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Home-Based Lower-Extremity Heat Therapy for Walking Function in Peripheral Artery Disease
Sponsor: Aquilo Sports, LLC
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.
Official title: A Randomized, Sham-Controlled Trial of Home-Based Lower-Extremity Heat Therapy in Adults With Peripheral Artery Disease
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2027-01-01
Completion Date
2029-06-30
Last Updated
2026-06-17
Healthy Volunteers
No
Conditions
Interventions
Lower-Extremity Heat Therapy
Participants assigned to the active intervention will complete home-based lower-extremity heat therapy sessions for 90 minutes per day for 12 weeks. The active condition will deliver heated therapy to the lower extremities according to the study protocol.
Sham Lower-Extremity Heat Therapy
Participants assigned to the sham comparator will complete home-based sham therapy sessions for 90 minutes per day for 12 weeks. The sham condition will use the same treatment schedule and similar lower-extremity garments as the active condition, but will use a lower-temperature condition intended to support participant blinding while minimizing the expected physiological effects of active heat therapy.
Locations (1)
Methodist Hospital
Indianapolis, Indiana, United States