32 Participants Needed

Heating Treatments for Peripheral Artery Disease

(EPR Trial)

JC
KG
Overseen ByKris Gray, MS
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Milton S. Hershey Medical Center

Trial Summary

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

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment for Peripheral Artery Disease?

Research shows that heat therapy, such as heated-water exercise and home-based leg heating, can improve walking distance and reduce blood pressure in patients with Peripheral Artery Disease (PAD). These therapies are well-tolerated and can enhance exercise tolerance and quality of life, making them a promising alternative or complement to traditional exercise programs.12345

Is heat therapy safe for humans with peripheral artery disease?

Heat therapy, such as hot-water immersion and heated-water exercise, has been well tolerated and shown to be safe in studies involving patients with peripheral artery disease. Participants adhered well to the treatment, and no significant safety concerns were reported.23678

How does the No Heat Treatment for Peripheral Artery Disease differ from other treatments?

The No Heat Treatment, or Standard Exercise Protocol, for Peripheral Artery Disease (PAD) involves supervised exercise without additional heating elements. Unlike heat therapies that use hot-water immersion or heated garments to improve blood flow and reduce symptoms, this approach focuses solely on traditional exercise to enhance walking ability and cardiovascular health.12378

What is the purpose of this trial?

The study objectives of this projects are to examine the hypothesis that the sympathetic and blood pressure responses to exercise will be attenuated during and after heat exposure in patients with peripheral artery disease, via altering the sensitivity of the muscle afferent receptors.

Research Team

JC

Jian Cui

Principal Investigator

Penn State College of Medicine

Eligibility Criteria

This trial is for men and women aged 21-85 with Peripheral Artery Disease (PAD), specifically those who can consent, speak English, have an ankle-brachial index below 0.9 without rest pain, and are generally healthy otherwise. It excludes pregnant or nursing women, individuals under 21 or with decisional impairments, prisoners, and those with other chronic diseases or recent severe cardiac events.

Inclusion Criteria

I have been diagnosed with peripheral artery disease (PAD).
Any race or ethnicity
I do not have any current severe illnesses.
See 6 more

Exclusion Criteria

Pregnant or nursing women
I have difficulty making decisions due to a mental condition.
I have had heart issues like unstable angina or a heart attack in the last 6 months.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo various heating interventions followed by treadmill walking using the Gardner protocol. BP, HR, and NIRS are continuously measured.

3-4 hours per visit
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Gardner walking protocol
  • Heating Suit
  • Lower limb warm water immersion
  • Neutral Bath
  • Warm Bath
  • Without Heating
Trial Overview The study tests if heating methods like a heating suit or warm water immersion before exercise can reduce the sympathetic nervous system's response in PAD patients. The hypothesis suggests that heat may make muscle receptors less sensitive to stress from exercise.
Participant Groups
10Treatment groups
Experimental Treatment
Placebo Group
Group I: PAD warm bathExperimental Treatment2 Interventions
Subjects will take a warm bath. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group II: PAD lower limb warm water immersionExperimental Treatment2 Interventions
Subjects will place their lower legs in warm water. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group III: PAD heating suitExperimental Treatment2 Interventions
Whole body heating with the suit will be performed. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group IV: Healthy subjects warm bathExperimental Treatment2 Interventions
Subjects will take a warm bath. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group V: Healthy subjects lower limb immersionExperimental Treatment2 Interventions
Subjects will place their lower legs in warm water. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group VI: Healthy subjects heat suitExperimental Treatment2 Interventions
Whole body heating with the suit will be performed. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group VII: Healthy subjects without heatingPlacebo Group2 Interventions
Subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group VIII: Healthy subjects neutral bathPlacebo Group2 Interventions
Subjects will take a neutral bath. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group IX: PAD without heatingPlacebo Group2 Interventions
Subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group X: PAD neutral bathPlacebo Group2 Interventions
Subjects will take a neutral bath. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials
515
Recruited
2,873,000+

Findings from Research

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.
Acute Lower Leg Heating Increases Exercise Capacity in Patients With Peripheral Artery Disease.Pellinger, TK., Neighbors, CB., Simmons, GH.[2020]
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.
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]
Heated-water exercise therapy (HWET) showed significantly greater improvements in cardiovascular function, exercise tolerance, and body composition compared to land-based exercise therapy (LBET) in patients with peripheral artery disease (PAD), based on a study of 53 participants over 12 weeks.
Both HWET and LBET effectively reduced arterial stiffness and blood pressure, but HWET resulted in better outcomes for walking distance and claudication onset time, suggesting it may enhance quality of life more effectively for PAD patients.
Effects of heated water-based versus land-based exercise training on vascular function in individuals with peripheral artery disease.Park, SY., Wong, A., Son, WM., et al.[2022]

References

Acute Lower Leg Heating Increases Exercise Capacity in Patients With Peripheral Artery Disease. [2020]
Heat therapy vs. supervised exercise therapy for peripheral arterial disease: a 12-wk randomized, controlled trial. [2020]
Effects of heated water-based versus land-based exercise training on vascular function in individuals with peripheral artery disease. [2022]
Effects of home-based leg heat therapy on walking performance in patients with symptomatic peripheral artery disease: a pilot randomized trial. [2023]
Exercise Rehabilitation for Peripheral Artery Disease: A REVIEW. [2019]
Heat therapy improves body composition and muscle function but does not affect capillary or collateral growth in a model of obesity and hindlimb ischemia. [2022]
Leg heat therapy improves perceived physical function but does not enhance walking capacity or vascular function in patients with peripheral artery disease. [2021]
Heat treatment improves the exaggerated exercise pressor reflex in rats with femoral artery occlusion via a reduction in the activity of the P2X receptor pathway. [2021]
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