unit. Continued at home post discharge.
1. Weight‐bearing exercise twice daily for a total of 60 minutes per day for 16 weeks. Five weight‐bearing exercises were prescribed in addition to walking on a treadmill with partial body weight support using a harness (for inpatients) or a walking programme (after hospital discharge). The 5 weight‐bearing exercises used for both legs included stepping in different directions, standing up and sitting down, tapping the foot and stepping onto and off a block. Hand support could be used if necessary. The exercises were progressed by reducing support from the hands, increasing block height, decreasing chair height and increasing the number of repetitions. This commenced as an inpatient programme, followed by home visits and a structured home exercise programme after inpatient discharge. The home exercise programme incorporated the 5 weight‐bearing exercises used in the inpatient phase, plus a walking programme. The frequency of home visits gradually decreased.
versus
2. Usual care (mainly non‐weight bearing exercise): participants undertook 5 exercises in sitting or lying position plus a small amount of walking using parallel bars or walking aids for a total of 30 minutes each day for 4 weeks. The exercises were progressed by increasing the repetitions and resistance. (This type of exercise programme is commonly prescribed after hip fracture). This commenced as an inpatient programme, followed by weekly home visits and a structured home exercise programme incorporating the same exercises. After 4 weeks, participants were provided with a tailored programme of limited weight‐bearing exercises for 12 weeks and encouraged to continue exercising; no further physiotherapy home visits were undertaken.

"All participants received usual post‐operative mobilisation programme usually provided by other health professionals (e.g. occupational therapists) and any gait aids were progressed as per usual protocols. No other physiotherapy treatments were administered during the trial."

Outcomes

Follow‐up: 16 weeks

Walking ability: able to walk unaided or with sticks
Gait: walking velocity
Strength: knee extension
Balance: step test, sway and functional reach, lateral stability, coordinated stability test, choice stepping reaction time
Physical Performance and Mobility Examination

Sit‐to‐stand time

Barthel Index
Quality of life: EuroQol‐5D
Pain (7‐point ordinal scale)
Subjectively‐assessed outcomes (use of 5‐point Likert scales): current mobility, strength and balance
Falls
Accommodation in the community
Use of community services
Length of hospital stay
Hospital re‐admission
Mortality (stated as unrelated to trial protocol)
Subjectively‐reported negative effects

Notes

Measured adherence

Funding: National Health and Medical Research Council of Australia

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Participants were randomly allocated.... Randomisation was stratified for recruitment site and pre‐fracture Barthel Index (i.e. ≥80/100 or <80/100). The allocation sequence was generated from computer software..."

Allocation concealment (selection bias)

Low risk

"The allocation sequence was .... concealed using consecutively numbered, sealed and opaque envelopes."

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

"Measurements were made by assessors who were blinded to group allocation."

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

The assessment of mortality and re‐admission outcomes are usually unlikely to be influenced by knowledge of group allocation.

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

Unclear risk

Health‐related quality of life: blinded assessors

Falls recorded by participants on falls calendar and assessors blinded. Impact of unblinded participant reporting of falls unclear

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Unclear risk

Participant flow provided and full accounting of loss to follow‐up but differential loss to follow‐up (7 versus 3) could have made some difference

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Unclear risk

Participant flow provided but aside from death, these outcomes not reported for whole groups

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

Unclear risk

Participant flow provided and full accounting of loss to follow‐up but differential loss to follow‐up (7 versus 3) could have made some difference

Selective reporting (reporting bias)

Low risk

Trial registration and consistently well‐reported trial

Free from baseline imbalance bias?

Low risk

"There were no clinically important differences between the groups." Also evident from the presented data

Free from performance bias due to non‐trial interventions?

Unclear risk

Possible; the trialists speculate that one reason for the general lack of differences between the two groups was that the therapists, who were not blinded to group allocation, may have modified the programme for participants in the control group.

Method of ascertaining falls

Unclear risk

Falls were obtained using a falls calendar collected at 4‐week and 16‐week assessments and via a postal survey at 10 weeks.

Study characteristics

Methods

Randomised controlled trial

Participants

Department of Rehabilitation Medicine at a university hospital, South Korea
Period of study: September 2017 to April 2019
45 participants
Inclusion: men and women aged 65 to 90 years old who underwent surgery for femoral neck (intertrochanteric or subtrochanteric) fracture and had sarcopenia (diagnosed as low muscle mass combined with low muscle strength (handgrip strength) and/or low physical performance)

Exclusion: (i) hip surgery for infection, arthritis, implant loosening, or avascular necrosis; (ii) femoral shaft fracture, acetabular fracture, isolated fracture of the greater or lesser tuberosity, or periprosthetic fracture; (iii) pathologic fracture; (iv) combined multiple fracture; (v) revision surgery; and (vi) severe cognitive dysfunction (obey command ≤ 1 step). Refusal to participate in a clinical trial

Age: mean 79 years (range: not stated)
% male: 32
Number lost to follow‐up: 7 (2 withdrew consent; 3 lost to follow‐up; 2 died)

Interventions

Control: standardised rehabilitation treatment, 30 minutes/day each of 10 consecutive working days. Physiotherapist delivered passive hip and knee mobilisation, strengthening of the hip abductor and extensor muscles, transfer and gait training on the floor and stairs during every session. Plus 20 minutes of lower limb exercises in supine position.

Intervention: standardised rehabilitation treatment as above, identical to control group. Plus antigravity treadmill (AGT) for 20 minutes/day for each of 10 consecutive working days. Days 1 to 5 AGT was applied with 50% to 60% of body weight administered at a rate of 1.5 miles per hour. Days 6 to 10 AGT was applied with 70% to 80% of body weight administered at a rate of 1.5 to 1.8 miles per hour. 

Outcomes

Baseline, 3 weeks, 3 months, 6 months

Koval walking ability score

Functional ambulatory category 

Berg Balance Scale 

EuroQol‐5D 

Korean version of the modified Barthel Index 

Hand grip strength 

Notes

Funding: nil

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomisation lists generated by statistician not involved in the intervention

Allocation concealment (selection bias)

Low risk

Sealed, opaque envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists who provided the rehabilitation programme and the participants were not blinded to group. The effect on bias is unclear.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

Researchers conducting outcome measurements were blinded to group.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

Unclear whether researchers ascertaining mortality were blinded. Assessment of mortality outcome is usually unlikely to be influenced by knowledge of group allocation.

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

Unclear risk

Researchers conducting outcome measurements were blinded to group.

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Unclear risk

16% loss to follow‐up

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Unclear risk

16% loss to follow‐up

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

Unclear risk

16% loss to follow‐up

Selective reporting (reporting bias)

Unclear risk

Trial registered prospectively; however, not translated from Korean for assessment at time of publication. May change to 'low risk' after assessment of trial registration

Free from baseline imbalance bias?

Unclear risk

Difference in type of surgery between groups (intervention group had 9 hemiarthroplasty, 9 open reduction and internal fixation (ORIF), 1 total hip joint replacement; control group had 17 hemiarthroplasty, 2 ORIF). Potential effect of this on outcome is unclear

Free from performance bias due to non‐trial interventions?

Low risk

Time in training and staff involved were the same in both groups

Study characteristics

Methods

Randomised controlled trial

Participants

Matterhorn Rehabilitation Hospital, Kure, Japan

Period of study: not reported
27 participants
Inclusion: proximal femoral fracture, surgical management, 90 years of age or older

Exclusion: conservative treatment

Age: mean 90.2 years (range: 90 to 93, SD 1.4)
% male: 0
Number lost to follow‐up: 14 (7 withdrew, 2 excluded, 5 lost to final follow‐up)

Interventions

Additional exercise: treadmill training in addition to standard physiotherapy

1. Body weight‐supported treadmill training for 10 minutes, 4 times per week in addition to standard physical therapy 4 times a week

versus

2. Usual care. No body weight‐supported treadmill training. Standard physical therapy 6 times a week for 40 minutes a day

Outcomes

Follow‐up: at discharge (mean (SD) length of stay in intervention group = 84 (8.6) days, control 77.8 (5.5) days. Therefore, used 81 days (12 weeks) for follow‐up.

Gait speed: 10m walking time

Strength: isometric knee extension

Functional Independence Measure

Length of stay

Adverse events: surgical complications, re‐admission, persistent pain, falls

Notes

Published as conference abstract only. Author provided additional study details by email correspondence.

Funding: none declared

Conflict of interest: none declared

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Reported as 'simple randomisation' in correspondence with author

Allocation concealment (selection bias)

Low risk

Author correspondence: ‘central randomisation’

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

Author reported 'single blind test'

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

Author reported 'single blind test'. Unclear whether researchers ascertaining surgical complications and re‐admission were blinded. Assessment of these outcomes is usually unlikely to be influenced by knowledge of group allocation.

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

Unclear risk

Insufficient information for assessment

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

High risk

Large loss to follow‐up (52%)

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

High risk

Large loss to follow‐up (52%)

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

High risk

Large loss to follow‐up (52%)

Selective reporting (reporting bias)

Unclear risk

No trial registration or protocol identified

Free from baseline imbalance bias?

Unclear risk

Not clearly reported (baseline mobility not available)

Free from performance bias due to non‐trial interventions?

High risk

Time spent in training sessions appears to be different between groups

Method of ascertaining falls

Unclear risk

Not reported

Study characteristics

Methods

Randomised controlled trial

Participants

Acute trauma ward, the Alfred Hospital, Melbourne, Australia
Period of study: March 2004 to December 2004
60 participants
Inclusion: people admitted for surgical fixation of a hip fracture (20 had hemiarthroplasty), written informed consent from patient or carer
Exclusion: pathological fracture, postoperative orders for non‐weight bearing on operated hip, admission from nursing home, non‐ambulant pre‐morbidity
Age: mean 79 years (range 53 to 95 years)
% male: 32%
Number lost to follow‐up: none. Separate data provided for 10 failed early ambulators but also for whole early ambulation group

Interventions

Early postoperative rehabilitation. Participants received routine, standard postoperative medical and nursing clinical care. All participants were transferred to sit out of bed as early as possible after surgery (range 13 to 120 hours).
1. Early assisted ambulation started within 48 hours (postoperative day 1 or 2).
versus
2. Delayed assisted ambulation until after 48 hours (postoperative day 3 or 4).

The same physiotherapy ambulation re‐education programme, implemented for all participants, was implemented once daily over 7 days. Programme included walking re‐education, bed exercise and chest physiotherapy as indicated. The 2 physiotherapists providing treatments received instruction regarding the ambulation protocol to ensure standardisation.

Outcomes

Length of follow‐up: until discharge (1 week after surgery for functional outcomes)

Iowa Level of Assistance Scale (0 = independent; 1 = standby supervision; 2 = minimal assistance; 3 = moderate assistance; 4 = maximal assistance; 5 = failure) for transfers, ambulation and negotiation of 1 step
Walking distance, poor functional mobility (assistance required for transfers, negotiating 1 step), time to first walk
Discharge location
Length of hospital stay
Mortality (in hospital)

Notes

Mean time to surgery was 57 hours (6 to 264 hours)
Trial authors noted that clinical practice was to prescribe bedrest in the presence of cardiovascular challenge.

Funding: none declared

Conflict of interest: none declared

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Patients were randomly allocated, using a computer‐generated program, into one of two time to first ambulation intervals..."

Allocation concealment (selection bias)

Unclear risk

No mention of methods for safeguarding prior allocation concealment

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

"A blinded assessor carried out the testing."

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

High risk

No blinding for discharge arrangements (return to living at home), an outcome which is potentially susceptible to bias

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Unclear risk

Standard deviations not provided and incomplete results for level of assistance scale. While separate data were reported for the 10 failed early ambulators, results were reported for the whole early ambulation group.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

High risk

Very short follow‐up with no post‐discharge data

Selective reporting (reporting bias)

High risk

Trial registration was retrospective

Free from baseline imbalance bias?

Low risk

Baseline comparability evident

Free from performance bias due to non‐trial interventions?

Low risk

"The two physiotherapists who provided the treatments received instruction regarding the ambulation protocol to ensure standardisation."

Study characteristics

Methods

Randomised controlled trial

Participants

Community‐dwelling women attending 1 of 3 Baltimore‐area hospitals, USA

Period of study: November 1998 through September 2004

180 participants

Inclusion: Community‐dwelling women, ≥ 65 years age, screened within 15 days of the fracture, completing at least 80% of the baseline survey, admitted within 72 hours of a non‐pathological hip fracture receiving surgical repair, walking without human assistance prior to the fracture, cognitively intact (i.e. score ≥ 20 on the Folstein Mini Mental State Examination) and received orthopedic surgeon clearance

Exclusion: pathologic fracture; cardiovascular, neurologic, and respiratory diseases that could interfere with exercising independently at home; diseases of the bone (e.g. Paget disease, osteomalacia); metastatic cancer; cirrhosis; end‐stage renal disease; hardware in the contralateral hip; and conditions that increase risk of falling while exercising independently

Age: mean (SD) 82.4 (7) years
% male: 0%
Number lost to follow‐up: 49 did not have 12‐month follow‐up

Interventions

1. Home exercise. Exercise sessions and a self‐efficacy‐based motivational component. Aerobic exercise using a Stairstep (progressed time and ankle weights), upper and lower limb strengthening programme (progressed with resistance and intensity, aiming for 3 sets of 10 reps), and stretching exercises (20‐ to 30‐minute warm‐up and cool‐down periods). Total of 56 exercise sessions over 12 months, frequency reduced over time, supplemented with telephone calls to remind participants to exercise and address any questions or concerns. Participants were expected to perform aerobic activity at least 3 days/week and strength training 2 days/week for 30 minutes.

2. Usual care. Plus information on bone health and management of osteoporosis.

Outcomes

Length of follow‐up: 12 months

Mortality

Discharge to community

Adverse events: re‐admission

Adverse events: persistent pain

Adverse events: falls

Adverse events: treatment‐related

*Additional outcomes displayed graphically not extracted

Adverse events: surgical complication

Other outcomes: discharge to nursing home

Notes

Measured adherence

Funding: this research was supported by the National Institute on Aging, Bethesda, Maryland (grants R37 AG09901, R01 AG18668, R01 AG17082, T32 AG00262), and the Claude D. Pepper Older Americans Independence Center (grants P60 AG12583 and P30 AG028747).

Conflict of interest: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote "PC‐PLAN software37 was used to randomize participants within blocks of 2 or 10"

Allocation concealment (selection bias)

Unclear risk

Allocation method not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Participants and therapists not blinded to group allocation and the effect of this non‐blinding not clear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

Study staff conducting assessments were blind to group assignment. Participants obviously not blinded in presence of self‐report outcomes (SF‐36)

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

Study staff conducting assessments were blind to group assignment. Assessment of mortality outcome is usually unlikely to be influenced by knowledge of group allocation.

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

Unclear risk

Falls ascertained by the same method in both groups. Study staff conducting assessments were blind to group assignment. Impact of unblinded participant reporting of falls unclear

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

High risk

69% and 77% completed all 3 follow‐up visits.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

High risk

69% and 77% completed all 3 follow‐up visits.

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

High risk

69% and 77% completed all 3 follow‐up visits.

Selective reporting (reporting bias)

High risk

Self‐efficacy reported as primary outcome but not included in trial report. Secondary outcomes not reported: dietary intake, time to weight bearing (possibly not enough space in publication, time to exercising reported)

Free from baseline imbalance bias?

Low risk

Groups balanced at baseline

Free from performance bias due to non‐trial interventions?

High risk

Home visits may have had a social effect with these community‐dwelling elderly women; some who had cognitive impairment (Mini Mental State Examination 21 to 25) were included in the trial.

Method of ascertaining falls

Unclear risk

Insufficent data available to make judgement. 'Monthly telephone calls were made to participants to ascertain falls'.

Study characteristics

Methods

Three‐arm stepped‐wedge cluster‐randomised trial

Participants

Skilled nursing facilities, the Netherlands

Period of study: 1 April 2016 to 1 December 2017

240 participants

Inclusion: people > 65 years old with traumatic hip fracture admitted to a skilled nursing facility with an indication of short‐term rehabilitation, living alone and having an MMSE score of 15 or higher

Exclusion: terminally ill, were waiting for permanent placement in a nursing home, or did not give informed consent

Age: mean 84

% of male: 20

Number lost to follow‐up: 89

Interventions

1. Usual care: usual discharge planning, usual physiotherapy (focusing on mobility, muscle strength, balance, transfer and walking), usual occupational therapy (focusing on performance of daily functioning and safety at home)

2. Cognitive behavioural therapy (CBT): usual care, plus 4 weeks of weekly coaching based on CBT, including 5 steps: i) Educate on the importance of physical activity and daily exercise; ii) Ascertain the amount of movement and physical activity during the day and give feedback; iii) Define realistic goals for the performance of daily activities; iv) Agree on an activity plan with the patient and, if needed, practice exercises and activities safely; v) Evaluate progress.

3. CBT plus sensory monitoring: usual care, plus 4 weeks of CBT (above), plus 4 weeks of:

‐ wearing of the physical activity monitor (PAM)‐sensor, sensor monitoring, daily instructions how to wear the PAM

‐ weekly coaching based on CBT, including use of the PAM to: i) Ascertain objectively the amount of movement and number of activities during the day and give feedback; ii) Use as a starting point for discussion about the daily patterns and activities that are important to practice; iii) Make new plans for activities; and iv) Evaluate the progress.

Outcomes

Timepont used = after the intervention stopped, at approximately 4 months after the start of rehabilitation

Canadian Occupational Performance Measure (performance score)

Timed Up and Go test

Modified Katz ADL score

Fall Efficacy Scale International

EuroQol 5D

Service use: number of sessions/duration/content

Notes

This intervention was different to others in this review, yet met the inclusion criteria for a mobility strategy.

The study authors adjusted for clustering in their analyses.

Funding: Dutch grant Fonds Nuts Ohra (1401‐057). MP was supported by the Netherlands Organisation for Scientific Research (NWO) (023.003.059).

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Generated using STATA software

Allocation concealment (selection bias)

High risk

Quote: "After admission to the nursing home, the nursing home physicians will identify potential patients on the basis of the inclusion criteria.” Physicians likely to be aware of allocation of wards as well as participant characteristics, and admission occurred after allocation of wards. Recruitment period 12 months. If participants admitted after allocation of ward, allocation concealment not possible

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Participants and therapists not blinded to group allocation and the effect of this non‐blinding not clear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

Assessors blinded to intervention group (although authors acknowledge potential for unblinding)

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

Unclear risk

Assessors blinded to intervention group (although authors acknowledge potential for unblinding).

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

High risk

Large loss to follow‐up (37% at 4 months, 46% at 6 months). (Statistical modelling with imputation performed for 6‐month analysis)

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

High risk

Large loss to follow‐up (37% at 4 months, 46% at 6 months). (Statistical modelling with imputation performed for 6‐month analysis)

Selective reporting (reporting bias)

Unclear risk

Protocol states Canadian Occupational Performance Measure (COPM)‐physical and COPM‐social are both primary outcomes and will be reported combined. The results paper reports COPM‐p as the primary outcome and COPM‐s as the secondary outcome.

Free from baseline imbalance bias?

Low risk

No important baseline imbalance

Free from performance bias due to non‐trial interventions?

Low risk

No important issues

Cluster‐randomised trials

Low risk

Although recruitment did not occur prior to randomisation, baseline characteristics were reported as well‐balanced, adjustment was made for confounders at baseline and for missing values, no clusters were lost, clustering was adjusted for, and the results are comparable with other trials.

Study characteristics

Methods

Randomised trial using computer program. Allocation by independent project co‐ordinator

Participants

Community‐dwellers and independent ambulators (at time of fracture) who had completed Medicare‐funded rehabilitation recruited from 9 hospitals in the greater Baltimore area, USA
Period of study: August 2000 to September 2005 (last follow‐up)
155 participants (see Notes)
Inclusion: female, aged 65 years or over with a non‐pathological fracture which had occurred within 72 hours of hospital admission, who had surgical repair of their hip fracture. Community‐dwellers and independent walkers before fracture. Free of medical problems that would potentially put them at risk of falls when exercising alone at home alone (e.g. neuromuscular conditions). Score of 20 or higher on the Folstein Mini Mental State Examination. Informed consent.
Exclusion: angina, myocardial infarction, stroke, heart condition, pulmonary oedema, Paget's disease, uncontrolled diabetes, Parkinson's disease, multiple sclerosis, cancer, severe blindness, seizures, gastrointestinal haemorrhage (many criteria were limited to the previous 6 months). See trial registration document for full list (clinicaltrials.gov/ct2/show/NCT00389844).
Age: mean 81 years
% male: 0 (all female)
Number lost to follow‐up: 42 (25 withdrew, 10 impractical/other, 7 died)

Interventions

Planned to initiate the intervention as soon as Medicare‐covered rehabilitation services were completed (generally around 1 month); but start dictated by participants.

1. Exercise‐only component. Exercise sessions with an exercise trainer. Sessions incorporated aerobic exercise using a 'Stairstep' (a 4‐inch stair step with handles on either side for support and balance) for 3 days a week, strengthening exercises for main muscle groups relevant to hip fracture recovery for 2 days a week (11 exercises with Thera‐Band and/or ankle wrist cuff weights up to 3 sets of 10 then weight increased), and stretching exercises (these were part of the warm‐up and cool‐down periods). Time and repetitions individually prescribed. (No encouragement given.)
versus
2. The full 'Exercise Plus' programme, which includes the above together with the Plus component (motivational interventions: addition of education about the benefits of exercise from the same exercise trainer using a booklet, verbal encouragement through goal setting and positive reinforcement, medications/heat/ice (for pain), cueing with posters describing the exercises, a 'Goal Form' and a calendar of daily exercise activities.
versus
3. Routine care

In both treatment groups (1 and 2), visits from the trainer were initially twice a week and then decreased to once a month in the final 4 months of the programme, with weekly telephone calls for those exposed to the 'Plus' (motivation) component of the intervention during the weeks when no visit was scheduled. All visits lasted 1 hour. The maximum number of anticipated visits was 38.

Outcomes

Length of follow‐up: 12 months from injury
Mortality

Notes

Extensive account of rationale published in 2002. Trial funded by the National Institute on Aging and National Institutes of Health.

209 were randomised into 4 groups. The 'Plus' or motivation‐only group (54 participants) is not considered in this review (see Crotty 2010). One participant in the exercise‐only group was excluded because they did not receive surgery.

Measured adherence

Funding: National Institute on Aging grants R37 AG09901, R01‐AG18668, R01 AG17082; Claude D. Pepper Older Americans Independence Center P60‐AG12583; Thera‐Band Academy for contribution of Thera‐Band1 resistive bands.

Conflict of interest: none declared

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Randomization was performed using a freeware computer program. Patient assignment was blocked by hospital to assure equal probabilities within each hospital being assigned to each of the four study groups. Patients were assigned to groups at random with forced balancing of treatment groups within hospital."

Allocation concealment (selection bias)

Low risk

"The resulting randomization scheme was given to the project coordinator and patients assigned as they became available at the indicated hospital. The study nurses involved with recruitment and data collection were blind to randomization."

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

"Study participants were not informed of what specific arm of the intervention they were randomized to (i.e. exercise only, plus only, or exercise plus)." Safeguards were not described. Therapists were not blinded to group allocation.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

"The study nurses involved with recruitment and data collection were blind to randomization".

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Low risk

"The study nurses involved with recruitment and data collection were blind to randomization". Assessment of these outcome is usually unlikely to be influenced by knowledge of group allocation.

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Unclear risk

While participant flow diagram was provided, more participants (10) in the exercise‐only group refused study follow‐up compared with 2 in the usual care group.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Low risk

Participant flow diagram provided.

Selective reporting (reporting bias)

Unclear risk

Retrospective trial registration. Insufficient information but no report of overall health status and muscle strength (as stipulated beforehand)

Free from baseline imbalance bias?

Low risk

No obvious imbalance (all female)

Free from performance bias due to non‐trial interventions?

High risk

Time from fracture to first intervention visit from trainer ranged from 28 to 200 days. Participants indicated when they were willing to have their first visit.

Study characteristics

Methods

Randomised controlled trial

Participants

Community‐dwellers, following discharge from Central Finland Central Hospital
Period of study: not stated
81 participants randomised
Inclusion: age > 60 years; ambulatory and community‐dwelling; operated for femoral neck or pertrochanteric fracture (International Classification of Diseases code S72.0 or S72.1); living in the city of Jyväskylä or in 9 neighbouring municipalities.
Exclusion: living in an institution or confined to bed at the time of the fracture; suffering from severe memory problems (Mini Mental State Examination < 18); alcoholism, severe cardiovascular, pulmonary or progressive (i.e. neoplasm) disease, para‐ or tetraplegic or severe depression (Beck Depression Inventory > 29)
Age: mean 80, SD 7.09
% male: 22
Number lost to follow‐up: 4 (control: 2 dropouts; intervention: 1 dropout, 1 died)

Interventions

1. Intervention: 1 year. Promoting mobility after hip fracture (ProMo): standard care and a home‐based, year‐long programme including evaluation/modification of environmental hazards, guidance for safe walking, pain management, progressive home exercise programme and physical activity counselling. Exercise programme = lower‐limb strengthening exercises for the lower limbs (progressed, resistance bands), balance training in standing position, walking exercises and stretching, 30 minutes; strengthening and stretching = 3x/week, balance and walking exercises = 2 to 3x/week. Physical activity counselling = 2 x 30‐minute face‐to‐face sessions and 3 phone contacts, with personal physical activity plan.

2. Control: standard care, included written home exercise programme with 5 to 7 exercises for lower limbs

Outcomes

Follow‐up: 12 months

Short Physical Performance Battery

Berg Balance Scale

Timed 10 m walk

Perceived difficulties in negotiating stairs. “Are you able to negotiate 1 flight of stairs (5 stairs)?” 5‐item response

Difficulty walking 500 m

Leg extension power (Nottingham Leg Extensor Power Rig)

SF‐36 (HRQoL) (email correspondence: outcomes not available at time of writing)

Mortality

Independent activities of daily living, sum score

Notes

Measured adherence

Funding: nil

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"A computer‐generated group allocation list was generated by a statistician not involved in the recruitment or data collection. Randomization by sex and by surgical procedure (internal fixation vs arthroplasty) was performed in blocks of 10".

Allocation concealment (selection bias)

Low risk

"The study group assignments were enclosed in sealed envelopes"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Participants and therapists not blind to group allocation but impact of non‐blinding unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

Low risk

The researchers who collected the outcome measures were blinded to group allocation.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Unclear risk

Unclear how death and complications were recorded

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Low risk

Less than 20% of outcome data missing

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Low risk

Less than 20% of outcome data missing

Selective reporting (reporting bias)

Low risk

Reporting of outcomes as primary and secondary differs in protocol paper (Sipila 2011) and main results paper (Salpakoski 2015). In addition, some components of the primary outcome mobility‐related disability noted in protocol paper (difficulty walking outdoors, 500 m and 2 km) were not reported in results paper. Emailed author 15 July 2019 to ask if the outcomes were analysed. Email received with comprehensive results provided.

Free from baseline imbalance bias?

Low risk

No imbalance in baseline characteristics

Free from performance bias due to non‐trial interventions?

Low risk

No evidence that therapists delivering care to each group were different

Study characteristics

Methods

Randomised trial: use of random numbers, balanced within blocks of 10 participants, to generate open list

Participants

South Western Sydney, Australia
Period of study: December 1994 to December 1995
44 participants
Inclusion: people aged 60 years or over with a fall‐related hip fracture who had lived in the community beforehand. Discharged from 1 of 4 acute hospitals to home or residential care within 9 months of their fracture. Contactable and consenting
Exclusion: severe cognitive impairment or too ill or immobile to participate as judged by carers
Age (of 42): mean 78.5 years (range 64 to 94 years)
% male: 21
Number lost to follow‐up: 2 (withdrew consent); also 2 excluded at initial assessment. Also mentions: "One further person in the control group was not able to complete all the physical aspects of the assessment because of pain from a fall, later diagnosed as a further fracture."

Interventions

All participants had a preliminary interview and physical assessment lasting about 1 hour. This took place on average 7 months (5 to 9 months) after their injury.
1. Home‐based, weight‐bearing exercises for 1 month. Individuals in the intervention group were provided with stepping block(s) made of old telephone directories wrapped up with tape and shown the exercises by a physiotherapist. They were advised on how many stepping blocks and repetitions to do at least once daily at the start (these ranged from 5 to 50) and told to increase the repetitions gradually. A photograph was taken to help remind the participant of the correct method and they were checked at 1 week (4 to 16 days). Participants also kept a diary.
versus
2. Control (no specific instructions: usual care)

Each telephone directory was 5 cm thick: approximately one‐third of a standard house step.

Outcomes

Length of follow‐up: 1 month (range 27 to 43 days)

Quadriceps strength
Sway and balance
Functional reach
Walking velocity
Subjectively‐assessed balance

Notes

Measured adherence

This trial was excluded in the versions of the review up to Issue 3, 2004 because participants were recruited 7 months after a hip fracture; this was previously outside the time period covered by this review, which then focused on early postoperative rehabilitation.

Additional information obtained from Cathie Sherrington 09 Febrary 2004 and 24 March 2004

Funding: nil

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"[Randomly] allocated in order of contact using a random number method within groups of ten subjects."

Allocation concealment (selection bias)

High risk

Trial investigator reported that "it was not concealed ‐ just a list of subject numbers and group allocation generated by a random number table; subjects were assigned to subject numbers in the order that contact was made with them."

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

High risk

Not blinded

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Unclear risk

The few results are unlikely to be affected.

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

High risk

Not blinded

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Unclear risk

The post‐randomisation exclusion of 2 participants meant that intention‐to‐treat analysis was not done.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Low risk

Few data but complete data provided on contact with trial investigator.

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

Unclear risk

The post‐randomisation exclusion of 2 participants meant that intention‐to‐treat analysis was not done.

Selective reporting (reporting bias)

Unclear risk

Bias unlikely but protocol not available.

Free from baseline imbalance bias?

High risk

Statistically significantly more males in intervention group (8 versus 1). Males generally have poorer prognosis post hip fracture but also may have different baseline strength and attitude to exercises.

Free from performance bias due to non‐trial interventions?

Unclear risk

There was a lack of information on care‐programme comparability.

Study characteristics

Methods

Randomised trial: use of random numbers, balanced within blocks of 6 participants.

Participants

Inpatient rehabilitation wards at Bankstown‐Lidcombe Hospital, Sydney, Australia
Period of study: January 1997 to December 1999
80 participants
Inclusion: people aged 60 years or over with a fall‐related hip fracture who were admitted to rehabilitation wards after surgery; written consent
Exclusion: unable to complete assessment and participate in exercise programme due to a) cognitive impairment (assessed by observation), b) major medical conditions, or c) complications from fracture (if directed to be non‐weight bearing or touch‐weight bearing due to problems with fracture fixation).
Age: mean 81 years (range 64 to 98 years)
% male: 32
Number lost to follow‐up: 3 (1 withdrew consent; 2 with actual or suspected problems with fracture fixation precluding their further participation)

Interventions

Early postoperative rehabilitation. Baseline assessment at mean 18.3 days from fracture. The programme commenced while the participant was on the rehabilitation ward and was carried out each weekday in the rehabilitation gymnasium. Participants (21) were advised to continue the programme at home if discharged before the final assessment.
1. Two‐week programmes of weight‐bearing (weight‐bearing position with support as required) exercise prescribed by a physiotherapist. Exercises were sit‐to‐stand, lateral step‐up, forward step‐up‐and‐over, forward foot taps, and a stepping grid. Exercises initially conducted with support of a walking frame or adjustable‐height tables. Exercises progressed by increasing the number of repetitions, lessening the hand support, increasing the height of blocks, decreasing height of surface from which the participants was standing up, etc.
versus
2. Non‐weight‐bearing (performed in the supine position) exercise prescribed by a physiotherapist. Exercises were hip abduction, hip flexion, hip/knee flexion/extension, end of range knee extension, ankle dorsiflexion/plantarflexion. Exercises were progressed by increasing the number of repetitions undertaken.

For both groups, the treating physiotherapist chose several initial exercises, then added extra exercises in keeping with the participant's capability. Number of repetitions was established on the basis of the participant's initial performance (ranged from 5 to 30 for a single exercise). Participants were encouraged to take prescribed pain relief before exercising.

All participants also received usual physiotherapy intervention involving practice of walking and assessment of tasks needed for discharge (bed mobility, sit‐to‐stand and stair climbing), and usual care from other health professionals (nursing staff, social workers, etc).

Outcomes

Length of follow‐up: 2 weeks

Walking ability: use of supports
Gait: walking velocity, step length, force plate weight‐bearing
Strength: hip abduction and flexion and knee extension
Balance: functional reach, step test and sway
Functional performance measures

Sit‐to‐stand x5
Compliance and assessment of exercises
Subjectively‐assessed (use of ordinal scales): risk of falling, balance, pain, sleep quality, health
Fracture fixation problems
Length of hospital stay

Notes

This trial, previously listed in Ongoing studies under Sherrington 2002, was performed as part of Cathie Sherrington's PhD work.

Additional information provided 15 January 2004 by Cathie Sherrington included further details of method of randomisation and data for self‐assessed outcomes.

Funding: National Health and Medical Research Council; Health Research Foundation Sydney South West; Arthritis Foundation of Australia.

Conflict of interest: none declared

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Patients were randomised into one of two exercise groups using a random number table and randomisation in blocks of six."

Allocation concealment (selection bias)

Low risk

"Subjects were assigned into groups using a concealed randomisation method". Clarification of method by personal communication: "This method involved a list of group allocation by subject number on which group allocation for each subject was concealed by a separate piece of opaque paper. Once the subject had agreed to participate in the trial, one piece of paper was removed to reveal the group allocation for the subject in question without revealing the allocation for subsequent subjects."

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

High risk

Assessor was not blinded to group allocation.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Unclear risk

Unlikely to be affected by the lack of blinding

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Unclear risk

Intention‐to‐treat analysis was done and a participant flow diagram provided. However, the denominators for various outcomes were quite varied.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Unclear risk

Very short follow‐up.

Selective reporting (reporting bias)

Unclear risk

Bias unlikely but protocol not available

Free from baseline imbalance bias?

Low risk

Baseline comparability evident

Free from performance bias due to non‐trial interventions?

Low risk

Care other than interventions under test comparable in both groups

Study characteristics

Methods

Randomised trial: use of random numbers, balanced within blocks of 6 participants. Use of sealed opaque numbered envelopes

Participants

Community‐dwellers and residents of aged‐care facilities discharged from 6 hospitals in Sydney, Australia
Period of study: April 1998 to June 2000
120 participants
Inclusion: people who had completed usual care after a fall‐related hip fracture; consent
Exclusion: unable to complete assessment and participate in exercise programme due to a) severe cognitive impairment, b) medical conditions, or c) complications from fracture resulting in delayed healing and associated weight‐bearing restrictions.
Age: mean 79 years (range 57 to 95 years)
% male: 20
Number lost to follow‐up: 12 (7 withdrew consent ‐ refused assessment; 5 died)

Interventions

All participants had a preliminary assessment which took place, on average, 22 weeks after their injury.
1. Home‐based, weight‐bearing exercises (weight‐bearing position with support as required). Exercises were sit‐to‐stand, lateral step‐up, forward step‐up‐and‐over, forward foot taps, and a stepping grid. Exercises initially conducted with tables, chairs or walking aids used for support. Exercises progressed by increasing the number of repetitions, lessening the hand support, increasing the height of blocks, decreasing height of surface from which the participant was standing up, etc.
versus
2. Home‐based, non‐weight‐bearing exercises (performed in the supine position) prescribed by a physiotherapist. Exercises were hip abduction, hip flexion, hip/knee flexion/extension, end of range knee extension, ankle dorsiflexion/plantarflexion. Exercises were progressed by increasing the number of repetitions undertaken.
versus
3. Control (no specific instructions)

For both exercise groups, the prescribing physiotherapist chose several initial exercises and number of repetitions in keeping with the participant's capability. Individuals in the weight‐bearing group were provided with stepping block(s). Participants were advised on progression. Line drawings of the exercises were provided and they were checked at 1 week. Further assessment and prescription at 1 and 4 months. Participants also asked to keep a record of their exercises.

Exercises were prescribed for 4 months minimum. Advice for exercises etc. given to each participant as deemed appropriate by the physiotherapist conducting final assessment at 4 months.

Outcomes

Length of follow‐up: 4 months

Walking ability/mobility
Gait: walking velocity, step length
Strength: hip abduction and flexion and knee extension
Balance: step test, sway and functional reach
Functional performance measures: timed sit‐to‐stand, supine‐to‐sit and Physical Performance and Mobility Examination
Mortality
Subjectively‐assessed: risk of falling, balance, pain, sleep quality, health
Compliance and assessment of exercises (intervention groups only)
Falls

Notes

Trial was performed as part of Cathie Sherrington's PhD work

Additional information, including binary data for mobility and subjective outcomes, received 09 February 2004.

Funding: Health Research Foundation Sydney South West, Arthritis Foundation of Australia, and National Health and Medical Research Council Partnership in Injury Grant.

Conflict of interest: nil

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"The randomization schedule was produced with a random number table, with subjects being randomized to groups in blocks of 6."

Allocation concealment (selection bias)

Low risk

"..subjects were allocated to groups using assignments sealed in opaque envelopes." Clarification of method by personal communication: "Group allocation enclosed in sealed opaque envelopes which were numbered by subject number which was allocated when the consent form was signed."

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, some judgement

High risk

Assessors were not blinded. However, there was training with the aim of standardisation between the 3 testers.

Blinding of outcome assessment (detection bias)
Observer‐reported outcomes, no judgement

Unclear risk

Not blinded. Unlikely to be affected by the lack of blinding.

Blinding of outcome assessment (detection bias)
Participant/proxy‐reported outcomes

High risk

Assessors were not blinded

Incomplete outcome data (attrition bias)
Observer‐reported outcomes, some judgement

Low risk

Intention‐to‐treat analysis was done and a participant flow diagram provided. Though percentages were presented in the trial report, full data were provided by contact with the lead trialist.

Incomplete outcome data (attrition bias)
Death, re‐admission, re‐operation, surgical complications, return to living at home

Low risk

Intention‐to‐treat analysis was done and a participant flow diagram provided

Incomplete outcome data (attrition bias)
Participant/proxy‐reported outcomes

Low risk

Intention‐to‐treat analysis was done and a participant flow diagram provided. Though percentages were presented in the trial report, full data were provided by contact with the lead trialist.