Methods

• Study design: RCT participant level randomisation

• Study location (WHO income taxonomy): Sheffield, UK (high)

• Funding source: Sheffield Hallam University

• Inclusion criteria: patients who had histologically confirmed colon cancer (Dukes stages A to C) resected 6 to 24 months previously

• Exclusion criteria: existing participation in regular physical activity (purposeful activity of at least moderate intensity of 30 minutes or longer, three times a week), a Karnofsky rating of less than 80, unstable angina, uncontrolled hypertension, recent myocardial infarction or a pacemaker

• CONSORT diagram included: yes

• Number of participants in each arm: 9 intervention, 9 control

• Trial recruitment rate: 18/180

• Length of follow‐up: length of intervention = 12 weeks, length of follow‐up from baseline = 12 weeks

Participants

• Primary cancer diagnosis: histologically confirmed colon cancer (Dukes stages A to C)

• Current cancer treatment: none

• Metastatic disease: none

• Age, years: mean (SD) = control: 70.3 (8.7), intervention: 67.9 (5.7)

• Sex: 12 males, 6 females

• BMI: mean (SD): control: 26.0 (3.5), intervention: 26.9 (3.8)

• Ethnicity: unclear

• Comorbidities reported: unclear

Interventions

• Group or individual intervention: group

• Setting: university rehabilitation suite

• Exercise prescription components: aerobic and resistance

• Theoretical basis: not stated

• CALO‐RE taxonomy components: #15, #16, #26, #27

• Frequency of contact with researchers or exercise professionals: 18 supervised exercise sessions

• Instructions to controls: continue behaviour as normal

Outcomes

• Change in fitness reported: aerobic－exercise tolerance using the Borg treadmill protocol. Resistance－maximal voluntary torque of the knee extensors using isokinetic dynamometry

• Free living energy expenditure: unclear

Process measures

• Method of measuring exercise behaviour: attendance at supervised session with HR monitors, exercise diaries and Godin LSI at assessment points

• Aerobic exercise frequency: three or more times per week

• Aerobic exercise duration: 30 minutes per session or longer

• Aerobic exercise intensity: intensity of 55% to 85% of age‐predicted maximum heart rate and/or ratings of perceived exertion, 11 to 15/fairly light to hard, on the Borg Rating Perceived Exertion (RPE) Scale

• Description aerobic exercise mode: cycle/rowing ergometers, treadmill work. Plus brisk walking, cycling or gym exercise, etc, during independent exercise sessions

• Resistance exercise frequency: three or more times per week

• Resistance exercise sets: between 2 and 4 sets of resistance exercises

• Resistance exercise repetitions: 8 to 12 repetitions

• Resistance exercise intensity: 60% of 1 repetition max

• Description of resistance exercise: Large skeletal muscle groups (quadriceps, deltoids, pectorals, latissimus dorsi, hamstring muscles) were targeted using body weight resistance and free weights

Compliance

• Intervention uptake: 9/9

• Adherence: Attendance was 146 of 162 of the supervised sessions attended (90% compliance). The median (range) rating of perceived exertion (Borg RPE scale) during the exercise sessions was 12 (7 to 16). On average, 94% of the independent exercise sessions (i.e. participants reporting at least 25 to 30 minutes of aerobic exercise) were completed

• Attrition: One participant in the intervention arm was lost to follow‐up. 89% completed final follow‐up in the intervention arm

• Adverse effects: One stroke in the intervention group occurred but was deemed unrelated to the study

• Achieves Rock et al guidelines: six weeks of resistance training

Description of usual care

Both groups had access to standard care, which consisted of a holistic nurse‐led colorectal cancer follow‐up service

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Participants were randomly assigned by an independent researcher via code numbers using nQuery statistical software

Allocation concealment (selection bias)

Low risk

Randomization was undertaken by a senior academic who was not directly involved in the recruitment or assessment of participants

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

All outcomes were assessed by an experienced exercise physiologist, who was blind to the group allocation

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Intention‐to‐treat analysis was used to compare participants in the groups to which they were randomly assigned, with data carried over from previous visits in
cases of participant withdrawal

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

Unclear risk

Low recruitment rate (18/180) could represent a biased sample

Methods

• Study design: RCT participant level randomisation

• Study location (WHO income taxonomy): Sheffield, UK (high)

• Funding source: Sheffield Hallam University

• Inclusion criteria: sedentary men with histologically confirmed, non‐localised prostate cancer who had been receiving AST for at least six months

• Exclusion criteria: those with unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers and painful or unstable bony metastases, and those already undertaking regular physical activity (men engaging in purposeful exercise or physical activity of at least moderate intensity for 30 minutes or longer, three times per week), were excluded

• CONSORT diagram included: yes

• Number of participants in each arm: 25 intervention, 25 control

• Trial recruitment rate: 50/78

• Length of follow‐up: length of intervention = 12 weeks, length of follow‐up from baseline = 6 months

Participants

• Primary cancer diagnosis: prostate cancer T3/T4

• Current cancer treatment: undergoing androgen suppression therapy for a minimum of six months before

• Metastatic disease: yes

• Age, years, mean (SD): control: 72.2 (7.7), intervention: 71.3 (6.4)

• Sex: male

• BMI: mean (SD): control: 27.4 (2.7), intervention: 28.0 (3.2)

• Ethnicity: 100% white

• Comorbidities reported: unclear

Interventions

• Group or individual intervention: group

• Setting: university rehabilitation suite

• Exercise prescription components: aerobic and resistance

• Theoretical basis: not stated

• CALO‐RE taxonomy components: #8, #15, #16, #21, #26, #27

• Frequency of contact with researchers or exercise professionals: 18 supervised exercise sessions

• Instructions given to controls: Men were asked to continue their current exercise/dietary behaviours as normal

Outcomes

• Change in fitness reported: aerobic－exercise tolerance using the Borg treadmill protocol; resistance－maximal voluntary torque of the knee extensors using isokinetic dynamometry

• Free living energy expenditure: unclear

Process measures

• Method of measuring exercise behaviour: attendance at supervised sessions with heart rate monitors, exercise diaries and Godin LSI questionnaire

• Aerobic exercise frequency: three or more times per week

• Aerobic exercise duration: 30 minutes or longer per session

• Aerobic exercise intensity: intensity of 55% to 85% of age‐predicted maximum heart rate and/or ratings of perceived exertion, 11 to 15/fairly light to hard, on the Borg Rating of Perceived Exertion (RPE) Scale

• Description of aerobic exercise mode: cycle/rowing ergometers, treadmill work. Plus brisk walking, cycling and gym exercise

• Resistance exercise frequency: three or more times per week

• Resistance exercise sets: between 2 and 4 sets of resistance exercises

• Resistance exercise repetitions: 8 to 12 repetitions

• Resistance exercise intensity: 60% 1 RM

• Description of resistance exercise: body weight resistance and free weights targeting large skeletal muscle groups

Compliance

• Intervention uptake: 25/25

• Adherence: Attendance at the supervised exercise sessions was 360 of 378 sessions (95%). Compliance with the self‐directed exercise aspect of the lifestyle intervention was also very good, with 329 of 378 sessions (87%) completed (i.e. participants reporting in their log books at least 25 to 30 minutes of aerobic exercise)

• Attrition: Four men in the intervention gap at 12 weeks and three men in the control group at 12 weeks were lost to follow‐up. 10 men in the intervention group failed to complete six‐month follow‐up, 12 men in the control group failed to complete six‐month follow‐up. Overall, 84% and 60% of the intervention arm completed three and six months of follow‐up

• Adverse effects: Two men in the intervention arm were discontinued because of cardiac complications before the 12‐week assessments. Two more reported musculoskeletal complaints before the six‐month assessment. Five men in the control group reported various health problems that prohibited them from attending the six‐month assessment

• Achieves Rock et al guidelines: 6 weeks of resistance training

Description of usual care

Men randomly assigned to standard care were followed up in the urology clinic as normal and were seen by an oncology nurse specialist and a urologist

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomization was carried out remotely, using nQuery statistical software (nQuery Advisor 6.01; Statistical Solutions)

Allocation concealment (selection bias)

Low risk

Randomization was undertaken by a senior academic who was not directly involved in the recruitment or assessment of participants

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Physiological and functional fitness outcomes were assessed by a trained technician blinded to group allocation. Responses on the self‐administered questionnaires were checked for completeness by the researcher in the presence of the respondent

Incomplete outcome data (attrition bias)
All outcomes

High risk

44% attrition at six‐month postintervention follow‐up

Selective reporting (reporting bias)

Low risk

None; all outcomes reported

Other bias

Low risk

None

Methods

• Study design: RCT participant level randomisation

• Study location (WHO income taxonomy): US, Connecticut (high)

• Funding source: supported in part by a General Clinical Research Center grant from the National Center of Research Resources, National Institutes of Health (Grant # M01‐RR00125) awarded to Yale University School of Medicine

• Inclusion criteria: postmenopausal women, aged 40 to 75 years, AJCC Stages 0 to IIIa breast cancer, 1 to 10 years postdiagnosis, > 12 months postcompletion of adjuvant treatment, physically able to exercise with physician consent to begin an exercise programme, sedentary activity pattern (< 60 min/wk) with physician consent to begin an exercise programme

• Exclusion criteria: diagnosis of recurrent or other primary cancer event. Current smoker, diabetes mellitus, current or planned enrolment in a structured weight loss programme

• CONSORT diagram included: yes, in Irwin 2008

• Number of participants in each arm: 37 intervention, 38 control

• Trial recruitment rate: 75/88

• Length of follow‐up: length of intervention = 6 months, length of follow‐up from baseline = 6 months

Participants

• Primary cancer diagnosis: AJCC Stages 0 to IIIa breast cancer

• Current cancer treatment: completed adjuvant treatment (with the exception of hormonal therapy) at least six months before enrolment. 57% versus 70% on hormone therapy in the intervention group versus controls; 30% on tamoxifen in both arms; 27 versus 40% versus control on aromatase inhibitors

• Metastatic disease: none

• Age, years: mean (SD): intervention: 56.5 (9.5), control: 55.1 (7.7)

• Sex: women

• BMI: mean (SD): intervention: 30.4 (6.0), control: 30.1 (7.4)

• Ethnicity: 84% white in both groups

• Comorbidities reported: unclear

Interventions

• Group or individual intervention: supervised and home based

• Setting: a supervised training programme at a local health club. Participants exercised at the club during designated sessions

• Exercise prescription components: aerobic training

• Theoretical basis: not stated

• CALO‐RE taxonomy components: #1, #5, #8. #9, #15, #16, #17, #19, #21, #26, #29, #35

• Frequency of contact with researchers or exercise professionals: unclear exactly how many exercise sessions were supervised

• Instructions to controls: Participants assigned to the usual care groups were told that they could exercise on their own if they chose, but that the study’s physical activity programme would not be available to them. They received all exercise programme materials at six‐month follow‐up

Outcomes

• Change in fitness reported: not reported

• Free living energy expenditure: unclear

Process measures

• Method of measuring exercise behaviour: heart rate monitors, physical activity questionnaire, a seven‐day physical activity log and a seven‐day pedometer log. Adherence to the intervention among exercise group participants was assessed by seven‐day physical activity logs weekly

• Aerobic exercise frequency: three sessions per week supervised, two sessions per week at home or at a health club: total five days a week

• Aerobic exercise duration: participants were asked to perform three 15‐minute sessions during week 1, building to five 30‐minute moderate intensity sessions by week 5

• Aerobic exercise intensity: 60% to 80% of maximal heart rate reserve

• Description aerobic exercise mode: From Irwin 2008: The intervention consisted primarily of walking, an activity preferred by most women and breast cancer survivors, although participants could choose to meet the exercise goal through swimming, aerobics, other forms of activity or a combination of different activities. Activities that did not involve sustained aerobic effort, such as weight lifting and yoga, could be performed but did not count toward the exercise goal for each week

• Resistance exercise frequency: N/A

• Resistance exercise sets: N/A

• Resistance exercise repetitions: N/A

• Resistance exercise intensity: N/A

• Description of resistance exercise: N/A

Compliance

• Intervention uptake: 37/37

Adherence:

• Cadmus 2009: Regarding the weekly goals of thrice‐weekly supervised exercise sessions at the health club and twice‐weekly unsupervised sessions on their own, women participated in 67% of the supervised exercise sessions, and 96% of women reported exercising on their own two other days of the week and exercised on average at 76% of their maximal heart rate (82% as a mean over both supervised and unsupervised)

• Irwin 2008: 33% reported 150 minutes/wk of aerobic exercise at an average of 76% HR over the six‐month intervention. Women randomly assigned to exercise chose weight‐bearing activities most often, with 82% walking. Few women reported doing resistance training (3%). 75% of women were doing between 90 and 119 minutes of moderate intensity exercise per week, over six months

• Latka 2009: The variables that predict adherence were BMI and transtheoretical model stage of change. Specifically, a lower BMI and a higher degree of readiness to change physical activity behavior were associated with better adherence

• Attrition: 6 of 75 in total. One participant lost to follow‐up in the intervention group, five lost to follow‐up in the control group. 97% completed final follow‐up in the intervention group

• Adverse effects: five of the 37 women randomly assigned to exercise experienced an adverse effect; two were related to the study (plantar fascitis), and three were unrelated (swollen Achilles, stress fracture in foot and plantar fasciitis) to the study. No women developed lymphedema during the study

• Achieves Rock et al guidelines: 33% reported 150 minutes/wk of moderate intensity aerobic exercise at an average of 76% HR for six months

Description of usual care

Unclear

Notes

Only YES trial included in the review because of the requirement that participants must be sedentary at baseline

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

A computer programme randomly assigned each YES study participant with equal probability to the exercise group or the usual care group

Allocation concealment (selection bias)

Low risk

The randomisation code for each participant was obtained by the principal investigator (who was not involved in recruitment or data collection) only after baseline measures for that individual had been completed and staff conducting clinic visits did not have access to the randomisation programme

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Analyses were conducted according to the intention‐to‐treat principle. Baseline QOL values were carried forward for the five IMPACT study participants (three exercisers and two controls) and 10 YES study participants (five exercisers and five controls) for whom six‐month data were unavailable

Selective reporting (reporting bias)

Low risk

None, all outcomes reported

Other bias

Low risk

None

Methods

• Study design: RCT individual participant level randomisation

• Study location (WHO income taxonomy): Sheffield, UK (high)

• Funding source: supported by Grant No. CE8304 from Cancer Research UK

• Inclusion criteria: Women who were not regularly active (up to 2 × 20 minute sessions a week at moderate intensity (researcher had to gauge with client whether it was moderate intensity－fairly light to somewhat hard) RPE 11 to 13 were used); exercise "pre‐contemplators", "contemplators" or "preparers" as defined by the transtheoretical model, who had been treated for localised breast cancer 12 to 36 months previously, were eligible

• Exclusion criteria: Women with metastases and inoperable or active locoregional disease were ineligible (clinician determined)

• CONSORT diagram included: yes

• Number of participants in each arm: 34; 36; 38 (intervention; sham; control, respectively)

• Trial recruitment rate: 108/273

• Length of follow‐up: length of intervention = 8 weeks, length of follow‐up from baseline = 24 weeks

Participants

• Primary cancer diagnosis: breast cancer survivors without metastases (inoperable or active locoregional disease) were ineligible

• Current cancer treatment: 73.5%, 69.4% and 76.3% using hormone therapy in the intervention, placebo and usual care groups, respectively

• Metastatic disease: none

• Age, years, mean (SD): 51.6 (8.8); 50.6 (8.7); 51.1 (8.6) (intervention; sham; control, respectively)

• Gender: women

• BMI: mean (SD): 28.5 (4.4); 27.6 (4.1); 29.6 (5.1) (intervention; sham; control, respectively)

• Ethnicity: two of 108 non‐white

• Comorbidities reported: 45/108 had lymphoedema

Interventions

• Group or individual intervention: one‐to‐one supervised sessions

• Setting: university rehabilitation suite

• Exercise prescription components: aerobic

• Theoretical basis: transtheoretical model

• CALO‐RE taxonomy components: #1, #5, #8, #9, #10, #13, #16, #17, #18, #20, #21, #23, #26, #29, #35

• Frequency of contact with researchers or exercise professionals: Every exercise session was supervised

• Instructions to controls: The usual‐care group continued with their lives as usual. The exercise‐placebo group attended 24 one‐to‐one 50‐minute sessions during 8 weeks; however, instead of aerobic exercise, they performed light‐intensity body conditioning/stretching (e.g. flexibility, passive stretching) exercises, during which HR was maintained below 40% heart rate reserve (HR typically was kept below 100 beats per minute). No exercise counselling or behavioral change advice was provided; instead, conversations were entered on topics of everyday life (i.e. weather, news items, and families). HR and RPE were assessed every 5 minutes

Outcomes

• Change in fitness reported: Aerobic exercise tolerance was measured using the submaximal, 8‐minute, single‐stage walking test performed on a treadmill

• Free living energy expenditure: unclear

Process measures

• Method of measuring exercise behaviour: Adherence was calculated from session attendance, and the amount (duration, RPE, HR) of exercise achieved by participants during sessions was calculated by abstraction from physical activity logs maintained by the researcher

• Aerobic exercise frequency: three sessions per week

• Aerobic exercise duration: 27 minutes of exercise on average per session

• Aerobic exercise intensity: 65% to 85% of age‐adjusted HR maximum and RPE of 12 to 13

• Description aerobic exercise mode: treadmills, rowing ergometers and cycling ergometers

• Resistance exercise frequency: N/A

• Resistance exercise sets: N/A

• Resistance exercise repetitions: N/A

• Resistance exercise intensity: N/A

• Description of resistance exercise: N/A

Compliance

• Intervention uptake: 34/34

• Adherence: Adherence to the interventions was excellent; 77% of exercise therapy and 88.9% of exercise‐placebo groups, respectively, attended 70% (at least 17 of 24 sessions) or more of sessions. Mean HR for the exercise therapy group ranged from 117.4 (SD, 12.9) to 121.5 (SD, 13.4) throughout the weeks. Mean HR for exercise‐placebo ranged from 92.5 (SD, 13.2) to 95.9 (SD, 9.5). Average durations of aerobic exercise achieved by exercise therapy ranged from 25.7 (SD, 6.3) to 27.4 (SD, 6.2) minutes. HR data indicated that both groups were exercising in accordance with the protocol

• Attrition: at 8 weeks, 1 ,0 and 5 women were lost to follow‐up in the intervention, sham and control groups, respectively. At 24 weeks, 3, 2 and 7 women were lost to follow‐up in the intervention, sham and control groups, respectively

• Adverse effects: three withdrawals in the intervention group: unclear as to why this occurred. Some withdrawals due to medical complications in placebo and control arms, but unclear if study related

• Achieves Rock et al guidelines: no

Description of usual care

All participants continue to receive usual care from their health team

Notes

Mean and SD data for aerobic exercise tolerance at 8 and 24 weeks provided by authors in response to email request

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

A telephone randomisation service was provided by an independent trials unit. Randomisation to the three treatment arms was done on a 1:1:1 ratio and was performed using stratified random permuted blocks (with block size of six). Stratification factors were chemotherapy (yes/no) and tamoxifen (yes/no)

Allocation concealment (selection bias)

Low risk

Randomisation service was provided by an independent trials unit telephone service

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Outcome assessors were not blinded to participants’ group allocation

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Little’s D test indicated that missing data were missing completely at random (2 88.2; df 1290; P = 0.99). Data were analysed on an intention‐to‐treat basis

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

Low risk

None

Methods

• Study design: RCT individual participant level randomisation

• Study location (WHO income taxonomy): US, Michigan (high)

• Funding source: This study was funded by grants from the Elsa U. Pardee Foundation in Midland, Michigan, and the Max and Victoria Dreyfus Foundation in White Plains, New York

• Inclusion criteria: sedentary females (less than 30 minutes of moderate intensity exercise three times per week), between 20 and 65 years of age, with histologically established Stage 0 (ductal carcinoma in situ) to III breast cancer, with medical clearance and signed informed consent

• Exclusion criteria: uncontrolled cardiac or hypertensive disease, orthopaedic conditions that would limit exercise participation, refusal to accept randomisation or participation in aerobic exercise within three months before the start of the study. Medical clearance for this study was determined by the participant’s oncologist, the results of a routine Multiple Uptake Gated Scan (MUGA) of heart function and a symptom limited graded exercise test

• CONSORT diagram included: no

• Number of participants in each arm: 13 intervention, 8 placebo stretching controls

• Trial recruitment rate: 23/39

• Length of follow‐up: length of intervention = 8 weeks, length of follow‐up from baseline = 8 weeks

Participants

• Primary cancer diagnosis: Stage 0 (ductal carcinoma in situ) to III breast cancer

• Current cancer treatment: Each participant was undergoing external beam radiation five days per week for seven weeks. The affected breast and regional lymph nodes received a 4500 to 5000 cGy dose in 200 cGy fractions with a boost of 1000 to 1600 cGy delivered to the primary tumour bed. Treatment dosages were similar between groups

• Metastatic disease: no

• Age, years: mean (SD): intervention: 49.4 (7.0), controls: 51.9 (10.0)

• Sex: women

• BMI: unclear

• Ethnicity: 13 African American, 8 Caucasian

• Comorbidities reported: not clear

Interventions

• Group or individual intervention: unsupervised－members of the aerobic exercise group were instructed to perform self‐monitored walking in their neighbourhood or on a treadmill in their home

• Setting: home‐based

• Exercise prescription components: aerobic

• Theoretical basis: not stated

• CALO‐RE taxonomy components: #16, #17, #21, #26

• Frequency of contact with researchers or exercise professionals: weekly phone calls with researcher

• Instructions to controls: Participants in the placebo stretching group were instructed to perform a general stretching protocol three to five days per week during this same period. However, the control group was told not to begin any new exercise activity other than a general flexibility programme that they were given

Outcomes

• Change in fitness reported: VO₂ peak assessed before and after intervention

• Free living energy expenditure: unclear

Process measures

• Method of measuring exercise behaviour: All participants were provided a training diary to record their training adherence in days per week and minutes per day; members of the intervention group also recorded their training heart rate range. The principal investigator communicated with all participants weekly in person or by telephone. Participants in the intervention group wore heart rate monitors to record training time and time spent in the training heart rate range to improve reporting of data on exercise compliance, training intensity and training duration

• Aerobic exercise frequency: three to five times per week

• Aerobic exercise duration: 20 to 45 minutes

• Aerobic exercise intensity: Exercise intensity was 50% to 70% of the maximal heart rate achieved by the participant during a symptom limited graded exercise test

• Description aerobic exercise mode: self‐monitored walking in the neighbourhood or on a treadmill in the home

• Resistance exercise frequency: N/A

• Resistance exercise sets: N/A

• Resistance exercise repetitions: N/A

• Resistance exercise intensity: N/A

• Description of resistance exercise: N/A

Compliance

• Intervention uptake: 13/13

• Adherence: Participants in the intervention group averaged 3.6 days per week of aerobic exercise over an 8‐week period, and placebo stretching subjects averaged 3.9 days per week of participation during this same time period. No details are available on what "participation" for the placebo stretching group constituted

• Attrition: Two women were lost to follow‐up in the placebo stretching arm. Data from one participant in the placebo stretching group were eliminated from the final analysis because of marked irregularities in pretest and post‐test physical measures from moderate to severe fluid retention during the initial test session

• Adverse effects: none reported

• Achieves Rock et al guidelines: unclear

Description of usual care

Each participant was treated with external beam radiation five days per week for seven weeks. The affected breast and regional lymph nodes received a 4500 to 5000 cGy dose in 200c Gy fractions with a boost of 1000 to 1600 cGy delivered to the primary tumour bed. Treatment dosages were similar between groups

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

A random number table was used

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Incomplete outcome data (attrition bias)
All outcomes

Low risk

2 of 23 participants lost to follow‐up

Selective reporting (reporting bias)

Low risk

None

Other bias

Low risk

None

Methods

• Study design: RCT individual participant level randomisation

• Study location (WHO income taxonomy): Austrailia (high)

• Funding source: National Breast Cancer Foundation for funding Dr. Hayes’ fellowship

• Inclusion criteria: women younger than 76 years, who had completed treatment for unilateral breast cancer at least six months before, subsequently had unilateral upper limb lymphoedema diagnosed by a healthcare professional and were prepared to travel to the exercise clinic for 12 weeks (if randomly allocated to the intervention group (IG)) were eligible. All participants were doing < 90 minutes/wk of moderate intensity exercise (intensity was assessed by RPE)

• Exclusion criteria: no other exclusion criteria were applied

• CONSORT diagram included: no

• Number of participants in each arm: 16 intervention, 16 control

• Trial recruitment rate: 32/138

• Length of follow‐up: length of intervention = 12 weeks, length of follow‐up from baseline = 24 weeks

Participants

• Primary cancer diagnosis: unilateral breast cancer

• Current cancer treatment: none

• Metastatic disease: no

• Age, years: mean (SD): control: 60 (11), intervention 59 (7)

• Sex: women

• BMI: unclear

• Ethnicity: unclear

• Comorbidities reported: all had lymphoedema

Interventions

• Group or individual intervention: a mix of supervised and non‐supervised. Supervised sessions were group based (up to 10 women)

  • Weeks 1 to 4: three times per week (two supervised)

  • Weeks 5 to 8: four times per week (two supervised)

  • Weeks 9 to 12: at least four times per week (one supervised)

• Setting: unclear

• Exercise prescription components

  • Weeks 1 to 2: aerobic only (floor‐based aerobic exercise to music and walking)

  • Weeks 3 to 4: aerobic (floor‐based aerobic exercise to music, water‐based aerobic exercise and walking) and water‐based resistance exercises

  • Weeks 5 to 8: aerobic (mix of all types) and water‐based and free‐weight resistance exercises

  • Weeks 9 to 12: aerobic (mix of all types) and machine‐weight resistance exercise

• Theoretical basis: not stated

• CALO‐RE taxonomy components: #9, #26

• Frequency of contact with researchers or exercise professionals: 20 supervised exercise sessions over 12 weeks

• Instructions to controls: The control group was instructed to continue habitual activities

Outcomes

• Change in fitness reported: none

• Free living energy expenditure: unclear

Process measures

• Method of measuring exercise behaviour: Together, exercise adherence rates and qualitative comments were used to provide insight into the acceptability of the programme

• Aerobic exercise frequency: three to four or more times per week

• Aerobic exercise duration: 20 to 45+ minutes

• Aerobic exercise intensity: 3 to 7 on a modified Borg scale

• Description aerobic exercise mode: floor‐based aerobic exercise to music, water‐based aerobic exercise and walking

• Resistance exercise frequency: three to four or more times per week

• Resistance exercise sets: unclear

• Resistance exercise repetitions: 20 to 10

• Resistance exercise intensity: approximately 15 to 10 repetition max

• Description of resistance exercise: unclear

Compliance

• Intervention uptake: 16/16

• Adherence: Most women (88%) allocated to the intervention group participated in 70% or more of scheduled supervised exercise sessions. The intervention was scheduled over winter, and missed sessions were most often related to respiratory illness (n = 10). Other reasons included having a skin lesion removed (n = 1), undergoing gynaecological surgery (n = 1) and having work commitments (n = 2). One participant missed 50% of supervised sessions. Unsupervised exercise adherence is unclear

Qualitative quotes:

• "Without having you to guide me, there is no way I would have ever done the things I’ve done as part of this program"

• "You gave me the confidence to know what I and my arm can do"

• "I would not have tried the things I’ve done if not for the study. I now feel capable of joining an aqua class"

• "You’ve shown me what I can do rather then tell me what I shouldn’t do"

• Attrition: one participant in each group at 24 weeks

• Adverse effects: none reported

• Achieves Rock et al guidelines: unclear

Description of usual care

Physiotherapy, massage, compression, lymphatic drainage or laser therapy for lymphoedema

Notes

Resistance aspect of this intervention will be excluded from analysis because of unclear exercise metrics

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Participants were randomly allocated using a computer‐generated table of random numbers

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

All measures were assessed pre‐intervention (time 1; T1), immediately postintervention (time 2; T2) and at 12‐week follow‐up (time 3; T3) and were conducted by the same assessor, who was blinded to participant group allocation

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All participants (n = 32) participated in T1 and T2, whereas data were unavailable for two participants (one in the IG and one in the CG) at T3. To ensure that missing data did not contribute to the results found, data analysis was repeated with these two participants excluded, and no differences in results were observed (data not shown)

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

High risk

Adherence data on home‐based aspect of the intervention not clear

Methods

• Study design: RCT individual participant level randomisation

• Study location (WHO income taxonomy): Greece (high)

• Funding source: unclear

• Inclusion criteria: participating only in the dancing exercising programme; none of the participants had prior physical practise or experience in traditional Greek dances or were participating in regular moderate intensity exercise. All participants had been diagnosed and surgically treated for breast cancer. They had completed cancer therapies, including surgery, radiotherapy and chemotherapy and had stopped all medical treatments at least three months before the beginning of the study (mean time post‐treatment: 2.2 years)

• Exclusion criteria: included poorly controlled hypertension and any health condition that would deter the participant from performing the exercises

• CONSORT diagram included: no

• Number of participants in each arm: 14, 13 (intervention vs control)

• Trial recruitment rate: unclear

• Length of follow‐up: length of intervention = 24 weeks, length of follow‐up from baseline = 24 weeks

Participants

• Primary cancer diagnosis: All participants had been diagnosed and surgically treated for breast cancer

• Current cancer treatment: Participants had completed cancer therapies, including surgery, radiotherapy and chemotherapy and had stopped all medical treatments at least three months before the beginning of the study (mean time post‐treatment: 2.2 years)

• Metastatic disease: unclear

• Age, years: mean (SD): intervention: 56.6 (4.2), control: 57.1 (4.1)

• Sex: women

• BMI: unclear

• Ethnicity: unclear

• Comorbidities reported: unclear

Interventions

• Group or individual intervention: group

• Setting: supervised

• Exercise prescription components: aerobic training with Greek traditional dances, upper body training and cool‐down

• Theoretical basis: not stated

• CALO‐RE taxonomy components: #9, #21, #22, #26

• Frequency of contact with researchers or exercise professionals: three supervised exercise sessions per week

• Instructions to controls: asked to refrain from any form of recreational activity during the study period

Outcomes

• Change in fitness reported: aerobic exercise tolerance assessed by 6‐minute walk test

• Free living energy expenditure: unclear

Process measures

• Method of measuring exercise behaviour: unclear

• Aerobic exercise frequency: three times per week

• Aerobic exercise duration: the aerobic training phase lasted 25 minutes and included learning and practising Greek traditional dances

• Aerobic exercise intensity: All dances, practised throughout the intervention, were of moderate intensity (between 65% and 80% of maximum heart rate). Heart rate was estimated by palpation by participants for four 15‐sec periods. Participants also rated their perceived exertion on a Borg scale. They were encouraged to reach perceived exertion 13 to 14 on the Borg 6 to 20 category scale. Intensity of exercise was prescribed on an individual basis, and the workload was progressively increased

• Description aerobic exercise mode: Greek traditional dances

• Resistance exercise frequency: three times per week

• Resistance exercise sets: unclear

• Resistance exercise repetitions: unclear

• Resistance exercise intensity: unclear

• Description of resistance exercise: Upper body exercise training and cool‐down lasted 25 minutes and emphasised stretching and resistance training with the use of various resistance machines

Compliance

• Intervention uptake: unclear

• Adherence: unclear

• Attrition: unclear

• Adverse effects: none reported

• Achieves Rock et al guidelines: unclear

Description of usual care

Unclear

Notes

Resistance aspect of this intervention will be excluded from analysis because of unclear exercise metrics

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

High risk

Method of measuring exercise behaviour and adherence not reported

Methods

• Study design: RCT individual participant level randomisation

• Study location (WHO income taxonomy): US (high)

• Funding source: supported by an R01 grant from the National Institutes of Health, National Institute of Nursing Research and a Postdoctoral Fellowship Award from the Korea Science and Engineering Foundation (KOSEF).

• Inclusion criteria: women newly diagnosed with breast cancer; no history of cancer; all stages of breast cancer; age 40 years and above; and receiving cancer treatment

• Exclusion criteria: women with known bony metastasis; high risk of fracture; known psychiatric illness; uncontrolled cardiopulmonary or other serious medical condition; and regular exercise at least two to three times a week of moderate intensity (less than 90 minutes total) within the past two months

• CONSORT diagram included: no

• Number of participants in each arm: 22 intervention,19 control

• Trial recruitment rate: unclear

• Length of follow‐up: length of intervention = 8 weeks, length of follow‐up from baseline = 24 weeks

Participants

• Primary cancer diagnosis: Women with newly diagnosed breast cancer were stratified by the stage of breast cancer (Stages I to IIB vs locally advanced)

• Current cancer treatment: undergoing treatment－chemotherapy was the most common type of adjuvant therapy (48.8%), followed by radiotherapy (34.1%) and a combination of chemotherapy and radiotherapy (17.1%)

• Metastatic disease: none

• Age, years: mean (SD): intervention: 51.3 (6.7), controls: 48.3 (8.8)

• Sex: women

• BMI: unclear; 33 women who had significantly higher BMI (34.3 ± 10.2) excluded from analysis

• Ethnicity: 78% white reported

• Comorbidities reported: unclear

Interventions

• Group or individual intervention: unclear

• Setting: cardiac rehabilitation unit with cardiac monitoring until participants were released to be safe (for n = 2) and an exercise facility within the School of Nursing. Although most participants continued their exercise intervention in this exercise facility, a few opted to exercise at home on their own treadmill or to do fast walking

• Exercise prescription components: aerobic

• Theoretical basis: not stated

• CALO‐RE taxonomy components: #1, #21, #26, #36

• Frequency of contact with researchers or exercise professionals: supervised exercise sessions three times per week for the "majority"

• Instructions to controls: Usual care participants were instructed to refrain from starting a regular or structured exercise programme while participating in the study

Outcomes

• Change in fitness reported: changes in VO₂ peak at baseline at 8 weeks (although it is not clear how VO₂ was measured)

• Free living energy expenditure: estimate of energy expenditure reported

Process measures

• Method of measuring exercise behaviour: frequency, intensity and duration of exercise during the 8‐week intervention period were monitored using Polar HR monitors, which were provided to all participants. All participants in both groups received a seven‐day physical activity log to track their levels of exercise/physical activity over 16 weeks after the eight‐week intervention. The seven‐day physical activity log included five categories of the exercise/physical activity level, ranging from vigorous to sleeping/reclining, with explicit examples given for each level, which made monitoring feasible for participants. During 16 weeks of the postintervention follow‐up period, the exercise physiologist research member called participants regularly to collect exercise/physical activity data from the log biweekly for participants in the intervention group and monthly for participants in the control group. Participants in the control group received less‐frequent calls to minimise unintentional motivation or a reminder for exercise, but data were recorded at 2‐week intervals for both groups

• Aerobic exercise frequency: three days per week

• Aerobic exercise duration: 30 minutes of aerobic exercise and 5 minutes for warm‐up or cool‐down

• Aerobic exercise intensity: moderate intensity to produce an HR corresponding to 60% to 70% of the individual’s HR reserve and/or VO₂ peak achieved on a graded exercise test at baseline

• Description aerobic exercise mode: cycling, walking, jogging or running on a treadmill or track

• Resistance exercise frequency: N/A

• Resistance exercise sets: N/A

• Resistance exercise repetitions: N/A

• Resistance exercise intensity: N/A

• Description of resistance exercise: N/A

Compliance

• Intervention uptake: not clear

• Adherence: Average weekly frequency of exercise was 2.4 ± 0.6 sessions, and average duration of exercise was 42.7 ± 8.0 minutes per session, including warm‐up and cool‐down periods. Average duration of exercise within prescribed target HRs was 27.8 ± 8.1 minutes per session. Overall adherence to exercise intervention was 78.3% ± 20.1%, but week‐to‐week variations over the 8‐week intervention period ranged from 68.3% at week 7 to 95.0% at week 3

• Attrition: Of 74 women recruited, 11 women (6 control, 5 intervention) withdrew from the study. Reasons for withdrawal included personal problems (n = 2), problems at home (n = 2), problems related to chemotherapy (n = 3), thrombophlebitis in the lower leg (n = 2), non－exercise‐related injuries (n = 1) and death (n = 1). Twenty‐two women (12 control and 10 intervention) missed either a pre‐intervention or a postintervention graded exercise test (GXT), mainly because of scheduling conflicts, not keeping GXT appointments more than twice or unwillingness to perform the GXT. Forty‐one women completed both pre‐intervention and postintervention GXTs (i.e. 41/74)

• Adverse effects: see above

• Achieves Rock et al guidelines: no

Description of usual care

Usual cancer care included general information on the benefits of exercise but did not include specific instructions or further guidance for exercise. Seventy‐eight per cent of women had Stage I and Stage II breast cancer, and chemotherapy was the most common type of adjuvant therapy (48.8%), followed by radiotherapy (34.1%) and a combination of chemotherapy and radiotherapy (17.1%). Regimens of adjuvant therapy most often consisted of adriamycin 60 mg/m² and cytoxan 600 mg/m² every 2 to 3 weeks for 3
doses with or without Taxol 145 mg/m² every 2 to 3 weeks for 3 to 4 doses. Radiotherapy was typically composed of delivering a total of 45 to 65 Gy over 6 to 7 weeks with
booster doses of 20 Gy

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomisation

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Incomplete outcome data (attrition bias)
All outcomes

High risk

Data on only 41 of 74 randomly assigned participants reported

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

High risk

Women randomly assigned but excluded had higher BMI and more advanced stages of cancer

Methods

• Study design: RCT individual participant level randomisation

• Study location (WHO income taxonomy): Canada (high)

• Funding source: supported by the Canadian Breast Cancer Research Initiative

• Inclusion criteria: Participants were eligible for the study if they had undergone breast cancer treatment for Stage I or II breast cancer that had been completed more than six months before enrolling in the study and had subsequently developed unilateral lymphoedema that was greater than 2 cm and less than 8 cm on at least one measurement point. Participants were not participating in > 90 minutes per week of moderate intensity exercise

• Exclusion criteria: Stage III lymphoedema, bilateral disease or cases for which medication was required that might affect upper extremity swelling

• CONSORT diagram included: no

• Number of participants in each arm: 7 intervention, 7 control

• Trial recruitment rate: unclear

• Length of follow‐up: length of intervention = 8 weeks, length of follow‐up from baseline = 8 weeks

Participants

• Primary cancer diagnosis: Stage I or II breast cancer

• Current cancer treatment: All completed treatment six months before starting the trial

• Metastatic disease: no

• Age, years: mean (SD): intervention: 56.4 (10.4), control: 56.9 (8.2)

• Sex: women

• BMI: mean (SD): intervention: 29.1 (6.6), control: 25.6 (3.3)

• Ethnicity: unclear

• Comorbidities reported: unclear

Interventions

• Group or individual intervention: unclear

• Setting: supervised

• Exercise prescription components: aerobic and resistance

• Theoretical basis: not stated

• CALO‐RE taxonomy components: #9, #26

• Frequency of contact with researchers or exercise professionals: supervised exercise sessions three times per week

• Instructions to controls: Control participants were given no specific exercise instruction until after they completed the study but were specifically asked to refrain from initiating any new activity

Outcomes

• Change in fitness reported: no

• Free living energy expenditure: unclear

Process measures

• Method of measuring exercise behaviour: Work in kilojoules was calculated for each session for every participant, and this was used to calculate cumulative work done over the course of the programme

• Aerobic exercise frequency: three days per week (initiated after week 2)

• Aerobic exercise duration: 5 to 20 minutes

• Aerobic exercise intensity: arm cycling at a resistance of 8.3 W to 25 W. Intensity was also assessed with Polar HR monitors. Target HR was 60% to 80% of maximum predicted by age

• Description aerobic exercise mode: arm cycling

• Resistance exercise frequency: three days per week

• Resistance exercise sets: two sets of 10 repetitions for each exercise were done for the first week, three sets of 10 were done thereafter

• Resistance exercise repetitions: See above

• Resistance exercise intensity: unclear

• Description of resistance exercise: seated row, bench press, latissimus dorsi pull‐down, one arm bent‐over rowing, tricep extension, and bicep curl

Compliance

• Intervention uptake: unclear

• Adherence: unclear

• Attrition: no attrition reported

• Adverse effects: none reported

• Achieves Rock et al guidelines: no

Description of usual care

Unclear

Notes

Resistance aspect of this intervention will be excluded from analysis because of unclear exercise metrics

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

High risk

Adherence to prescribed exercise not reported

Methods

• Study design: RCT individual participant level randomisation

• Study location (WHO income taxonomy): New Jersey, USA (high)

• Funding source: supported by an award from the Greater NYC Affiliate of the Susan G. Komen Breast Cancer Foundation, Inc., New York, NY

• Inclusion criteria: Eligible survivors were English‐speaking women diagnosed with Stage I to IIIB breast cancer who had completed adjuvant chemotherapy at least three months or radiation therapy at least 6 weeks before entry, and who were no more than 24 months beyond their last treatment. Hormonal therapy could be ongoing

• Exclusion criteria: Women were excluded if medical history or physical examination revealed evidence of anaemia (haemoglobin <10 mg/dL), uncontrolled hypertension, congestive heart failure, pulmonary disease, diabetes and thyroid or musculoskeletal disease. Additional exclusion criteria included current enrolment in a weight loss or exercise programme or a positive response to any question on the Physical Activity Readiness Questionnaire, thus indicating the need for medical clearance before starting an exercise programme

• CONSORT diagram included: no

• Number of participants in each arm: flexibility group (n = 13), aerobic group (n = 12), resistance group (n = 17), aerobic and resistance group (n = 13). Overall N = 55

• Trial recruitment rate: 55/231

• Length of follow‐up: length of intervention = 12 weeks, length of follow‐up from baseline = 12 weeks

Participants

• Primary cancer diagnosis: completed adjuvant chemotherapy at least three months or radiation therapy at least six weeks before entry and were no more than 24 months beyond their last treatment

• Current cancer treatment: hormonal therapy could be ongoing: 56% on hormone therapy

• Metastatic disease: none

• Age: overall mean (SD) = 50.5 (7.5)

• Sex: women

• BMI: unclear

• Ethnicity: unclear

• Comorbidities reported: unclear

Interventions

• Group or supervised intervention: individual

• Setting: home based

• Exercise prescription components: aerobic and resistance exercise

• Theoretical basis: exercise and self‐esteem model

• CALO‐RE taxonomy components: #9, #16, #17, #21, #22, #26

• Frequency of contact with researchers or exercise professionals: weekly contact via phone or e‐mail. Content included exercise programme adherence, the need for progression of the exercise prescription and adverse effect reporting

• Instructions to controls: All participants were prescribed flexibility exercise. In‐person verbal instruction plus demonstration was used to teach participants how to do their assigned exercises. In addition, each participant received a written guidebook that included general information about exercise participation, such as clothing and safety tips, as well as their individualised exercise prescription, exercise instructions and an exercise log sheet

Outcomes

• Change in fitness reported: prediction of VO₂ max from submaximal treadmill testing using the Bruce protocol; change in upper body weight lifted and endurance reported

• Free living energy expenditure: unclear

Process measures

• Method of measuring exercise behaviour: Adherence to the exercise prescription was calculated as a proportion of completed sessions over the total possible number of sessions in the assigned exercise programme. Mean percentage scores were as follows: flexibility = 85, aerobic = 81, resistance = 91 and aerobic plus resistance = 86. Although participants were encouraged to complete their exercise log, only 50% of participants successfully did so

• Aerobic exercise frequency: three times per week. Women who participated in the aerobic and resistance group followed instructions similar to those given to the aerobic and resistance only groups; however, the frequency of aerobic exercise progressed to four to five days per week, and resistance was maintained at two times per week

• Aerobic exercise duration: 15 to 30 minutes

• Aerobic exercise intensity: 40% to 65% of the calculated heart rate max

• Description aerobic exercise mode: walking

• Resistance exercise frequency: times per week. A+R group performed resistance exercise twice per week

• Resistance exercise sets: one

• Resistance exercise repetitions: Women started with one set of 10 to 12 repetitions. Progression through more resistive bands occurred so that RPE rose to around seven to eight at the completion of 12 repetitions

• Resistance exercise intensity: Women in the resistance group were prescribed a Thera‐Band that produced an RPE of 3 to 5 on a scale of 0 to 10. Progression through more resistive bands occurred so that RPE rose to around seven to eight at the completion of 12 repetitions

• Description of resistance exercise: Women started with one set of 10 to 12 repetitions of the following exercises: shoulder flexion, shoulder press, latissimus pull‐down, seated row, chest press, elbow press (triceps), elbow curl (biceps), hip flexion, hip extension, abdominal crunches, leg press and squat

Compliance

• Intervention uptake: 13/13,12/12,17/17,13/13 for flexibility, aerobic, resistance and combined groups, respectively

• Adherence: Adherence to the exercise prescription was calculated as a proportion of completed sessions over the total possible number of sessions in the assigned exercise programme. Mean percentage scores were as follows: flexibility = 85, aerobic = 81, resistance = 91 and aerobic plus resistance = 86. Although participants were encouraged to complete their exercise log, only 50% successfully did so

• Attrition: 42/55. Forty‐two women completed the study; however, five of these women returned the survey data form but refused final fitness testing because of time constraints related to work and family obligations. Thirteen women (24%) did not complete their assigned 12‐week programme. All dropped out by week 6, except one woman, who developed appendicitis after the 12‐week exercise programme but before she could complete the postintervention testing. No poststudy assessments were obtained from these women. The most frequently cited reason given for discontinuing the exercise programme was perceived difficulty fitting the exercise into their lives because of work and/or family responsibilities (seven women). One woman had her breast reconstruction surgery rescheduled so that completion became impossible, one did not give a reason, and one could not complete the initial fitness testing because of an elevated HR. Two women cited the need for additional supervised exercise sessions because they could not maintain motivation on their own

• Adverse effects: Adverse effects were reported in two women during the study. In both cases, the women developed tendonitis: one in the shoulder and the other in the foot. Both had a history of tendonitis, and both received standard treatment (i.e. rest, anti‐inflammatory medication, and gentle movement). Both women resumed exercise at a lesser intensity, progressed their exercise over time and completed the study without further incident

• Achieves Rock et al guidelines: 12 weeks of resistance exercise at two or three times per week. Aerobic prescription: unclear

Description of usual care

Unclear

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomisation table

Allocation concealment (selection bias)

Low risk

Computer‐generated randomisation table maintained by office staff in the clinical research office

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Physical fitness testing was performed at a hospital‐based fitness centre. The same research assistant, blinded to participant group allocation, performed these measurements at pre‐intervention and postintervention measurement time points

Incomplete outcome data (attrition bias)
All outcomes

High risk

Thirteen women (24%) did not complete their assigned 12‐week programme

Selective reporting (reporting bias)

High risk

Waist, upper and mid and lower arm circumference measures not reported

Other bias

High risk

• A significant number of the dropouts belonged to the resistance exercise group (n = 8/13). These women did not verbalise any discontent with this specific modality of exercise; their reasons for dropping out were as previously described. Of note, these women had significantly stronger muscular endurance measurements than were reported in the non‐dropout group

• Second, significant differences were noted in baseline levels of fatigue (P = 0.003), with the dropout group perceiving a greater level of fatigue. Baseline leisure time activity was also markedly different. Women in the completion group reported a significantly greater weekly volume of low to moderate physical activity. In the dropout group, however, scores ranged from 0 to 12, indicating very little general activity

• Only 50% of activity logs were returned

Methods

• Study design: RCT individual participant level randomisation

• Study location (WHO income taxonomy): Maryland, US (high)

• Funding source: funded by the National Cancer Institute (CA R01‐78801)

• Inclusion criteria: (a) English speaking, (b) between 21 and 75 years of age, (c) sedentary lifestyle (i.e. exercise fewer than three times per week for greater than 30 minutes/session, at a moderate intensity, in last six months), (d) average or below average fitness as determined by a graded exercise test (GXT) and (e) recent diagnosis of breast cancer (Stage 0, I, II or IIIa)

• Exclusion criteria: (a) non－cancer‐related contraindications to aerobic walking exercise (e.g. symptomatic coronary artery disease, psychotic spectrum mental illness, orthopaedic problems), (b) pre‐existing metabolic disease (e.g. diabetes, uncontrolled hypertension) and (c) a contraindication to exercise discovered on the exercise stress test

• CONSORT diagram included: no

• Number of participants in each arm: 51 participants in total. Numbers randomly assigned to each arm are unclear

• Trial recruitment rate: 51/57

• Length of follow‐up: length of intervention = 3 months, length of follow‐up from baseline = 3 months

Participants

• Primary cancer diagnosis: breast cancer (Stage 0, I, II or IIIa)

• Current cancer treatment: Most (52.9%) women had Stage I breast cancer and underwent lumpectomy surgery (74.1%). Many (44.1%) women received both radiation and chemotherapy, 26.5% received radiation only, 8.8% received chemotherapy only and 20.6% received no adjuvant therapy

• Metastatic disease: none

• Age, years: overall mean (SD) = 50.8 (11.8)

• Sex: female

• BMI: overall mean (SD): 28.8 (6.1)

• Ethnicity: A large percentage of women were black (44.1%), and total ethnic minority group membership was high (45.1%)

• Comorbidities reported: 23.5% of women had CESD depression scores above the clinical cut‐off

Interventions

• Group or supervised intervention: unclear

• Setting: supervised hospital‐based and subsequently home‐based intervention

• Exercise prescription components: aerobic and resistance

• Theoretical basis: transtheoretical model

• CALO‐RE taxonomy components: #1, #5, #8, #9, #10, #12, #15, #16, #19, #20, #21, #22, #23, #24, #25, #26, #29, #35

• Frequency of contact with researchers or exercise professionals: supervised exercise sessions three times a week for 4 weeks during hospital phase. Thereafter, intervention participants received weekly contact by telephone or electronic mail according to participant preference

• Instructions to controls: Women in the information control group received a 45‐minute session covering their fitness, strength and flexibility assessment results and an informational brochure. The session specifically excluded discussion of strategies addressing exercise barriers, and participants who asked about exercise were told to “do the best you can”. To facilitate participant retention, the control group was contacted once per month, and one week before follow‐up assessment, they were given a pedometer for data collection purposes (Note: Pedometer data were not part of the article)

Outcomes

• Change in fitness reported: no

• Free living energy expenditure: unclear

Process measures

• Method of measuring exercise behaviour: Participants were provided with monthly calendars to record their exercise activity and were contacted weekly by telephone or electronic mail according to their preference. Godin Leisure Time Exercise Questionnaire and the LTEQ self‐report instrument surveys were also used

• Aerobic exercise frequency

• • Hospital‐based phase (first 4 weeks): three times per week

  • Home‐based phase: at least three days per week

• Aerobic exercise duration

• • Hospital‐based phase (first 4 weeks): 15 to 45 minutes

  • Home‐based phase: 30 minutes or longer

• Aerobic exercise intensity

• • Hospital‐based phase: 50% to 85% max HR

  • Home‐based phase: moderate intensity, RPE 11 to 16

• Description aerobic exercise mode: home or treadmill walking

• Resistance exercise frequency

• • Hospital‐based phase: three per week

  • Home‐based phase: Participants were asked to continue resistance training three times a week

• Resistance exercise sets

• • Hospital‐based phase: 1 to 2 sets

  • Home‐based phase: maintaining the same numbers of sets and repetitions

• Resistance exercise repetitions

• • Hospital‐based phase: 12 to 15

  • Home‐based phase: maintaining the same numbers of sets and repetitions

• Resistance exercise intensity

• • Hospital‐based phase: 12 repetitions at the lightest weight, and, as tolerated, repetitions were increased to 15 after the first week. After a participant could perform 15 repetitions of an exercise, another set was added. Upper body exercises were performed with a padded weight belt with interchangeable 1.0 lb bars used to adjust the total weight up to a maximum of 20 lb. Participant body weight was used for lower body exercises

  • Home‐based phase: maintain

• Description of resistance exercise: The resistance programme consisted of upper body (bicep curl, triceps extension, chest fly, military press, upright row and shoulder shrug) and lower body (leg squat and lunge) exercises

Compliance

• Intervention uptake: unclear

• Adherence: Women assigned to the structured intervention completed an average of 83% of their scheduled hospital‐based exercise sessions (mean = 9.9, SD = 3.3 sessions), and 76.9% completed all 12 sessions. LTEQ scores increased from baseline by 157% (from M = 9.7, SD = 8.1 to M = 25.0, SD = 13.1) in the intervention group and by 32.7% among the control group (from M = 10.7, SD = 12.8 to M = 14.2, SD = 11.8). Home‐based adherence is not clear

• Attrition: unclear. No details on numbers randomly assigned to each arm. An overall study completion figure of 80.4% is cited (i.e. participants completing follow‐up assessments)

• Adverse effects: unclear

• Achieves Rock et al guidelines: unclear

Description of usual care

unclear

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Participants were stratified by cancer stage and were randomly assigned to groups

Allocation concealment (selection bias)

Low risk

Participant assignment to groups at enrolment was concealed from the project director

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Physicians monitoring graded exercise tests were blinded to participant group assignment. Similarly, a physical therapist or an exercise physiologist, blinded to participant assignment, performed strength assessments

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Intent‐to‐treat analysis done and multiple imputation used

Selective reporting (reporting bias)

Low risk

None

Other bias

High risk

Numbers randomly assigned to intervention and control groups are unclear, as are numbers completing in each arm

Methods

• Study design: RCT individual participant level randomisation

• Study location (WHO income taxonomy): Rhode Island, US (High)

• Funding source: This study was supported by Grant RO3 MH55570 from the National Institute of Mental Health to Dr Pinto

• Inclusion criteria: Sedentary women (exercised fewer than three times per week for 20 minutes per session) who had been diagnosed with breast cancer (Stage 0, I or II) over the past 3 years. Post‐surgery patients who had completed chemotherapy or radiation treatment were invited to participate in a 12‐week exercise programme or a wait‐list control group (CG)

• Exclusion criteria: Medical or current psychiatric illness that would make compliance with the study protocol difficult or dangerous (e.g. coronary artery disease, hypertension, diabetes), orthopaedic problems or neuropathies that would limit exercise training. Medications that would alter training responses (e.g. beta blockers) or affect distress outcomes (e.g. antidepressants) were also reasons for exclusion

• CONSORT diagram included: no

• Number of participants in each arm: 12 in the intervention group versus 12 in the wait list control group

• Trial recruitment rate: 24/53*

• Length of follow‐up: length of intervention = 12 weeks, length of follow‐up from baseline = 12 weeks

Participants

• Primary cancer diagnosis: Stage 0 to II breast cancer, postsurgery participants who had completed chemotherapy or radiation treatment

• Current cancer treatment: none

• Metastatic disease: none

• Age, years: overall mean (SD): 52.5 (6.8)

• Gender: women

• BMI: overall mean (SD): 26.8 (4.1)

• Ethnicity: all white

• Comorbidities reported: unclear

Interventions

• Group or supervised intervention: unclear

• Setting: supervised and home‐based exercise

• Exercise prescription components: aerobic and resistance exercise (resistance exercise was introduced only for last 4 weeks of the 12‐week programme)

• Theoretical basis: none

• CALO‐RE taxonomy components: #5, #9, #15, #16, #21, #26

• Frequency of contact with researchers or exercise professionals: An exercise physiologist monitored participants’ blood pressure and heart rate once a week before, during and after exercise. Individual exercise prescriptions were updated before each session. Unclear whether physiologist was present at each exercise session

• Instructions to controls: asked not to change their current level of physical activity

Outcomes

• Change in fitness reported: aerobic exercise tolerance test performed but no control group comparison data reported

• Free living energy expenditure: unclear

Process measures

• Method of measuring exercise behaviour: attendance at supervised exercise sessions. Individual exercise prescriptions were updated before each session

• Aerobic exercise frequency: three times per week

• Aerobic exercise duration: Over the 12 weeks, the exercise session developed into 10 minutes of warm‐up (cardiovascular and flexibility), 10 minutes of cool‐down (cardiovascular and flexibility) and 30 minutes of cardiovascular activity within an individual's target heart rate zone

• Aerobic exercise intensity: 60% to 70% of peak heart rate by the end of the 12‐week intervention

• Description aerobic exercise mode: Cardiovascular activities included treadmill walking, arm and leg ergometers, arm cycling, stationary cycling and rowing. To tailor the programme for women who had undergone breast surgery and to improve upper body endurance, investigators encouraged arm cycling and rowing during the sessions. Participants used at least three modes of physical activity per session that would ensure at least one cardiovascular arm activity

• Resistance exercise frequency: N/A less than 6 weeks

• Resistance exercise sets: N/A less than 6 weeks

• Resistance exercise repetitions: N/A less than 6 weeks.

• Resistance exercise intensity: N/A less than 6 weeks

• Description of resistance exercise: N/A less than 6 weeks

Compliance

• Intervention uptake: unclear－"Three women discontinued participation within the first four weeks of the 12‐week programme"

• Adherence: Of the 12 participants in the exercise group, three women discontinued participation within the first four weeks of the 12‐week programme (reasons included child care responsibilities and inconvenience of travelling to the hospital). These individuals provided questionnaire data at postassessments but did not complete post‐treatment exercise tolerance tests. The remaining participants attended a mean of 88% of the 36‐session exercise programme and completed the exercise tolerance test and questionnaire assessments at post‐treatment. Adherence rate to the home‐based component of the exercise prescription was unclear

• Attrition: Nine participants were lost to follow‐up (three in the exercise group, six in the control group)

• Adverse effects: not reported; however, it is unclear why the six controls dropped out

• Achieves Rock et al guidelines: unclear

Description of usual care

Unclear

Notes

*We estimated trial recruitment rate on the basis of numbers randomly assigned of those approached and eligible

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Incomplete outcome data (attrition bias)
All outcomes

High risk

Exercise tolerance test performed but no control group comparison data reported. 38% lost to follow‐up

Selective reporting (reporting bias)

High risk

None of the physiological assessments were performed for the control group at 12 weeks

Other bias

High risk

A statistically significant difference was noted between groups for body esteem at baseline (weight concerns and physical
condition subscales)

Methods

• Study design: RCT individual participant level randomisation

• Study location (WHO income taxonomy): Rhode Island, US (high)

• Funding source: supported by National Cancer Institute Grant No. CA 75452 (BMP)

• Inclusion criteria: Eligibility criteria included age 18 years; currently sedentary (exercised one time per week for 20 minutes at vigorous intensity or two times per week for 30 minutes at moderate intensity for the past six months)*; diagnosed with Stage 0 to II breast cancer over the past 5 years; completed surgery, chemotherapy and/or radiation; ambulatory (able to walk a mile without assistive devices); and willing to be randomly assigned

• Exclusion criteria: Participants were excluded if they had a prior history of cancer (exception: non‐melanoma skin cancer), or if they had a medical or current psychiatric illness that could make compliance with the study protocol difficult or dangerous (e.g. cardiovascular disease, diabetes, orthopaedic problems that limit exercise training)

• CONSORT diagram included: yes

• Number of participants in each arm: 43 in the intervention group and 43 in the control group

• Trial recruitment rate: 86/123

• Length of follow‐up: 12 weeks of "treatment" with nine months of follow‐up from baseline

Participants

• Primary cancer diagnosis: breast cancer Stage 0 to II

• Current cancer treatment: 49% of intervention group and 74% of control group receiving hormone treatment

• Metastatic disease: none

• Age, years: mean (SD): intervention: 53.4 (9.1), control: 52.9 (10.4)

• Sex: women

• BMI: mean (SD): intervention: 27.5 (5.0), control: 28.6 (5.5)

• Ethnicity: 95% white

• Comorbidities reported: unclear

Interventions

• Group or supervised intervention: individual

• Setting: home based

• Exercise prescription components: aerobic

• Theoretical basis: transtheoretical model

• CALO‐RE taxonomy components: #5, #8, #12, #16, #17, #19

• Frequency of contact with researchers or exercise professionals: After randomisation, each intervention participant received in‐person instructions on how to exercise at a moderate intensity level, how to monitor heart rate, and how to warm up before exercise and cool down after exercise. Also, intervention participants received weekly phone calls for 12 weeks, then calls every month for three months

• Instructions to controls: Control participants were asked to refrain from changing their current level of activity during the 12 weeks. They received a weekly phone call from research staff for 12 weeks to match the frequency of contact with the intervention group. These women received the same cancer survivorship tip sheets as the PA group

Outcomes

• Change in fitness reported: aerobic exercise tolerance assessed by a timed one‐mile walk test

• Free living energy expenditure: total weekly energy expenditure (kcal/kg/wk) calculated from the seven‐day physical activity recall questionnaire

Process measures

• Method of measuring exercise behaviour: seven‐day physical activity recall questionnaire and accelerometer data providing kcal/h

• Aerobic exercise frequency: two to five days per week

• Aerobic exercise duration: 10 to 30 minutes

• Aerobic exercise intensity: The programme promoted moderate intensity activities at 55% to 65% of maximum heart rate

• Description of aerobic exercise mode: brisk walking, biking, swimming or use of home exercise equipment

• Resistance exercise frequency: N/A

• Resistance exercise sets: N/A

• Resistance exercise repetitions: N/A

• Resistance exercise intensity: N/A

• Description of resistance exercise: N/A

Compliance

• Intervention uptake: 43/43

• Adherence:

• • Pinto 2005: 15 of 43 in the intervention group and 0 of 41 in the control group accumulated at least 30 minutes of moderate intensity physical activity (eg, walking briskly, heavy house work) on most, ideally all, days of the week as reported by seven‐day recall questionnaires. No changes were reported in accelerometer data in the intervention group (change score = ‐0.33 kcal/h).

  • Pinto 2009: from heart rate data: At week 1, participants reported an average of 43.12 minutes of exercise (SD 44.32) and at week 12, a mean of 128.53 minutes/wk of exercise (SD 76.82), at between 55% and 65% of predicted max heart rate. However, less than 75% of the intervention group were meeting the prescribed goal after week 4.

• Attrition: Four dropped out in the intervention arm and did not provide data at the post‐treatment assessment. Reasons for dropout included no time (n = 1); could not be contacted to determine reasons (n = 2); and participation terminated (n = 1) (the study team terminated one woman’s participation because of symptoms of chest pain during exercise and her refusal to have these symptoms evaluated by her physician)

• Adverse effects: not clear whether chest pain was related to exercise in dropout whose participation was terminated

• Achieves Rock et al guidelines: no

Description of usual care

Unclear

Notes

*Data from baseline questionnaires indicated that two participants in the intervention group were active at baseline (i.e. a discrepancy was noted between telephone screening and assessment). However, the author has advised that outliers were removed during data analysis of trial outcomes. Author advised that accelerometer data should have been reported as kcal/h)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Intention‐to‐treat approach used and low attrition reported (5%)

Selective reporting (reporting bias)

Low risk

All outcomes reported

Other bias

High risk

Significantly more control group participants were receiving hormone treatment: 49% versus 74% in the intervention and control groups, respectively (P = 0.015). Ojective accelerometer data do not support the self‐reported physical activity behaviour

Methods

• Study design: RCT individual participant level randomisation

• Study location (WHO income taxonomy): Rhode Island, US (high)

• Funding source: This study was funded by the National Cancer Institute (CA 101770 to Dr Pinto)

• Inclusion criteria: (i) Men and women aged ≥ 18 years; (ii) completed primary and adjuvant treatments for colon or rectal cancer (Stages I to III); (iii) ≤ 5 years since treatment completion; (iv) able to read and speak English; (v) provided consent for medical chart review; (vi) able to walk unassisted; (vii) sedentary, which was defined as exercising < 60 minutes/wk at moderate intensity PA or < 20 minutes/wk of vigorous intensity PA over the past six months; and (viii) had access to a telephone

• Exclusion criteria: Patients with a prior history of cancer were excluded. Another exclusion criterion was a medical or current psychiatric illness (e.g. orthopaedic problems) that could make compliance with the study protocol difficult or unsafe. Patients with cardiovascular disease and/or diabetes were included if their treating physicians approved of their study participation

• CONSORT diagram included: yes

• Number of participants in each arm: 20 in the intervention group and 26 in the control group

• Trial recruitment rate: 46/66

• Length of follow‐up: 12 weeks of counselling with 12 months of follow‐up from baseline

Participants

• Primary cancer diagnosis: 57% colon cancer, 43% rectal cancer

• Current cancer treatment: none

• Metastatic disease: none

• Age, years: mean (SD): control: 55.6 (8.24), intervention: 59.5 (11.2)

• Gender: 56% female

• BMI: mean (SD): control: 29.4 (6.1), intervention: 27.9 (6.0)

• Ethnicity: 1 of 46 nonwhite

• Comorbidities reported: unclear

Interventions

• Group or supervised intervention: individual

• Setting: home based and facilitated with phone calls

• Exercise prescription components: aerobic

• Theoretical basis: transtheoretical model, social cognitive theory

• CALO‐RE taxonomy components: #5, #8, #9, #12, #16, #17, #19, #21, #23, #24, #26

• Frequency of contact with researchers or exercise professionals: After an initial one‐to‐one consultation, each participant received a weekly call over 12 weeks from research staff to monitor physical activity participation, identify relevant health problems, solve any barriers to physical activity and reinforce participants for their efforts

• Instructions to controls: were asked not to change their usual level of activity

Outcomes

• Change in fitness reported: timed one‐mile walk with estimation of VO₂ peak

• Free living energy expenditure: calories per week estimated from CHAMPS questionnaire

Process measures

• Method of measuring exercise behaviour: questionnaires－seven‐day physical activity recall; community healthy activities model programme for seniors (CHAMPS); stage of motivational readiness for physical activity. Accelerometer data also collected

• Aerobic exercise frequency: two to five times per week

• Aerobic exercise duration: 10 to 30 minutes

• Aerobic exercise intensity: The programme promoted moderate intensity aerobic activities at 64% to 76% of estimated maximum heart rate

• Description aerobic exercise mode: Brisk walking, biking, or use of home exercise equipment was recommended

• Resistance exercise frequency: N/A

• Resistance exercise sets: N/A

• Resistance exercise repetitions: N/A

• Resistance exercise intensity: N/A

• Description of resistance exercise: N/A

Compliance

• Intervention uptake: 20/20

• Adherence:

• • Goal of 150 minutes/wk of PA was met or exceeded by 64.7% of the intervention group versus 40.9% of the control group at three months, by 38.9% of the intervention group versus 27.3% of the control group at six months and by 31.6% of the intervention group versus 21.7% of the control group at 12 months

  • Physical activity of moderate intensity (recorded using the three‐day PAR questionnaire) was compared with the corresponding accelerometer data over three days. Spearman rank correlations were weak at baseline (r = 0.12) because of a high proportion of sedentary participants. Correlation at the three‐month follow‐up showed the only significant between‐group change reported in exercise minutes: r = 0.32

• Attrition: 1/20 at three, six and 12 months in the intervention arm; 2/26 at three, 3/26 at six and 12 months in the control group

• Adverse effects: one cancer recurrence in the control group at three months

• Achieves Rock et al guidelines: Self‐report indicates that 64.7% of the intervention group and 40.9% of the control group were achieving the guidelines. However, accelerometer data are not provided to support this. Further, only a weak correlation was reported between self‐report and accelerometer data at three months

Description of usual care

Unclear

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Insufficient information to permit a "low" or "high" risk judgement

Incomplete outcome data (attrition bias)
All outcomes

Low risk

< 10% attrition reported

Selective reporting (reporting bias)

High risk

Accelerometer data not reported

Other bias

High risk

Accelerometer correlation with self‐report questionnaires is weak at follow‐up points when significant differences between groups in physical activity are reported (i.e. r = 0.32 at 3 months). Substantial contamination in the control group