Clinical Trial

Home-Based Lower-Extremity Heat Therapy for Walking Function in Peripheral Artery Disease

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Summary
Lower-extremity peripheral artery disease is associated with impaired walking ability, reduced lower-extremity function, and decreased quality of life. This randomized, sham-controlled clinical trial will evaluate the effects of 12 weeks of home-based lower-extremity heat therapy on walking function and mobility in adults with peripheral artery disease. A total of 40 participants will be randomized to active lower-extremity heat therapy or sham therapy. Participants assigned to active therapy will complete daily 90-minute home treatment sessions using heated lower-extremity garments. Participants assigned to sham therapy will complete the same treatment schedule using a lower-temperature sham condition. The primary outcome is the change in six-minute walk distance from baseline to 12 weeks. Secondary outcomes include changes in leg strength and fatigability, Short Physical Performance Battery score, blood pressure, and patient-reported quality of life.
Trial Details
NCT Number NCT07653243
Lead Sponsor Aquilo Sports, LLC
Collaborators: Indiana University, Purdue University
Conditions PAD, PAD - Peripheral Arterial Disease
Enrollment 40 participants
Start Date 2027-01-01
Primary Completion 2029-03-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-17