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Supervised exercise therapy versus home-based exercise therapy versus walking advice for intermittent claudication

  • Review
  • Intervention

Authors

  • David Hageman,

    1. Catharina Hospital, Department of Vascular Surgery, Eindhoven, Netherlands
    2. CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine and Life Sciences, Maastricht University, Department of Epidemiology, Maastricht, Netherlands
  • Hugo JP Fokkenrood,

    1. Rijnstate, Department of Vascular Surgery, Arnhem, Netherlands
  • Lindy NM Gommans,

    1. Catharina Hospital, Department of Vascular Surgery, Eindhoven, Netherlands
  • Marijn ML van den Houten,

    1. Catharina Hospital, Department of Vascular Surgery, Eindhoven, Netherlands
    2. CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine and Life Sciences, Maastricht University, Department of Epidemiology, Maastricht, Netherlands
  • Joep AW Teijink

    Corresponding author
    1. Catharina Hospital, Department of Vascular Surgery, Eindhoven, Netherlands
    2. CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine and Life Sciences, Maastricht University, Department of Epidemiology, Maastricht, Netherlands

Abstract

Background

Although supervised exercise therapy (SET) provides significant symptomatic benefit for patients with intermittent claudication (IC), it remains an underutilized tool. Widespread implementation of SET is restricted by lack of facilities and funding. Structured home-based exercise therapy (HBET) with an observation component (e.g., exercise logbooks, pedometers) and just walking advice (WA) are alternatives to SET. This is the second update of a review first published in 2006.

Objectives

The primary objective was to provide an accurate overview of studies evaluating effects of SET programs, HBET programs, and WA on maximal treadmill walking distance or time (MWD/T) for patients with IC. Secondary objectives were to evaluate effects of SET, HBET, and WA on pain-free treadmill walking distance or time (PFWD/T), quality of life, and self-reported functional impairment.

Search methods

The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register (December 16, 2016) and the Cochrane Central Register of Controlled Trials (2016, Issue 11). We searched the reference lists of relevant studies identified through searches for other potential trials. We applied no restriction on language of publication.

Selection criteria

We included parallel-group randomized controlled trials comparing SET programs with HBET programs and WA in participants with IC. We excluded studies in which control groups did not receive exercise or walking advice (maintained normal physical activity). We also excluded studies comparing exercise with percutaneous transluminal angioplasty, bypass surgery, or drug therapy.

Data collection and analysis

Three review authors (DH, HF, and LG) independently selected trials, extracted data, and assessed trials for risk of bias. Two other review authors (MvdH and JT) confirmed the suitability and methodological quality of trials. For all continuous outcomes, we extracted the number of participants, mean outcome, and standard deviation for each treatment group through the follow-up period, if available. We extracted Medical Outcomes Study Short Form 36 outcomes to assess quality of life, and Walking Impairment Questionnaire outcomes to assess self-reported functional impairment. As investigators used different scales to present results of walking distance and time, we standardized reported data to effect sizes to enable calculation of an overall standardized mean difference (SMD). We obtained summary estimates for all outcome measures using a random-effects model. We assessed the quality of evidence using the GRADE approach.

Main results

For this update, we included seven additional studies, making a total of 21 included studies, which involved a total of 1400 participants: 635 received SET, 320 received HBET, and 445 received WA. In general, SET and HBET programs consisted of three exercise sessions per week. Follow-up ranged from six weeks to two years. Most trials used a treadmill walking test to investigate effects of exercise therapy on walking capacity. However, two trials assessed only quality of life, functional impairment, and/or walking behavior (i.e., daily steps measured by pedometer). The overall methodological quality of included trials was moderate to good. However, some trials were small with respect to numbers of participants, ranging from 20 to 304.

SET groups showed clear improvement in MWD/T compared with HBET and WA groups, with overall SMDs at three months of 0.37 (95% confidence interval [CI] 0.12 to 0.62; P = 0.004; moderate-quality evidence) and 0.80 (95% CI 0.53 to 1.07; P < 0.00001; high-quality evidence), respectively. This translates to differences in increased MWD of approximately 120 and 210 meters in favor of SET groups. Data show improvements for up to six and 12 months, respectively. The HBET group did not show improvement in MWD/T compared with the WA group (SMD 0.30, 95% CI -0.45 to 1.05; P = 0.43; moderate-quality evidence).

Compared with HBET, SET was more beneficial for PFWD/T but had no effect on quality of life parameters nor on self-reported functional impairment. Compared with WA, SET was more beneficial for PFWD/T and self-reported functional impairment, as well as for some quality of life parameters (e.g., physical functioning, pain, and physical component summary after 12 months), and HBET had no effect.

Data show no obvious effects on mortality rates. Thirteen of the 1400 participants died, but no deaths were related to exercise therapy. Overall, adherence to SET was approximately 80%, which was similar to that reported with HBET. Only limited adherence data were available for WA groups.

Authors' conclusions

Evidence of moderate and high quality shows that SET provides an important benefit for treadmill-measured walking distance (MWD and PFWD) compared with HBET and WA, respectively. Although its clinical relevance has not been definitively demonstrated, this benefit translates to increased MWD of 120 and 210 meters after three months in SET groups. These increased walking distances are likely to have a positive impact on the lives of patients with IC. Data provide no clear evidence of a difference between HBET and WA. Trials show no clear differences in quality of life parameters nor in self-reported functional impairment between SET and HBET. However, evidence is of low and very low quality, respectively. Investigators detected some improvements in quality of life favoring SET over WA, but analyses were limited by small numbers of studies and participants. Future studies should focus on disease-specific quality of life and other functional outcomes, such as walking behavior and physical activity, as well as on long-term follow-up.

Plain language summary

Supervised exercise therapy vs home-based exercise therapy vs walking advice for patients with leg pain while walking (intermittent claudication)

Background

Intermittent claudication is a cramping leg pain that occurs during walking and is relieved by a short period of rest. It is caused by inadequate blood flow to the muscles of the leg due to atherosclerosis (hardening of the arteries). Exercise therapy provides significant symptomatic benefit for patients with intermittent claudication. Patients are recommended to walk at least three times a week by themselves. However, they can also participate in a formal supervised exercise program that involves walking on a treadmill or complete a structured home-based exercise program with an observation component (e.g., exercise logbooks, pedometers).

Study characteristics and key results

We included 21 trials in which a total of 1400 participants with intermittent claudication (65% male, mean age 66 years) had been assigned to supervised exercise therapy, home-based exercise therapy, or walking advice (search last run December 2016). The overall methodological quality of included trials was moderate to good. However, some trials had enrolled only small numbers of participants. Trials lasted from six weeks to two years.

This review shows that patients participating in a supervised exercise program improve their walking ability to a greater extent than those completing a home-based exercise program or just following walking advice. After three months, the maximal walking distance for participants following the supervised exercise program was 120 or 210 meters farther than the maximal walking distance for those who followed a home-based exercise program or received walking advice, respectively. To put these increases in context, a US football field is roughly 90 meters (or 100 yards) long. Before participating in the exercise program, the maximal walking distance of participants was 290 meters with a pain-free walking distance of 140 meters, so this improvement is likely to have a positive impact on their lives. Results of the home-based exercise program were similar to those reported for walking advice.

Compared with home-based exercise therapy, supervised exercise therapy was more beneficial for pain-free walking distance but had no effect on quality of life measures nor on self-reported functional impairment. Compared with walking advice, supervised exercise therapy was more beneficial for pain-free walking distance and self-reported functional impairment, as well as for some quality of life measures (e.g., physical functioning, pain, and physical component summary after 12 months), and home-based exercise therapy had no effect.

Data show no obvious effects on mortality rates. Thirteen of the 1400 participants died, but no deaths were related to exercise therapy. Overall, adherence to supervised exercise therapy was approximately 80%, which was similar to that reported with home-based exercise therapy. Only limited adherence data were available for walking advice groups.

Quality of the evidence

Evidence of moderate and high quality shows that supervised exercise therapy improves walking distance (maximal and pain-free) to a greater extent than home-based exercise therapy and walking advice, respectively. Trials show no clear differences in quality of life measures nor in self-reported functional impairment between supervised exercise therapy and home-based exercise therapy. However, evidence is of low and very low quality, respectively. Investigators detected some improvements in quality of life favoring supervised exercise therapy over walking advice, but analyses were limited by small numbers of studies and participants. More research is needed on disease-specific quality of life and other functional outcomes, such as walking behavior and physical activity, as well as on long-term follow-up.

Adhering to an exercise program is important because it leads to decreased leg pain and improved quality of life, as well as to likely improvement in general physical condition.

Streszczenie prostym językiem

Nadzorowana terapia ruchowa vs ćwiczenia wykonywane w domu vs porady odnośnie spacerów dla pacjentów z bólem nóg podczas chodzenia (chromanie przestankowe)

Wprowadzenie

Chromanie przestankowe to kurczowy ból nogi, który pojawia się podczas chodzenia i ustępuje po krótkim odpoczynku. Przyczyną jego jest niewystarczający przepływ krwi do mięśni nóg w wyniku miażdżycy (stwardnienia tętnic). Terapia ruchowa przynosi istotne korzyści w odniesieniu do objawów u chorych z chromaniem przestankowym. Pacjentom zaleca się spacery co najmniej trzy razy w tygodniu. Mogą oni uczestniczyć też w programach ćwiczeń nadzorowanych, które obejmują chodzenie na bieżni lub wykonywanie pełnego ustrukturyzowanego programu ćwiczeń w domu z elementem obserwacji (np. dziennik ćwiczeń, krokomierz).

Charakterystyka badań i główne wyniki

Włączyliśmy 21 badań obejmujących łącznie 1400 pacjentów z chromaniem przestankowym (65% mężczyzn, średnia wieku 66 lat), którzy zostali przydzieleni do terapii ruchowej prowadzonej pod nadzorem, terapii ruchowej w domu lub otrzymania porady dotyczącej spacerów (ostatnie wyszukiwanie zostało przeprowadzone w grudniu 2016 roku). Ogólną jakość metodologiczną włączonych badań oceniono jako umiarkowaną do wysokiej. Niektóre badania obejmowały jednak niewielką liczbę uczestników. Badania trwały od sześciu tygodni do dwóch lat.

Niniejszy przegląd wykazuje, że pacjenci uczestniczący w programie ćwiczeń nadzorowanych poprawili swoją zdolność chodzenia w większym stopniu niż ci, którzy ukończyli program ćwiczeń w domu lub stosowali się do porad odnośnie spacerów. Po trzech miesiącach maksymalna długość dystansu osiągana przez uczestników wykonujących ćwiczenia nadzorowane wynosiła o 120 lub 210 metrów więcej niż maksymalny dystans osób uczestniczących w programie ćwiczeń domowych lub otrzymujących porady, odpowiednio. Wydłużenie pokonywanego dystansu można ocenić w kontekście wymiarów boiska do piłki nożnej w USA, które ma długość około 90 m (lub 100 jardów). Przed wzięciem udziału w programie ćwiczeń maksymalny pokonywany dystans uczestników wynosił 290 metrów i 140 metrów bez bólu, więc osiągnięta poprawa może mieć pozytywny wpływ na ich życie. Wyniki interwencji w postaci programu ćwiczeń domowych były podobne do tych, które osiągały osoby otrzymujące porady odnośnie spacerów.

W porównaniu z domowymi ćwiczeniami ruchowymi, terapia nadzorowana była bardziej korzystna pod względem pokonywanego dystansu, ale nie miała wpływu na ocenę jakość życia ani subiektywną ocenę zaburzeń funkcjonalnych. W porównaniu z poradami, ćwiczenia wykonywane pod nadzorem były bardziej korzystne w odniesieniu do dystansu pokonywanego bez bólu oraz subiektywnej oceny zaburzeń funkcjonowania, a także niektórych wskaźników jakości życia (np. funkcjonowanie fizyczne, ból i sumaryczna komponenta fizyczna po 12 miesiącach), natomiast w przypadku terapii ruchowej wykonywanej w domu nie odnotowano efektu.

Dane nie wskazują na jednoznaczny efekt w odniesieniu do śmiertelności. Trzynastu z 1400 uczestników zmarło, ale zgony nie były związane z terapią ruchową Podsumowując, przestrzeganie zaleceń w odniesieniu do ćwiczeń wykonywanych pod nadzorem wynosiło około 80%, a odsetek ten był podobny w grupie osób ćwiczących w domu. Dostępne były jedynie ograniczone dane naukowe na temat przestrzegania porad odnośnie spacerów.

Jakość danych naukowych

Dane naukowe umiarkowanej i wysokiej jakości wskazują, że ćwiczenia nadzorowane poprawiają długość pokonywanego dystansu (odległość maksymalna i bez bólu) w większym stopniu niż terapia ruchowa wykonywana w domu czy porady dotyczące chodzenia. Badania nie wykazały wyraźnych różnic w ocenie jakości życia ani w subiektywnej ocenie zaburzeń funkcjonowania między grupą otrzymującą ćwiczenia nadzorowane, a grupą domowej terapii ruchowej. Jednak dane naukowe są, odpowiednio, niskiej i bardzo niskiej jakości. Badacze zauważyli pewną poprawę w jakości życia na korzyść nadzorowanej terapii ruchowej w porównaniu z poradami dotyczącymi spacerów, jednak analizy były ograniczone przez niewielką liczbę badań i uczestników. Potrzeba większej liczby badań skupiających się na jakości życia związanej z analizowaną chorobą i innych aspektach funkcjonalnych, takich jak: zachowania związane z chodzeniem, aktywność fizyczna, a także na długotrwałej obserwacji.

Przestrzeganie zaleceń podczas programu ćwiczeń jest ważne, gdyż prowadzi do zmniejszenia bólu nóg i poprawy jakości życia, a także prawdopodobnie do poprawy ogólnej kondycji fizycznej.

Uwagi do tłumaczenia

Tłumaczenie: Joanna Zając Redakcja: Małgorzata Kołcz