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| Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial [with consumer summary] |
| Gardner AW, Parker DE, Montgomery PS, Scott KJ, Blevins SM |
| Circulation 2011 Feb 8;123(5):491-498 |
| clinical trial |
| 5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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BACKGROUND: This prospective, randomized, controlled clinical trial compared changes in exercise performance and daily ambulatory activity in peripheral artery disease patients with intermittent claudication after a home-based exercise program, a supervised exercise program, and usual-care control. METHODS AND RESULTS: Of the 119 patients randomized, 29 completed home-based exercise, 33 completed supervised exercise, and 30 completed usual-care control. Both exercise programs consisted of intermittent walking to nearly maximal claudication pain for 12 weeks. Patients wore a step activity monitor during each exercise session. Primary outcome measures included claudication onset time and peak walking time obtained from a treadmill exercise test; secondary outcome measures included daily ambulatory cadences measured during a 7-day monitoring period. Adherence to home-based and supervised exercise was similar (p = 0.712) and exceeded 80%. Both exercise programs increased claudication onset time (p < 0.001) and peak walking time (p < 0.01), whereas only home-based exercise increased daily average cadence (p < 0.01). No changes were seen in the control group (p > 0.05). The changes in claudication onset time and peak walking time were similar between the 2 exercise groups (p > 0.05), whereas the change in daily average cadence was greater with home-based exercise (p < 0.05). CONCLUSIONS: A home-based exercise program, quantified with a step activity monitor, has high adherence and is efficacious in improving claudication measures similar to a standard supervised exercise program. Furthermore, home-based exercise appears more efficacious in increasing daily ambulatory activity in the community setting than supervised exercise. CLINICAL TRIAL REGISTRATION: URL http://www.ClinicalTrials.gov. Unique identifier NCT00618670.
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