Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. 2013

Hugo J P Fokkenrood, and Bianca L W Bendermacher, and Gert Jan Lauret, and Edith M Willigendael, and Martin H Prins, and Joep A W Teijink
Department of Vascular Surgery, Catharina Hospital, Michelangelolaan 2, Eindhoven, Netherlands, 5623 EJ.

BACKGROUND Although supervised exercise therapy is considered to be of significant benefit for people with leg pain (peripheral arterial disease (PAD)), implementing supervised exercise programs (SETs) in daily practice has limitations. This is an update of a review first published in 2006. OBJECTIVE The main objective of this review was to provide an accurate overview of studies evaluating the effects of supervised versus non-supervised exercise therapy on maximal walking time or distance on a treadmill for people with intermittent claudication. METHODS For this update, the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched September 2012) and CENTRAL (2012, Issue 9). In addition, we handsearched the reference lists of relevant articles for additional trials. No restriction was applied to language of publication. METHODS Randomized clinical trials comparing supervised exercise programs with non-supervised exercise programs (defined as walking advice or a structural home-based exercise program) for people with intermittent claudication. Studies with control groups, which did not receive exercise or walking advice or received usual care (maintained normal physical activity), were excluded. METHODS Two review authors (HJPF and BLWB) independently selected trials and extracted data. Three review authors (HJPF, BLWB, and GJL) assessed trial quality, and this was confirmed by two other review authors (MHP and JAWT). For all continuous outcomes, we extracted the number of participants, the mean differences, and the standard deviation. The 36-Item Short Form Health Survey (SF-36) outcomes were extracted to assess quality of life. Effect sizes were calculated as the difference in treatment normalized with the standard deviation (standardized mean difference) using a fixed-effect model. RESULTS A total of 14 studies involving a total of 1002 male and female participants with PAD were included in this review. Follow-up ranged from six weeks to 12 months. In general, supervised exercise regimens consisted of three exercise sessions per week. All trials used a treadmill walking test as one of the outcome measures. The overall quality of the included trials was moderate to good, although some trials were small with respect to the number of participants, ranging from 20 to 304.Supervised exercise therapy (SET) showed statistically significant improvement in maximal treadmill walking distance compared with non-supervised exercise therapy regimens, with an overall effect size of 0.69 (95% confidence interval (CI) 0.51 to 0.86) and 0.48 (95% CI 0.32 to 0.64) at three and six months, respectively. This translates to an increase in walking distance of approximately 180 meters that favored the supervised group. SET was still beneficial for maximal and pain-free walking distances at 12 months, but it did not have a significant effect on quality of life parameters. CONCLUSIONS SET has statistically significant benefit on treadmill walking distance (maximal and pain-free) compared with non-supervised regimens. However, the clinical relevance of this has not been demonstrated definitively; additional studies are required that focus on quality of life or other disease-specific functional outcomes, such as walking behavior, patient satisfaction, costs, and long-term follow-up. Professionals in the vascular field should make SET available for all patients with intermittent claudication.

UI MeSH Term Description Entries
D007383 Intermittent Claudication A symptom complex characterized by pain and weakness in SKELETAL MUSCLE group associated with exercise, such as leg pain and weakness brought on by walking. Such muscle limpness disappears after a brief rest and is often relates to arterial STENOSIS; muscle ISCHEMIA; and accumulation of LACTATE. Claudication, Intermittent
D008297 Male Males
D005081 Exercise Therapy A regimen or plan of physical activities designed and prescribed for specific therapeutic goals. Its purpose is to restore normal musculoskeletal function or to reduce pain caused by diseases or injuries. Rehabilitation Exercise,Remedial Exercise,Therapy, Exercise,Exercise Therapies,Exercise, Rehabilitation,Exercise, Remedial,Exercises, Rehabilitation,Exercises, Remedial,Rehabilitation Exercises,Remedial Exercises,Therapies, Exercise
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D016032 Randomized Controlled Trials as Topic Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table. Clinical Trials, Randomized,Controlled Clinical Trials, Randomized,Trials, Randomized Clinical
D016138 Walking An activity in which the body advances at a slow to moderate pace by moving the feet in a coordinated fashion. This includes recreational walking, walking for fitness, and competitive race-walking. Ambulation
D023801 Directly Observed Therapy A treatment method in which patients are under direct observation when they take their medication or receive their treatment. This method is designed to reduce the risk of treatment interruption and to ensure patient compliance. Therapy, Directly Observed

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