Condition: Peripheral Artery Disease · Sponsor: Indiana University
The goal of this randomized, double-blind, sham-controlled clinical trial is to evaluate the benefits of home-based, leg heat therapy (HT) on lower-extremity functioning and quality of life in patients who suffer from lower-extremity peripheral artery disease (PAD). We will randomize 106 patients to one of two groups that either receive leg HT or a sham intervention. The primary study outcome is the change in 6-minute walk distance between baseline and the 12-week follow up. Secondary outcomes include changes in the short physical performance battery score, handgrip strength, quality of life (measured by the Walking Impairment Questionnaire and Short-Form (SF)-36 Questionnaire), calf muscle strength (measured using a calf ergometer), size (measured by magnetic resonance imaging) and bioenergetics (assessed using phosphorus-31 magnetic resonance spectroscopy), and physical activity (measured by accelerometer).
This description comes directly from the study's public registry record.
Kimmy Marshall, RN · 317-274-7440 · marshki@iu.edu
Bruno Roseguini, Ph.D. · (765) 496-2612 · brosegui@purdue.edu
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| Indiana University Health Methodist Hospital | Indianapolis, Indiana, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05465070