RECRUITING

Leg Heat Therapy in Peripheral Artery Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Leg Heat Therapy to Improve Functional Performance in Peripheral Artery Disease

Quick Facts

Study Start:2022-11-07
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05465070

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.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women older than 60 years
  2. * 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.
  1. * Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss)
  2. * Prior foot or leg amputation
  3. * Exercise tolerance limited by factors other than leg pain (e.g. angina, arthritis, severe lung disease, etc).
  4. * Recent (\<3 months) lower-extremity revascularization or orthopedic surgery
  5. * Use of walking aid other than a cane
  6. * Active cancer
  7. * Chronic kidney disease (eGFR \<30 by MDRD or Mayo or Cockcroft-Gault formula)
  8. * Class 2 or 3 obesity (BMI ≥ 35 kg/m2)
  9. * Unable to fit into water-circulating trousers
  10. * A Mini-Mental Status Examination score \<23
  11. * Impaired thermal sensation in the leg

Contacts and Locations

Study Contact

Janet Klein, RN
CONTACT
(317) 962-0287
jswklein@iupui.edu
Bruno Roseguini, Ph.D.
CONTACT
(765) 496-2612
brosegui@purdue.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-07
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-11-07
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • heat therapy
  • peripheral artery disease
  • walking performance
  • muscle strength

Additional Relevant MeSH Terms

  • Peripheral Artery Disease