Leg Heat Therapy for Heart Failure

Recruiting at 1 trial location

Overseen By Doris Muriathiri, MPH, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Recent hospitalization, Unstable angina, Renal disease, 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: Unknown

Duration: 8 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this pilot study is to establish evidence to support the validity of HT in improving skeletal muscle function and physical capacity of patients with HFpEF. Our central hypothesis is that HT treatment will lead to improvements in skeletal muscle and microvascular function compared to a control intervention. As a result, we anticipate that patients treated with HT will demonstrate improved skeletal muscle microvascular blood flow and oxygenation resulting in enhanced exercise tolerance. To explore this hypothesis, we propose the following specific aim: Explore the effects of home-based HT on exercise tolerance in patients with HFpEF.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should have stable medical treatment. This suggests you may need to continue your current medications as they are.

What data supports the effectiveness of Leg Heat Therapy for heart failure?

Research suggests that heat therapy, including leg heat therapy, can improve heart function and sleep quality in heart failure patients. Additionally, similar heat treatments have shown benefits in improving walking performance in patients with peripheral artery disease. ^{1 2 3 4 5}

How does Leg Heat Therapy differ from other treatments for heart failure?

Leg Heat Therapy is unique because it uses topical heat applied to the legs to improve heart function and sleep quality in heart failure patients, offering a simple, non-invasive, and home-based approach compared to traditional drug therapies. ^{1 3 4 6 7}

Eligibility Criteria

This trial is for men and women over 18 with heart failure where the heart's main pumping chamber still pumps well (HFpEF). They must have had certain tests showing this condition, like an echocardiogram or elevated NT-pro-BNP levels, and be on stable medications.

Inclusion Criteria

I am older than 18 years.

My current medical treatment has not changed recently.

I have heart failure with a normal pump function confirmed by tests.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily leg heat therapy for 90 minutes using water-circulating trousers perfused with water heated to 42ºC or a sham treatment with water heated to 33ºC

8 weeks

Follow-up

Participants are monitored for changes in exercise tolerance, muscle function, and cardiovascular parameters

8 weeks

Treatment Details

Interventions

• Leg Heat Therapy

Trial Overview The study is testing leg heat therapy to see if it improves muscle function and exercise ability in patients with HFpEF. Participants will receive either actual heat therapy or a sham (fake) treatment as a control to compare results.

Participant Groups

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 in the supine position.

Group II: Sham control Placebo Group 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+

Findings from Research

Heat therapy, including methods like dry heat and water immersion, has shown beneficial effects in patients with heart failure, suggesting it could be a valuable complementary treatment alongside traditional medications and devices.

The authors propose using topically applied heat pads as a simple and cost-effective way to deliver heat therapy, encouraging further research into its potential as an adjunctive care option for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heat therapy in the management of heart failure. Weber, AA., Silver, MA.[2019]

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]

In a study involving 18 patients with stable chronic heart failure, leg thermal therapy (LTT) significantly improved subjective sleep quality, including deeper sleep and longer sleep duration, over three nights of treatment.

Objective measures also confirmed these improvements, showing a decrease in light sleep (N1) and an increase in deeper sleep (N2), suggesting that LTT could be an effective complementary therapy for enhancing sleep quality in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three nights leg thermal therapy could improve sleep quality in patients with chronic heart failure. Sawatari, H., Nishizaka, MK., Miyazono, M., et al.[2018]

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]

In a preliminary study of 4 male patients with dilated cardiomyopathy and chronic heart failure, a steam foot bath significantly increased sublingual temperature and improved endothelial function, suggesting potential benefits for heart health.

While blood pressure, heart rate, and ventricular arrhythmias remained unchanged, there was a trend towards reduced mitral regurgitation, indicating that steam foot baths may be a safe and supportive therapy for patients awaiting heart transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Appendicular thermal therapy for heart failure]. Komamura, K.[2011]

In a study involving 114 patients with severe chronic heart failure, long-term home oxygen therapy (LTOT) for at least 15 hours a day did not show a significant improvement in quality of life compared to best medical therapy, as measured by the Minnesota Living with Heart Failure questionnaire at 6 months.

Although there was a temporary improvement in breathlessness scores at 3 months for the LTOT group, this effect did not last, and adherence to the oxygen therapy was low, with only 11% of patients using it as prescribed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does home oxygen therapy (HOT) in addition to standard care reduce disease severity and improve symptoms in people with chronic heart failure? A randomised trial of home oxygen therapy for patients with chronic heart failure. Clark, AL., Johnson, M., Fairhurst, C., et al.[2021]

A single sauna session was well tolerated by 8 male heart transplant patients (average age 42), showing promising effects on cardiovascular health during their rehabilitation phase.

The sauna therapy led to significant improvements, including lower blood pressure, enhanced microcirculation in small vessels, increased left ventricular ejection fraction (LVEF), and reduced total peripheral vascular resistance (TPVR).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Circulatory changes in acute sauna hyperthermia after heart transplantation]. Winterfeld, HJ., Siewert, H., Engelmann, U., et al.[2007]

References

1. United States pubmed.ncbi.nlm.nih.gov

Heat therapy in the management of heart failure. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Acute Lower Leg Heating Increases Exercise Capacity in Patients With Peripheral Artery Disease. [2020]

3. Japan pubmed.ncbi.nlm.nih.gov

Three nights leg thermal therapy could improve sleep quality in patients with chronic heart failure. [2018]

4. United States 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. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

[Appendicular thermal therapy for heart failure]. [2011]

6. England pubmed.ncbi.nlm.nih.gov

Does home oxygen therapy (HOT) in addition to standard care reduce disease severity and improve symptoms in people with chronic heart failure? A randomised trial of home oxygen therapy for patients with chronic heart failure. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

[Circulatory changes in acute sauna hyperthermia after heart transplantation]. [2007]