Leg Heat Therapy in Peripheral Artery Disease

Description

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).

Conditions

Peripheral Artery Disease

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Study Overview

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Study Details

Study overview

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).

Leg Heat Therapy to Improve Functional Performance in Peripheral Artery Disease

Leg Heat Therapy in Peripheral Artery Disease

Condition
Peripheral Artery Disease
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Indiana University Health Methodist Hospital, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Men and women older than 60 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.
  • * 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

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indiana University,

Study Record Dates

2026-12-31