Inspiratory muscle training to lower blood pressure in postmenopausal women
Inspiratory Muscle Strength Training for Lowering Blood Pressure and Improving Endothelial Function in Postmenopausal Women: Comparison With "Standard of Care" Aerobic Exercise
This study is testing if a special breathing exercise can lower blood pressure more effectively than regular walking in postmenopausal women with high blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | University of Colorado, Boulder Academic / other |
| Locations | 1 site (Boulder, Colorado) |
| Trial ID | NCT05000515 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of high-resistance inspiratory muscle strength training (IMST) in reducing systolic blood pressure and improving vascular endothelial function in postmenopausal women with elevated blood pressure. Participants will be randomly assigned to either the IMST group or a standard aerobic exercise group, which involves brisk walking for 150 minutes per week. The study aims to confirm previous pilot findings that suggested IMST could lower blood pressure more significantly than aerobic exercise while also being a time-efficient intervention. The trial will measure changes in blood pressure and endothelial function over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women aged 50 and older with resting systolic blood pressure of 120 mmHg or greater.
Not a fit: Patients who are younger than 50 years, have uncontrolled hypertension, or have a history of significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel and effective method for managing high blood pressure and improving cardiovascular health in postmenopausal women.
How similar studies have performed: Previous pilot studies have shown promising results for inspiratory muscle strength training in this population, indicating potential for success in this larger trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postmenopausal women (\>12 months of amenorrhea) * Estrogen deficient (no hormone therapies within the previous 12 months) * Age 50 years and older * Ability to provide informed consent * Willing to accept random assignment to condition * Resting systolic blood pressure of 120 mmHg or greater * Body mass index \<40 kg/m2 * Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout study * No change in blood pressure medications or other medications (prescription or dosing) in the prior 3 months and willing to maintain current medication regimen * Free from clinical disease with the exception of hypertension Exclusion Criteria: * Younger than age 50 years * Early menopause (menopause before age 45 years) * Having had a hysterectomy * History of uncontrolled hypertension (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>120 mmHg) * Current smoker * Alcohol dependence or abuse * Abnormal blood pressure response to exercise (drop in systolic blood pressure below resting levels or systolic blood pressure \>260 mmHg or diastolic blood pressure \>115 mmHg) * Regular vigorous aerobic/endurance exercise (\>4 bouts/week, \>30 min/bout at a workload \>6 METS)
Where this trial is running
Boulder, Colorado
- Integrative Physiology of Aging Laboratory — Boulder, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Douglas R Seals, PhD — University of Colorado, Boulder
- Study coordinator: Daniel H Craighead, PhD
- Email: imststudy@colorado.edu
- Phone: 303-492-3010
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.