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Not Yet Recruiting NCT07653243

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

Conditions: PAD, PAD - Peripheral Arterial Disease

Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Aquilo Sports, LLC

Location: Methodist Hospital Indianapolis Indiana

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.

Eligibility Criteria

Inclusion Criteria: * Men and women older than 50 years of age * Resting ankle-brachial index (ABI) of \0.4 in at least one leg Exclusion Criteria: * Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss * Prior amputation * Exercise-limiting comorbidity * Recent (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07653243). StuddyBuddy aggregates publicly available trial information.