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Heating Treatments for Peripheral Artery Disease (EPR Trial)

Q: Are there any open slots in this research program for participants?

Affirmative. Evidenced by the information on clinicaltrials.gov, this experiment is currently looking for participants and was first published on May 15th 2019. The study necessitates 32 patients from a single medical site to participate in order to be completed successfully.

Q: Does the eligibility criteria of this trial encompass persons over thirty years old?

Applicants eligible for this medical study must be over 21 years old and not exceed the age of 85.

Q: What is the current enrollment figure for this medical trial?

Affirmative. The clinicaltrials.gov report attests that this research endeavour is currently enrolling participants, having been posted on May 15th 2019 and last updated January 10th 2022. 32 individuals are expected to be recruited from a single medical centre.

Q: To which demographic does the criteria for enrollment in this trial apply?

Eligibility for this trial requires that the patient has peripheral arterial disease and is between 21-85 years old. The team hopes to recruit approximately 32 individuals.

Phase < 1

Recruiting

Led By Jian Cui

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with PAD (i.e., ankle-brachial index below 0.9)

Capable of giving informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up recording walking time to fatigue (up to 22 minutes maximum) during of every 3-4 hour study visit.

Awards & highlights

EPR Trial Summary

This trial will study how heat exposure affects blood pressure and the sympathetic nervous system in patients with peripheral artery disease.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects might include discomfort due to heat exposure such as sweating or overheating during the use of heating suits or baths. There could also be skin irritation from prolonged contact with warm water.

EPR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with peripheral artery disease (PAD).

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I understand the study and can agree to participate.

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I don't have pain in my legs while resting.

EPR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ recording walking time to fatigue (up to 22 minutes maximum) during of every 3-4 hour study visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~recording walking time to fatigue (up to 22 minutes maximum) during of every 3-4 hour study visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and recording walking time to fatigue (up to 22 minutes maximum) during of every 3-4 hour study visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood pressure in mmHg

Heart Rate in beats per minute

Walking time in minutes

Secondary outcome measures

Thermography

Near infrared spectroscopy (NIRS) in arbitrary units

EPR Trial Design

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

Group V: Healthy subjects lower limb immersionExperimental Treatment2 Interventions

Group VI: Healthy subjects heat suitExperimental Treatment2 Interventions

Group VII: 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 VIII: 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 IX: PAD without heatingPlacebo Group2 Interventions

Group X: PAD neutral bathPlacebo Group2 Interventions

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

494 Previous Clinical Trials

2,798,810 Total Patients Enrolled

Jian CuiPrincipal InvestigatorPenn State College of Medicine

1 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

Without Heating Clinical Trial Eligibility Overview. Trial Name: NCT03900832 — Phase < 1

Peripheral Artery Disease Research Study Groups: Healthy subjects lower limb immersion, Healthy subjects warm bath, Healthy subjects heat suit, Healthy subjects neutral bath, Healthy subjects without heating, PAD without heating, PAD warm bath, PAD neutral bath, PAD heating suit, PAD lower limb warm water immersion

Peripheral Artery Disease Clinical Trial 2023: Without Heating Highlights & Side Effects. Trial Name: NCT03900832 — Phase < 1

Without Heating 2023 Treatment Timeline for Medical Study. Trial Name: NCT03900832 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots in this research program for participants?

"Affirmative. Evidenced by the information on clinicaltrials.gov, this experiment is currently looking for participants and was first published on May 15th 2019. The study necessitates 32 patients from a single medical site to participate in order to be completed successfully."

Answered by AI

Does the eligibility criteria of this trial encompass persons over thirty years old?

"Applicants eligible for this medical study must be over 21 years old and not exceed the age of 85."

Answered by AI

What is the current enrollment figure for this medical trial?

"Affirmative. The clinicaltrials.gov report attests that this research endeavour is currently enrolling participants, having been posted on May 15th 2019 and last updated January 10th 2022. 32 individuals are expected to be recruited from a single medical centre."

Answered by AI

To which demographic does the criteria for enrollment in this trial apply?

"Eligibility for this trial requires that the patient has peripheral arterial disease and is between 21-85 years old. The team hopes to recruit approximately 32 individuals."

Answered by AI

Recent research and studies

American Journal of Physiology-Regulatory, Integrative and Comparative PhysiologyJournal

Muscle Sympathetic Nerve Activity Response to Heat Stress Is Attenuated in Chronic Heart Failure Patients

Cui, Jian, John Boehmer, Cheryl Blaha, and Lawrence I. Sinoway. 2017. “Muscle Sympathetic Nerve Activity Response to Heat Stress Is Attenuated in Chronic Heart Failure Patients”. American Journal of Physiology-regulatory, Integrative and Comparative Physiology. American Physiological Society. doi:10.1152/ajpregu.00355.2016.

The Journal of PhysiologyJournal

Muscle Sympathetic Nerve Activity Responses to Dynamic Passive Muscle Stretch in Humans

Cui, Jian, Cheryl Blaha, Raman Moradkhan, Kristen S. Gray, and Lawrence I. Sinoway. 2006. “Muscle Sympathetic Nerve Activity Responses to Dynamic Passive Muscle Stretch in Humans”. The Journal of Physiology. Wiley. doi:10.1113/jphysiol.2006.116640.

Physiological ReportsJournal

Seasonal Variation in Muscle Sympathetic Nerve Activity

Cui, Jian, Matthew D. Muller, Cheryl Blaha, Allen R. Kunselman, and Lawrence I. Sinoway. 2015. “Seasonal Variation in Muscle Sympathetic Nerve Activity”. Physiological Reports. Wiley. doi:10.14814/phy2.12492.

Journal of Applied PhysiologyJournal