Effects of heat on exercise responses in patients with peripheral artery disease
Effects of Heating on Exercise Pressor Reflex in Peripheral Artery Disease: Exercise Ability
This study tests if warming up with things like warm baths or heating suits can help people with peripheral artery disease exercise better by seeing how it affects their blood pressure and muscle responses.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT03900832 on ClinicalTrials.gov |
What this trial studies
This study investigates how heat exposure affects the sympathetic and blood pressure responses during exercise in patients with peripheral artery disease (PAD). It aims to determine if heating alters the sensitivity of muscle afferent receptors, potentially improving exercise tolerance. Participants will undergo various interventions, including warm baths and heating suits, to assess their impact on exercise-induced blood pressure responses. The study focuses on patients diagnosed with PAD, particularly those experiencing intermittent claudication during physical activity.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21-85 diagnosed with peripheral artery disease and experiencing intermittent claudication.
Not a fit: Patients with advanced cardiovascular conditions or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance exercise tolerance and overall quality of life for patients with peripheral artery disease.
How similar studies have performed: Previous studies have indicated that exercise can benefit PAD patients, but this specific approach of using heat exposure is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Hershey, Pennsylvania
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jian Cui — Penn State College of Medicine
- Study coordinator: Jian Cui, PhD
- Email: jcui@pennstatehealth.psu.edu
- Phone: 7175311799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.