72 Participants Needed

Heat Therapy for Limited Mobility

SR
AM
Overseen ByAmy Moore, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

To test the hypothesis that home-based leg heat therapy improves functional capacity, vascular function, and exercise hyperemia in older adults.

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.

Is heat therapy safe for humans?

Research indicates that heat therapy, including home-based leg heat therapy, is generally safe and well-tolerated in humans. Studies have shown it can improve physical function and reduce blood pressure without significant adverse effects.12345

How does home-based leg heat therapy differ from other treatments for limited mobility?

Home-based leg heat therapy is unique because it uses water-circulating trousers to apply heat to the legs, which can be done at home without supervision. This method is practical and painless, and it has been shown to improve walking ability in patients with peripheral artery disease, making it a novel option compared to other noninvasive treatments.26789

What data supports the effectiveness of the treatment Heat Therapy for Limited Mobility?

Research shows that heat therapy is effective in managing lymphoedema (swelling due to fluid build-up), as it is a well-known conservative treatment. Additionally, a study combining heat with other therapies for lymphedema showed significant improvement in leg swelling, suggesting potential benefits of heat therapy for similar conditions.810111213

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
See 4 more

Exclusion Criteria

History of anaphylaxis
Severe phobia of needles
Known allergies or sensitivities to drugs used in the study
See 29 more

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?
2Treatment groups
Experimental Treatment
Group I: Home-based heat therapy and vascular function and exercise hyperemia in older adultsExperimental Treatment2 Interventions
Group II: Home-based heat therapy and functional capacity in older adultsExperimental Treatment2 Interventions

Find a Clinic Near You

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

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.
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]
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.
Simple and effective method of heat therapy in lymphoedema.Kulkarni, AA., Abhyankar, SV., Chaudhari, GS., 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.
Approaches to the application and removal of compression therapy: A literature review.Balcombe, L., Miller, C., McGuiness, W.[2019]

Citations

Online coaching for a lower limb physical activity program for individuals at home with a history of venous ulcers. [2018]
Simple and effective method of heat therapy in lymphoedema. [2021]
Approaches to the application and removal of compression therapy: A literature review. [2019]
Treatment of peripheral lymphedema by concomitant application of magnetic fields, vibration and hyperthermia: a preliminary report. [2006]
[Therapeutic effect of heating and bandage treatment for chronic lymphedema of extremities accompanied with erysipelas: a report of 80 cases]. [2022]
Sauna as a valuable clinical tool for cardiovascular, autoimmune, toxicant- induced and other chronic health problems. [2022]
Effects of home-based leg heat therapy on walking performance in patients with symptomatic peripheral artery disease: a pilot randomized trial. [2023]
The effect of heat therapy on blood pressure and peripheral vascular function: A systematic review and meta-analysis. [2022]
Antihypertensive Effects of Three Days of Leg Bathing on a Patient With Stanford Type A Acute Aortic Dissection After Surgery: A Case Report. [2023]
10.United Statespubmed.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. [2021]
Application of heat and a home exercise program for pain and function levels in patients with knee osteoarthritis: A randomized controlled trial. [2020]
A systematic review of the role of heat therapy for patients with intermittent claudication due to peripheral artery disease. [2022]
13.United Statespubmed.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. [2018]
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