Heat therapy for older women with high blood pressure
Chronic Lower Leg Heating for the Treatment of Hypertension in Older Women
This study is testing if soaking legs in hot water can help older women with high blood pressure lower their numbers better than just taking their medication alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | Female |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT03857490 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of chronic heat therapy combined with antihypertensive medication in lowering blood pressure among older women with essential hypertension. Over six years, 500 participants will be screened, with 200 enrolled and 100 completing the study. Participants will be randomly assigned to either a heat therapy group, where they will immerse their legs in hot water, or a control group with thermoneutral water. The study aims to assess changes in blood pressure, vascular function, and patient adherence to treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 65-85 years with essential hypertension.
Not a fit: Patients with severe hypertension, cardiopulmonary disease, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide an effective non-pharmacological option for managing hypertension in older women.
How similar studies have performed: While the use of heat therapy is promising, this specific approach in hypertensive patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women between the ages of 65-85 years with essential hypertension (systolic BP 140-179 and/or diastolic BP 90-109 mmHg) * Must be able to understand and speak English Exclusion Criteria: * Illness or disabilities that preclude home-based heat therapy * Any evidence of cardiopulmonary disease * Severe hypertension (BP ≥180/110 mmHg; for safety reasons) * Secondary hypertension * Being on ≥3 antihypertensive agents * Chronic kidney disease * Diabetes mellitus or other systemic illness * Any history of substance abuse (other than tobacco) * Current cigarette smokers * History of gouty arthritis * Taking hormonal replacement therapy * Being obese (body mass index ≥30 kg/m2) * Endurance trained athletes * Impaired cognitive function or diagnosed dementia
Where this trial is running
Dallas, Texas
- Institute for Exercise and Environmental Medicine — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Qi Fu, MD, PhD — University of Texas Southwestern Medical Center
- Study coordinator: Qi Fu, MD, PhD
- Email: QiFu@texashealth.org
- Phone: 214-345-8125
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.