A Randomized, Sham-Controlled Trial of Home-Based Lower-Extremity Heat Therapy in Adults With Peripheral Artery Disease
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.
Description
Lower-extremity peripheral artery disease is associated with impaired walking ability, reduced lower-extremity function, exercise intolerance, and decreased quality of life. Reduced physical function in individuals with peripheral artery disease can limit daily activity and contribute to progressive mobility loss. This randomized, sham-controlled clinical trial will evaluate the effects of 12 weeks of home-based lower-extremity heat therapy on walking function, lower-extremity performance, blood pressure, and quality of life in adults with peripheral artery disease. A total of 40 participants…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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…
Interventions
- DeviceLower-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.
- DeviceSham 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.
Location
- Methodist HospitalIndianapolis, Indiana