At a glance
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Low InTensity Exercise Intervention in PAD
In Brief
A clinical study evaluating Exercise and Attention control for Peripheral Artery Disease. Completed, enrolled 305 participants across 4 sites.
Detailed Summary
This proposed study will determine whether a home-based exercise intervention that avoids continuous supervision and exercise-related ischemic pain improves walking performance at 52-week follow-up in people with PAD, compared to an attention control group and compared to a high intensity exercise intervention. In our secondary aims, we will determine whether high intensity exercise improves six-minute walk distance as compared to the attention control group. In secondary aims, we will also determine whether low intensity exercise and high intensity home-based exercise, respectively, improve patient reported outcomes, physical activity, and treadmill walking performance compared to attention control. Our intervention directly addresses two aspects of current practice guidelines that are major barriers to exercise for patients with PAD: 1) the recommendation for supervised exercise and 2) the recommendation for high intensity ischemic-pain inducing walking exercise.
Study Details
Timeline
Interventions
Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach.
Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic.