Leg Heat Therapy to Improve Functional Performance in Peripheral Artery Disease
Overview
- Phase
- Not Applicable
- Intervention
- Leg heat therapy
- Conditions
- Peripheral Artery Disease
- Sponsor
- Indiana University
- Enrollment
- 106
- Locations
- 2
- Primary Endpoint
- Change in 6-minute walk distance
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief 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).
Detailed Description
The lack of accessible therapies amenable for application in the home setting is a major obstacle for treating patients who suffer from lower-extremity peripheral artery disease (PAD). The investigators will determine whether unsupervised, home-based leg heat therapy (HT) improves walking performance compared to a sham intervention. Leg HT will be applied using water-circulating trousers coupled with a water pump and a water heater. Patients will be randomized into one of two groups: those receiving HT (n=53) or those receiving a sham treatment (n=53).The water heater and pump given to participants in the HT group will be adjusted to circulate water at 42ºC through the trousers. In the sham group, water at 33ºC will be circulated through the trousers. Participants will be asked to apply the therapy daily for 90 min for 3 consecutive months. Outcomes will be assessed at baseline, at the completion of the intervention (end of week 12) and at a follow-up visit, 12 weeks after the end of the intervention (week 24). 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, which combines performance in walking speed, standing balance, and repeated chair rises, changes in handgrip strength, perceived 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).
Investigators
Raghu Motaganahalli
Professor, Surgery
Indiana University
Eligibility 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
Arms & Interventions
Heat therapy
Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 42ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.
Intervention: Leg heat therapy
Sham Control
Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 33ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.
Intervention: Sham Control
Outcomes
Primary Outcomes
Change in 6-minute walk distance
Time Frame: Baseline to 3-month follow-up
The investigators will determine whether daily leg heat therapy for 90 min using water-circulating trousers perfused with water heated to 42ºC improves the 6-minute walk distance at 3-month follow-up compared to a sham treatment.
Secondary Outcomes
- Change in Short-Form (SF)-36 Questionnaire score(Baseline to 3-month follow-up)
- Change in systolic blood pressure(Baseline to 3-month follow-up)
- Change in Short Physical Performance Battery (SPPB) score(Baseline to 3-month follow-up)
- Change in handgrip strength(Baseline to 3-month follow-up)
- Change in Walking Impairment Questionnaire (WIQ) score(Baseline to 3-month follow-up)
- Change in triceps surae volume(Baseline to 3-month follow-up)
- Change in triceps surae intramuscular fat content(Baseline to 3-month follow-up)
- Change in maximal plantar flexor strength(Baseline to 3-month follow-up)
- Change in diastolic blood pressure(Baseline to 3-month follow-up)
- Change in the time constant for phosphocreatine recovery after dynamic exercise(Baseline to 3-month follow-up)