Health TrialsbyHealthPanel

Leg Heat Therapy in Peripheral Artery Disease

ConditionPeripheral Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorIndiana University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Leg heat therapy

    Device

    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.

  • Sham Control

    Device

    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.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Heat therapyExperimental treatment 1 intervention
Group B: Sham ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in 6-minute walk distance

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.

Time frame
Baseline to 3-month follow-up

Secondary outcomes

1

Change in Walking Impairment Questionnaire (WIQ) score

This disease-specific questionnaire assess the ability of patients with PAD to walk defined distances and speeds and to climb stairs, with scores ranging from 0 to 100. Higher scores are reflective of better community-based walking ability. The investigators will determine whether leg heat therapy improves the WIQ score at 3-month follow-up compared to the sham treatment.

Time frame
Baseline to 3-month follow-up
2

Change in Short-Form (SF)-36 Questionnaire score

Health-related quality of life (HRQOL) will be assessed using the short-form SF-36 questionnaire, which is composed of 8 subscales. Each subscale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. The investigators will determine whether leg heat therapy improves the SF-36 score at 3-month follow-up compared to the sham treatment.

Time frame
Baseline to 3-month follow-up
3

Change in Short Physical Performance Battery (SPPB) score

The SPPB combines data from the usual paced 4-m walking velocity, time to rise from a seated position 5 times, and standing balance. The timed results of the subtests will be converted to an ordinal scale ranging from 0 (worst performance) to 12 (best performance). The investigators will determine whether leg heat therapy improves the SPPB score at 3-month follow-up compared to the sham treatment.

Time frame
Baseline to 3-month follow-up
4

Change in handgrip strength

The assessment of maximal handgrip strength will be will performed using a hand dynamometer. The investigators will determine whether leg heat therapy improves handgrip strength at 3-month follow-up compared to the sham treatment.

Time frame
Baseline to 3-month follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Purdue University

Collaborator

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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