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