About 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Lower-Extremity Heat Therapy
- Sham Lower-Extremity Heat Therapy