Effects of Heating on Exercise Pressor Reflex in Peripheral Artery Disease: Exercise Ability
Key facts
- Who runs it
- Milton S. Hershey Medical Center
- Where
- Hershey, United StatesSee the site
- Trial code
- Status
- Completed
- Phase
- Early phase 1
- People taking part
- 33 people enrolled
- Started
- 15 May 2019
- Ended
- 31 Jul 2025
- Type of study
- Interventional, 10 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Without Heating
- Warm Bath
- Neutral Bath
- Heating Suit
- Lower limb warm water immersion
- Gardner walking protocol
- Record updated
- 16 September 2025
Who can take part
- Age
- 21 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- Decisional impairment
- 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)
- Age < 21 years
- For patients with PAD and Healthy subjects
- Pregnant or nursing women
- Prisoners; For patients with PAD
Where in United States
- Penn State Milton S. Hershey Medical CenterHershey, United States
About the trial
What the trial wants to find out
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.
The 10 groups in the trial
- PAD without heatingPlacebo, for comparison
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.
Treatment: Without Heating and Gardner walking protocol
- PAD warm bathTreatment being tested
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.
Treatment: Warm Bath and Gardner walking protocol
- PAD neutral bathPlacebo, for comparison
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.
Treatment: Neutral Bath and Gardner walking protocol
- PAD heating suitTreatment being tested
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.
Treatment: Heating Suit and Gardner walking protocol
- PAD lower limb warm water immersionTreatment being tested
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.
Treatment: Lower limb warm water immersion and Gardner walking protocol
- Healthy subjects without heatingPlacebo, for comparison
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.
Treatment: Without Heating and Gardner walking protocol
- Healthy subjects warm bathTreatment being tested
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.
Treatment: Warm Bath and Gardner walking protocol
- Healthy subjects neutral bathPlacebo, for comparison
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.
Treatment: Neutral Bath and Gardner walking protocol
- Healthy subjects heat suitTreatment being tested
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.
Treatment: Heating Suit and Gardner walking protocol
- Healthy subjects lower limb immersionTreatment being tested
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.
Treatment: Lower limb warm water immersion and Gardner walking protocol
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 16 September 2025