CompletedEarly Phase 1

Effects of Heating on Exercise Pressor Reflex in Peripheral Artery Disease: Exercise Ability

United States33 participantsStarted 2019-05-15

Plain-language summary

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.

Who can participate

Age range

21 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: All subjects * Capable of giving informed consent * Any race or ethnicity * Men and women age 21- 85 years (inclusive) * Fluent in written and spoken English Patients with peripheral arterial disease (PAD) * Diagnosed with PAD (i.e., ankle-brachial index below 0.9) * Fontaine stage II or less - no pain while resting * Satisfactory history and physical exam Healthy subjects * Satisfactory history and physical examination * Free of acute medical conditions Exclusion Criteria: For patients with PAD and Healthy subjects * Age \< 21 years * Pregnant or nursing women * Decisional impairment * Prisoners For patients with PAD * History of CAD with symptoms of unstable angina or myocardial infarction (\<6 months) * History of epilepsy or seizure disorders For healthy subjects • Any other chronic diseases (heart, lung, neuromuscular disease or diabetes)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Walking time in minutes

Timeframe: Recording walking time to fatigue (up to 22 minutes maximum) during of every 3-4 hour study visit.

Blood pressure in mmHg

Timeframe: Recorded continuously during the 3-4 hour study visit

Heart Rate in beats per minute

Timeframe: Recorded continuously during the 3-4 hour study visit

Trial details

NCT IDNCT03900832

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More PAD trials

Who can participate

Age range

21 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Walking time in minutes

Timeframe: Recording walking time to fatigue (up to 22 minutes maximum) during of every 3-4 hour study visit.

Blood pressure in mmHg

Timeframe: Recorded continuously during the 3-4 hour study visit

Heart Rate in beats per minute

Timeframe: Recorded continuously during the 3-4 hour study visit