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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether heat therapy for the legs can benefit individuals with a specific type of heart failure, where the heart pumps normally but doesn't fill with blood properly. The researchers aim to determine if warming the legs can enhance muscle function and exercise ability by increasing blood flow and oxygen to the muscles. Participants will use special water-circulating trousers at home to apply the leg heat therapy. Suitable candidates have heart failure with preserved ejection fraction (a condition where the heart pumps normally but struggles to fill), are on stable treatment, and can exercise safely. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve the quality of life for those with heart failure.

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 prior data suggests that Leg Heat Therapy is safe for heart failure patients?

Research has shown that using heat therapy (HT) on the legs may improve physical function without serious safety issues. In studies involving individuals with conditions like poor blood flow in the legs or heart problems, HT has been generally well-received. Participants used the therapy daily and did not report any major side effects.

One study found that doing leg HT at home for eight weeks led to noticeable improvements in exercise ability. Although it didn't always enhance walking skills or blood vessel health, it did not harm participants.

Overall, leg heat therapy appears safe, with no major side effects found in studies so far. However, as with any treatment, it is important to follow the given instructions and consult a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for heart failure, which typically include medications like ACE inhibitors, beta-blockers, and diuretics, leg heat therapy offers a completely different approach. Researchers are excited about this technique because it uses water-circulating trousers to increase blood flow by warming the legs to 42ºC. This unique method could potentially improve heart function and circulation without the need for drugs. It's a novel, non-invasive way to manage heart failure symptoms, which could mean fewer side effects and an improved quality of life for patients.

What evidence suggests that Leg Heat Therapy is effective for heart failure?

Research shows that heat therapy, such as warming the legs, can improve heart function and sleep quality in people with heart failure. This trial will compare two approaches: one group will receive leg heat therapy with water heated to 42ºC, while the sham control group will receive therapy with water heated to 33ºC. Studies also indicate that performing this therapy at home can lower blood pressure and boost blood flow. For those with heart failure, warming the legs might also enhance blood circulation and increase exercise endurance. Although leg heat therapy has benefited other conditions, such as peripheral artery disease, it did not improve walking ability or blood vessel function in those cases. Overall, this therapy shows promise for enhancing physical function and exercise tolerance in heart failure patients. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 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 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

What Are the Treatments Tested in This Trial?

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.

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 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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

Citations

1. 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.

2. 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 ...

3. medicine.iu.edu medicine.iu.edu/blogs/cardiovascular/leg-heat-pilot-study-examines-blood-flow-and-exercise-endurance

Leg heat pilot study examines blood flow and exercise ... Leg heat pilot study examines how novel therapy may improve blood flow, exercise endurance in heart failure patients · Angie Antonopoulos.

4. withpower.com withpower.com/trial/phase-2-heart-failure-4-2024-18b8a

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 ...

5. journals.physiology.org journals.physiology.org/doi/10.1152/japplphysiol.00977.2024

Home-based heat therapy lowers blood pressure and ... This study determined that 8 wk of home-based lower body heat therapy reduced ambulatory daytime systolic blood pressure and increased flow-mediated dilation.

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/PMC12153253/

A controlled clinical trial of leg thermal therapy in ... This study aimed to investigate whether incorporating LTT into acute-phase CR confers exercise capacity in hospitalized patients with HF.