Leg Heat Therapy in Peripheral Artery Disease

A vizsgálat adatai

Ki végzi

Indiana University

Azonosító

NCT05465070

A regiszteradat frissítve

2026. augusztus 17.

Eredeti leírás

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).A teljes eredeti leírásKevesebb

Leg Heat Therapy to Improve Functional Performance in Peripheral Artery Disease

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).

Bevonási feltételek: Men and women older than 50 years; Resting ankle-brachial index (ABI) of 0.9 or less in at least one leg. Individuals with a resting ABI between 0.91 and 1.00 at baseline will be eligible if their ABI drops by 20% or greater following a heel-rise test.

Kizáró feltételek: Prior foot or leg amputation; Recent (<3 months) lower-extremity revascularization or orthopedic surgery; Exercise tolerance limited by factors other than leg pain (e.g. angina, arthritis, severe lung disease, etc); Active cancer; Impaired thermal sensation in the leg; As this study involves MR imaging, patients that have contraindications to MRI will be included in the study but will not be allowed to participate in the MRI experiment. Information about biomedical devices that may pose a risk to patients undergoing MRI is available on the Internet at www.MRIsafety.com. These exclusions include: cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, cochlear, otologic, or ear implant and history of claustrophobia or who are unable to lie flat or who do not fit inside the bore of the scanner; Chronic kidney disease (eGFR <30 by MDRD or Mayo or Cockcroft-Gault formula); Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss); Use of walking aid other than a cane; Class 2 or 3 obesity (BMI ≥ 35 kg/m2); Unable to fit into water-circulating trousers; A Mini-Mental Status Examination score <23.

ClinicalTrials.gov NCT05465070