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

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 dailyactivity and contribute to progressive mobility loss. This randomized, sham‐controlledclinical trial will evaluate the effects of 12 weeks of home‐based lower‐extremity heattherapy on walking function, lower‐extremity performance, blood pressure, and quality oflife in adults with peripheral artery disease.A total of 40 participants with peripheral artery disease will be enrolled and randomizedto active lower‐extremity heat therapy or sham therapy. Eligible participants willinclude men and women older than 45 years with a resting ankle‐brachial index of lessthan 0.90 and greater than 0.40 in at least one leg. Participants will be excluded forconditions that may interfere with safe participation or outcome assessment, includingcritical limb ischemia, ischemic rest pain, ischemia‐related non‐healing wounds or tissueloss, prior amputation, major exercise‐limiting comorbidity, recent lower‐extremityrevascularization or orthopedic surgery, use of a walking aid other than a cane, activetreatment for cancer, severe chronic kidney disease, class 2 or 3 obesity, or inabilityto use the study treatment system as intended.Participants will complete baseline study visits that include informed consent, restingankle‐brachial index measurement, familiarization with study procedures, and baselineassessment of walking function and lower‐extremity performance. Baseline outcome measureswill include the six‐minute walk test, assessment of calf strength and fatigability usingisokinetic dynamometry, the Short Physical Performance Battery, and blood pressuremeasurement.After completion of baseline assessments, participants will be randomized to one of twostudy groups using a blocked randomization scheme stratified by sex. Participantsassigned to the active therapy group will complete daily 90‐minute home‐basedlower‐extremity heat therapy sessions for 12 weeks. Participants assigned to the shamtherapy group will complete the same treatment schedule using a lower‐temperature shamcondition designed to preserve participant blinding while minimizing the expectedphysiological effects of active heat therapy.Outcome assessments will be repeated at week 6 and week 12. To evaluate chronic ratherthan acute responses to treatment, participants will be instructed to interrupt therapy48 hours before follow‐up outcome visits. The primary outcome is the change in six‐minutewalk distance from baseline to 12 weeks. Secondary outcomes include changes in legstrength and fatigability, Short Physical Performance Battery score, blood pressure, andpatient‐reported quality of life.