Leg Heat Therapy for Peripheral Arterial Disease

Overseen By Kimmy Marshall, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Critical limb ischemia, Amputation, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

106 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether heat therapy on the legs can improve walking ability and quality of life for people with peripheral artery disease (PAD), a condition that affects blood flow to the legs. Participants will receive either the leg heat therapy or a similar treatment with less heat (sham control) to compare effects. The main focus is on the distance participants can walk in six minutes before and after 12 weeks of treatment. People with PAD who experience leg pain or fatigue when walking might be a good fit for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance treatment options for PAD.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that leg heat therapy is safe for patients with peripheral arterial disease?

Research has shown that leg heat therapy is safe and well-tolerated for people with peripheral artery disease (PAD). One study demonstrated that using water-filled trousers for heat therapy at home improved walking ability without major safety issues. Another review found that heat therapy increased blood flow in the legs, benefiting those with PAD. These findings suggest that leg heat therapy is not only safe but could also enhance physical function in individuals with PAD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Leg Heat Therapy for Peripheral Arterial Disease (PAD) is unique because it offers a non-invasive and drug-free approach to managing the condition. Unlike standard treatments for PAD, which often include medications like antiplatelets or statins and invasive procedures such as angioplasty, this therapy uses heat to improve blood flow. Researchers are excited about this treatment because it leverages water-circulating trousers to deliver consistent warmth at 42ºC, potentially enhancing circulation in the legs without the risks associated with surgery or medication side effects. This innovative approach could offer a safer and more comfortable option for patients with PAD.

What evidence suggests that leg heat therapy might be an effective treatment for peripheral artery disease?

This trial will compare Leg Heat Therapy with a Sham Control for individuals with peripheral artery disease (PAD). Research has shown that heat therapy on the legs might improve physical comfort for people with PAD. Studies have found that regular use of this therapy can enhance patients' perceived physical capability, even though it doesn't seem to improve actual walking ability or blood flow. The therapy uses special trousers that circulate warm water to apply heat, potentially improving overall quality of life. New evidence suggests this therapy could be a practical and helpful way to manage PAD symptoms. However, more research is needed to fully understand its effects on walking and blood vessel health. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for men and women over 60 with lower-extremity peripheral artery disease (PAD), evidenced by a low ankle-brachial index. It's not for those with critical limb ischemia, other conditions limiting exercise tolerance, recent leg surgeries, use of walking aids besides a cane, severe kidney disease or obesity, inability to wear water-circulating trousers, certain mental impairments or thermal sensation issues in the legs.

Inclusion Criteria

My leg circulation test shows poor blood flow.

I am older than 60 years.

Exclusion Criteria

I have had a foot or leg amputation.

I have severe leg pain at rest or wounds that won't heal due to poor blood flow.

I use a walking aid that is not a cane.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily leg heat therapy or sham treatment for 90 minutes over 12 weeks

12 weeks

Home-based, unsupervised

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person) at week 24

What Are the Treatments Tested in This Trial?

Interventions

• Leg Heat Therapy
• Sham Control

Trial Overview The study tests if home-based leg heat therapy improves walking ability and quality of life in PAD patients compared to a sham control. Participants are randomly assigned to either real heat treatment or fake (sham) intervention and followed up after 12 weeks to measure changes in walk distance and various health scores.

How Is the Trial Designed?

Group I: Heat therapy Experimental Treatment 1 Intervention

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.

Group II: Sham Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Purdue University

Collaborator

Trials

239

Recruited

72,200+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A pilot study involving 34 patients with symptomatic peripheral artery disease (PAD) found that unsupervised, home-based leg heat therapy significantly improved walking performance, with a notable increase in the 6-minute walk distance after 8 weeks compared to a sham treatment.

The leg heat therapy was shown to be safe and well-tolerated, suggesting it could be a practical and painless adjunctive treatment to enhance physical function in patients with PAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of home-based leg heat therapy on walking performance in patients with symptomatic peripheral artery disease: a pilot randomized trial. Monroe, JC., Pae, BJ., Kargl, C., et al.[2023]

A 6-week supervised leg heat therapy (HT) using water-circulating trousers did not improve walking distance or blood pressure in patients with peripheral artery disease (PAD), but it significantly enhanced perceived physical function and reduced serum endothelin-1 levels.

The study involved 32 PAD patients, with 30 completing the treatment, showing high adherence and good tolerance to HT, indicating its potential as a supportive therapy for improving quality of life in PAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leg heat therapy improves perceived physical function but does not enhance walking capacity or vascular function in patients with peripheral artery disease. Monroe, JC., Lin, C., Perkins, SM., et al.[2021]

In a study involving 16 patients with symptomatic peripheral artery disease (PAD), a single session of leg heat therapy (HT) significantly lowered systolic blood pressure and post-exercise levels of endothelin-1, a marker associated with vascular constriction.

While the primary outcome of peak walking time (PWT) showed a trend towards improvement after HT, indicating potential benefits for exercise performance in PAD patients, the difference was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of leg heat therapy on walking performance and cardiovascular and inflammatory responses to exercise in patients with peripheral artery disease. Monroe, JC., Song, Q., Emery, MS., et al.[2021]

In a pilot study involving 6 patients with peripheral artery disease (PAD), acute lower leg heating significantly increased blood flow in the popliteal artery, demonstrating a duration-dependent effect after treatment.

The 6-minute walk distance improved by 10% and 12% following 15 and 45 minutes of heating, respectively, indicating that even short heating sessions can enhance exercise capacity in PAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Lower Leg Heating Increases Exercise Capacity in Patients With Peripheral Artery Disease. Pellinger, TK., Neighbors, CB., Simmons, GH.[2020]

Heat therapy significantly reduces mean arterial, systolic, and diastolic blood pressure, as shown in a systematic review of 15 studies involving various healthy and clinical populations.

In addition to lowering blood pressure, heat therapy improves vascular function, indicated by enhanced flow-mediated dilatation, suggesting it could be a valuable tool for preventing and managing cardiovascular disease risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of heat therapy on blood pressure and peripheral vascular function: A systematic review and meta-analysis. Pizzey, FK., Smith, EC., Ruediger, SL., et al.[2022]

Heat therapy, involving spa bathing and calisthenics, improved walking distance and resting blood pressure in patients with peripheral arterial disease (PAD) over 12 weeks, showing excellent adherence and tolerance among participants.

Both heat therapy and traditional exercise led to similar improvements in functional ability, suggesting that heat therapy could be a viable alternative for PAD patients who struggle with conventional exercise due to pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heat therapy vs. supervised exercise therapy for peripheral arterial disease: a 12-wk randomized, controlled trial. Akerman, AP., Thomas, KN., van Rij, AM., et al.[2020]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2468428724002600

Development and feasibility testing of a new device for ... Emerging evidence suggests that regular heat therapy (HT) may improve cardiovascular and physical function in patients with PAD. However, the lack of accessible ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9448284/

Effects of home-based leg heat therapy on walking ... The goal of the present study was to test the hypothesis that unsupervised, home-based leg heat therapy (HT) using water-circulating trousers perfused with warm ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05465070

Leg Heat Therapy in Peripheral Artery Disease 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 ...

4. journals.physiology.org journals.physiology.org/doi/abs/10.1152/japplphysiol.00143.2022

Effects of home-based leg heat therapy on walking ... Leg heat therapy improves perceived physical function but does not enhance walking capacity or vascular function in patients with peripheral artery disease. J ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7792848/

Leg heat therapy improves perceived physical function but ... Leg heat therapy improves perceived physical function but does not enhance walking capacity or vascular function in patients with peripheral artery disease.

6. ahajournals.org ahajournals.org/doi/10.1161/atvb.41.suppl_1.117

Abstract 117: Effect Of Home-Based Leg Heat Therapy On ... Conclusions: These preliminary results suggest that home-based leg HT for 8 weeks promotes clinically meaningful changes in 6-minute walk ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8358540/

A systematic review of the role of heat therapy for patients ... Results suggest that whole-body immersion and a lower-body heated garment increased limb blood flow. Pellinger et al. and Thomas et al. reported that blood flow ...