Heat Therapy for Peripheral Artery Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Raghu Motaganahalli, MD
Principal Investigator
Indiana University
Are You a Good Fit for This Trial?
This trial is for adults with peripheral artery disease who have trouble walking or reduced leg function. Participants must be able to safely use heat therapy at home and follow the study schedule.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Lower-Extremity Heat Therapy
Trial Overview
The study compares daily home-based heated leg garment therapy to a sham (low-heat) version over 12 weeks, aiming to see if real heat therapy improves walking distance and leg strength in people with peripheral artery disease.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants assigned to this arm will complete home-based lower-extremity heat therapy sessions for 90 minutes per day for 12 weeks. The active therapy condition will use heated lower-extremity garments according to the study protocol.
Participants assigned to this arm will complete sham home-based lower-extremity therapy sessions for 90 minutes per day for 12 weeks. The sham condition will use the same treatment schedule and similar lower-extremity garments, with a lower-temperature condition designed to preserve participant blinding while minimizing the expected physiological effects of active heat therapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aquilo Sports, LLC
Lead Sponsor
Indiana University
Collaborator
Purdue University
Collaborator
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