Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women Using Inspiratory Muscle Strength Training
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- Mayo Clinic
- Study ID
- NCT06743269
- Status
- Recruiting
Conditions
- Blood Pressure Regulation
- Hot Flashes
- Menopause
Eligibility Criteria
- Sex
- FEMALE
- Age
- 45 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- High-Resistance Inspiratory Muscle Strength Training — BEHAVIORALPerforms inspiratory maneuvers at 55% maximal inspiratory pressure (PIMAX) during week 1, 65% PIMAX during week 2, and 75% PIMAX during weeks 3-6.
- Low-Resistance Inspiratory Muscle Strength Training — BEHAVIORALPerforms inspiratory maneuvers at 15% maximal inspiratory pressure (PIMAX) for all 6 weeks.
- POWERbreathe K3 device — DEVICEInspiratory muscle training device
Study Details
The purpose of this research is to understand how training the muscles used for breathing (inhalation) affects menopausal hot flashes, sympathetic nerve activity and sleep.
Key Dates
- Start date
- Mar 27, 2025
- Status verified
- Mar 2026
- Primary completion
- Jan 1, 2027
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: High-Resistance Inspiratory Muscle Strength Training GroupSubjects will partake in 5 sets of 6 inspiratory maneuvers (total: 30 maneuvers/session) 6 days a week for 6 weeks using the POWERbreathe K3 device to monitor adherence.
- Active Comparator: Low-Resistance Inspiratory Muscle Strength Training GroupSubjects will partake in 5 sets of 6 inspiratory maneuvers (total: 30 maneuvers/session) 6 days a week for 6 weeks using the POWERbreathe K3 device to monitor adherence.
Primary Outcome Measure
Change in blood pressure [ Time Frame: Baseline, 6 weeks ]
Central Contacts
- Pamela Engrav(507) 255-6938
- Nancy Meyer507-255-0913
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | - |
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