Unsupervised walking therapy and atherosclerotic risk-factor management for patients with peripheral arterial disease: a pilot trial.

BACKGROUND: Although only a small percentage of patients with peripheral arterial disease (PAD) have claudication, many more suffer from atypical leg symptoms.
PURPOSE: This pilot trial evaluated a risk-factor modification program to improve walking ability in patients with PAD and leg symptoms other than intermittent claudication.
METHODS: Patients 18 years or older with an ankle-brachial index (ABI) of 0.50 to 0.89 completed a baseline assessment of current walking ability, physical activity level, health-related quality of life, glycosylated hemoglobin values, and fasting lipid profiles. Patients were randomized to usual care (control group) versus usual care plus an educational intervention on risk-factor management (intervention group). We compared functional outcomes between and within groups using the Student's t test and control and intervention group outcomes at 12 weeks using analysis of covariance with the baseline value as the covariate.
RESULTS: We randomized 50 patients into two treatment arms. There was no difference in the mean age of patients in each group. At baseline, mean ABI for the control versus the intervention group was 0.72 (SD = 0.10) and 0.75 (SD = 0.10), respectively, and mean stair-climbing values did not differ between groups. At 12 weeks, mean stair-climbing values were 40.2 (SD = 30.2) for the control and 61.2 (SD = 32.8) for the intervention group. The difference in adjusted mean walking distance between groups at 12 weeks was not significant. Analysis of covariance associated assignment to the intervention versus the control arm with a significant increase at 12 weeks in the ABI (p = .008) and stair-climbing ability (p = .02).
CONCLUSIONS: Patients in the intervention group improved objective measures of blood flow and reported stair-climbing ability.

RCT Entities:   Population Interventions Outcomes