Heat Therapy for Limited Mobility

Overseen By Amy Moore, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of North Texas Health Science Center

Must not be taking: Anti-hypertensives, Beta blockers, Anticoagulants, Hormones

Disqualifiers: Cancer, Cardio-metabolic, Respiratory, Neurological, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using heat therapy at home on the legs can help older adults improve movement and blood flow. Researchers aim to determine if this therapy can enhance walking distance and improve blood vessel function. The trial seeks older adults who do not smoke, have normal blood pressure, and are not on specific medications that affect blood flow. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking health advancements.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications, including anti-hypertensive medications, beta blockers, bronchodilators, anti-coagulant therapy, and hormone replacement therapy. Additionally, participants must abstain from prescription or non-prescription medications 24 hours before the experimental session unless cleared by the medical screener.

What prior data suggests that home-based leg heat therapy is safe for older adults?

Research has shown that older adults generally handle home-based leg heat therapy well. This therapy uses special trousers that circulate warm water and can be safely used at home without supervision. One study found that after eight weeks of using this therapy, participants had lower daytime blood pressure and improved blood vessel function. These findings suggest the therapy is safe and may offer additional health benefits. So far, studies have reported no major negative side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about home-based leg heat therapy for older adults with limited mobility because it offers a non-invasive and easily accessible way to boost physical function and vascular health. Unlike traditional physical rehabilitation methods that require supervised exercise sessions, this treatment can be done at home, making it more convenient for older adults who may have difficulty traveling or engaging in strenuous exercise. Moreover, the therapy aims to enhance blood flow and improve vascular function, addressing cardiovascular risks directly, which are often overlooked by standard mobility treatments. By improving both functional capacity and vascular health, this therapy has the potential to provide comprehensive benefits that go beyond what current options offer.

What evidence suggests that home-based leg heat therapy could be effective for improving functional capacity and vascular function in older adults?

Research has shown that using heat therapy at home can help older adults walk better and improve their physical abilities. In this trial, participants will receive either home-based leg heat therapy or a sham intervention. Wearing special trousers that circulate warm water as part of the heat therapy has led to noticeable improvements in walking distance, an important sign of mobility. This therapy is safe and easy to use, making it a good option for those with movement difficulties. It also enhances the feeling of capability, which can ease daily life for older adults with mobility issues. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for post-menopausal women aged 55 to 80 with a BMI under 35 (unless athletic), normal blood pressure, and no recent tobacco use. They must have a healthy heart rhythm and general health. Exclusions include certain medication uses, respiratory illnesses, history of severe allergies or clotting issues, cancer diagnosis, cardiovascular abnormalities, latex allergy, leg or arm skin issues.

Inclusion Criteria

Normal clinical results from a medical exam reviewed by a board-certified physician

I am between 55 and 80 years old.

No tobacco/nicotine use within preceding 6 months

Exclusion Criteria

History of anaphylaxis

Severe phobia of needles

I have had issues with the blood vessels in my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo home-based leg heat therapy to improve functional capacity and vascular function

8 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Home-based leg heat therapy
• Home-based sham therapy

Trial Overview

The study investigates if applying heat therapy at home to the legs can improve walking ability, blood vessel health, and the body's response to exercise in older adults. Participants will either receive real heat treatment or a sham (fake) therapy as a comparison.

How Is the Trial Designed?

Group I: Home-based heat therapy and vascular function and exercise hyperemia in older adults Experimental Treatment 2 Interventions

The investigators will determine if home-based leg heat therapy improves vascular function and exercise hyperemia in the older adults of Aim 1. Using state-of-the-art techniques of skeletal muscle microdialysis and high-resolution duplex ultrasound, the investigators will pharmacodissect mechanisms of vascular function and exercise hyperemia before and after each intervention. The outcomes of Aim 2, while providing insight into the mechanisms whereby heat therapy improves functional capacity, should be considered independent of the outcomes of Aim 1 given that vascular health is a key independent, yet modifiable risk factor for cardiovascular morbidity and mortality.

Group II: Home-based heat therapy and functional capacity in older adults Experimental Treatment 2 Interventions

The investigators will determine the extent to which home-based leg heat therapy improves functional capacity in older adults. Functional capacity will be assessed before and after heat therapy or sham intervention via the 6-min walk test and the Short Physical Performance Battery.

Who Is Running the Clinical Trial?

University of North Texas Health Science Center

Lead Sponsor

Trials

41

Recruited

20,800+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

Regular sauna therapy is generally safe and provides various health benefits, particularly for individuals with conditions like hypertension, heart failure, and chronic pain, based on historical and contemporary studies.

However, caution is advised for pregnant individuals, as high temperatures from sauna use may pose risks to fetal development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sauna as a valuable clinical tool for cardiovascular, autoimmune, toxicant- induced and other chronic health problems. Crinnion, WJ.[2022]

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]

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]

Compression therapy is essential for treating venous disorders and lymphoedema, but many patients struggle with adherence due to difficulties in applying and removing compression garments.

The review identified four effective methods to improve adherence: using application devices, redesigning compression stockings, adjustable wraps, and providing education on proper use, highlighting the importance of support for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches to the application and removal of compression therapy: A literature review. Balcombe, L., Miller, C., McGuiness, W.[2019]

A study of 80 patients with chronic lymphedema and erysipelas showed that heating treatment combined with bandage therapy significantly reduced the frequency of erysipelas occurrences, with 75% of patients experiencing no further episodes after treatment.

The treatment not only decreased erysipelas relapses but also improved patients' quality of life, highlighting the importance of continued use of elastic materials for pressure therapy post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic effect of heating and bandage treatment for chronic lymphedema of extremities accompanied with erysipelas: a report of 80 cases]. Li, K., Liu, N., Fu, L., et al.[2022]

Heat therapy, specifically whole-body immersion, significantly improved walking distance and ankle-brachial pressure indices in patients with intermittent claudication, based on a systematic review of three randomized controlled trials.

Despite these improvements, no heat therapy method showed significant benefits in quality of life or brachial blood pressure, highlighting the need for further research to standardize heat therapy protocols and assess their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the role of heat therapy for patients with intermittent claudication due to peripheral artery disease. Harwood, AE., Pugh, CJ., Steward, CJ., et al.[2022]

The study introduces a cost-effective and easy-to-make heat therapy apparatus for managing lymphoedema, highlighting its practicality and transportability.

This heat therapy method has been found to be very effective, suggesting it could be a valuable tool for patients seeking conservative treatment options for lymphoedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simple and effective method of heat therapy in lymphoedema. Kulkarni, AA., Abhyankar, SV., Chaudhari, GS., et al.[2021]

A preliminary study tested a home-based physical activity intervention for patients with a history of leg ulcers, using a 'live' coach via the Internet, which proved to be feasible and acceptable to patients.

The intervention involved a 10- to 15-minute lower limb exercise protocol, indicating that structured online coaching can effectively support patients in improving their physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online coaching for a lower limb physical activity program for individuals at home with a history of venous ulcers. Kelechi, TJ., Green, A., Dumas, B., 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 case study of a 50-year-old woman recovering from aortic dissection, leg bathing at 42°C for 20 minutes significantly reduced her hypertension, demonstrating an effective non-pharmacological intervention.

After three days of leg bathing, her blood pressure improved from an average of 151/94 mmHg at rest to 137/81 mmHg, indicating that thermal therapy can have a beneficial antihypertensive effect post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antihypertensive Effects of Three Days of Leg Bathing on a Patient With Stanford Type A Acute Aortic Dissection After Surgery: A Case Report. Takahashi, Y., Hasegawa, K., Okura, K.[2023]

In a study of 62 patients with bilateral knee osteoarthritis, applying superficial local heat and engaging in a home exercise program led to significant reductions in pain and improved function compared to a control group receiving only routine treatment.

While all intervention groups showed improvements, the exercise group experienced the most notable decrease in pain and stiffness, suggesting that exercise may be particularly beneficial for managing osteoarthritis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of heat and a home exercise program for pain and function levels in patients with knee osteoarthritis: A randomized controlled trial. Karadağ, S., Taşci, S., Doğan, N., et al.[2020]

In a study of 50 patients with chronic knee pain, the use of low level continuous heat (LLCH) wraps significantly reduced pain and improved knee strength and range of motion compared to a placebo treatment over a 2-week period.

Patients using LLCH also showed better compliance with home exercise routines, indicating that LLCH not only aids recovery but also encourages patients to engage more in their rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Low Level of Continuous Heat as an Adjunct to Physical Therapy Improves Knee Pain Recovery and the Compliance for Home Exercise in Patients With Chronic Knee Pain: A Randomized Controlled Trial. Petrofsky, JS., Laymon, MS., Alshammari, FS., et al.[2018]

In a preliminary trial involving 10 patients with unilateral leg lymphedema, a combined therapy using magnetic fields, vibration, and hyperthermia over 20 days resulted in significant improvements, with 8 patients showing highly effective outcomes.

The treatment led to the volume of the affected leg nearly matching that of the healthy leg in 6 cases, indicating strong efficacy, although one patient experienced temporary skin erythema, which resolved on its own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of peripheral lymphedema by concomitant application of magnetic fields, vibration and hyperthermia: a preliminary report. Ohkuma, M.[2006]

Citations

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This study represents the first step in developing a portable leg heating system for elderly patients with PAD, demonstrating that home-based leg HT is ...

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This pilot trial demonstrates the feasibility of unsupervised, home-based leg heat therapy using water-circulating trousers in older adults.

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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 ...

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pmc.ncbi.nlm.nih.gov

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

Leg heat therapy improves perceived physical function but ...

Our findings revealed that HT applied with water-circulating trousers evokes a clinically meaningful increase in perceived physical function and reduces the ...

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NCT03763331 | Home-based Leg Heat Therapy

Outcome Measures · Change in Treadmill Peak Walking Time [Time Frame: 8 weeks] · Change in Peak Calf Blood Flow [Time Frame: 8 weeks] · Change in Leg Cutaneous ...

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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.

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Feasibility of unsupervised, home-based leg heat therapy in ...

Secondary outcomes included 6-minute walk distance, sit-to-stand time, plantar flexor strength, MRI-derived muscle morphology, quality of life, ...