Leg Heat Therapy for Peripheral Artery Disease
This study is testing whether a home-based leg heat therapy can improve walking ability and quality of life for people with peripheral artery disease (PAD). PAD is a condition where narrowed arteries reduce blood flow to your limbs. You would wear special trousers that circulate warm water (42ºC) for 90 minutes daily over three months. Another group will receive a "sham" treatment where the water is less warm (33ºC). The study aims to enroll 106 participants aged 50 and older who have been diagnosed with PAD based on their ankle-brachial index (ABI) scores. Success will be measured by how much your walking distance improves over 6 minutes after 12 weeks of therapy.
- Study design
- This is a randomized, double-blind, sham-controlled study involving 106 participants. Participants will be assigned by chance to either the leg heat therapy or the sham control group, and neither you nor the researchers will know which treatment you are receiving.
- What's involved
- You would apply the leg heat therapy daily for 90 minutes for three consecutive months. Outcomes will be assessed at the start, at the end of the 12-week treatment period, and at a follow-up visit 12 weeks later.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be checked at the end of the 12-week treatment and again 12 weeks after the treatment ends.
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Leg Heat Therapy in Peripheral Artery Disease
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Change in 6-minute walk distanceBaseline 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.