Home-based leg heat therapy for improving walking in patients with peripheral artery disease
Leg Heat Therapy to Improve Functional Performance in Peripheral Artery Disease
This study is testing if a home-based leg heat therapy can help people with peripheral artery disease walk better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05465070 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of home-based leg heat therapy on lower-extremity functioning and quality of life in patients with peripheral artery disease (PAD). A total of 106 participants will be randomly assigned to receive either leg heat therapy or a sham treatment for 90 minutes daily over three months. The primary outcome is the change in 6-minute walk distance, while secondary outcomes include various measures of physical performance, muscle strength, and quality of life. The study aims to provide a feasible therapy option for patients suffering from PAD who may have limited access to traditional treatments.
Who should consider this trial
Good fit: Ideal candidates are men and women over 60 years old with a resting ankle-brachial index of 0.9 or less in at least one leg.
Not a fit: Patients with critical limb ischemia, recent lower-extremity surgeries, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly enhance walking performance and overall quality of life for patients with peripheral artery disease.
How similar studies have performed: While similar approaches have been explored, this specific application of home-based leg heat therapy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Indianapolis, Indiana
- Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Kimmy Marshall, RN
- Email: marshki@iu.edu
- Phone: 317-274-7440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.