RecruitingNot ApplicableNCT05465070

Leg Heat Therapy in Peripheral Artery Disease

Leg Heat Therapy to Improve Functional Performance in Peripheral Artery Disease

Sponsor

Indiana University

Enrollment

106 participants

Start Date

Nov 7, 2022

Study Type

INTERVENTIONAL

Conditions

Peripheral Artery Disease

Summary

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).

Eligibility

Min Age: 50 Years

Inclusion Criteria2

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.

Exclusion Criteria12

Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss)
Prior foot or leg amputation
Exercise tolerance limited by factors other than leg pain (e.g. angina, arthritis, severe lung disease, etc).
Recent (<3 months) lower-extremity revascularization or orthopedic surgery
Use of walking aid other than a cane
Active 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 water-circulating trousers
A Mini-Mental Status Examination score <23
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.

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Interventions

DEVICELeg heat therapy

A sous vide heating immersion circulator heats up the water inside the water tank to 42ºC. A water pump circulates temperature-regulated water through the trousers.

DEVICESham Control

A sous vide heating immersion circulator heats up the water inside the water tank to 33ºC. A water pump circulates temperature-regulated water through the trousers.