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

Starting soon · Not applicable · Has a placebo group

Conditions studied: PAD, PAD - Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT07653243

Run by

Aquilo Sports, LLC

People needed

40

Starts

2027-01-01

Expected to finish

2029-06-30

Last updated by the study team

2026-06-17

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women older than 50 years of age
• Resting ankle-brachial index (ABI) of <0.9 but >0.4 in at least one leg

You may not qualify if…

• Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss
• Prior amputation
• Exercise-limiting comorbidity
• Recent (<3 months) lower-extremity revascularization or orthopedic surgery
• Use of walking aid other than a cane
• Active treatment for cancer
• Chronic kidney disease (eGFR <30 by MDRD or Mayo or Cockcroft-Gault formula)
• Class 2 or 3 obesity (BMI ≥ 35 kg/m2)
• Unable to fit into water-circulating trousers

Where it is running

• Methodist Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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