Blood Pressure Regulation, Hot Flashes, Menopause
Conditions
Keywords
menopause, blood pressure, inspiratory training, hot flashes
Brief summary
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.
Interventions
Performs inspiratory maneuvers at 55% maximal inspiratory pressure (PIMAX) during week 1, 65% PIMAX during week 2, and 75% PIMAX during weeks 3-6.
BEHAVIORALLow-Resistance Inspiratory Muscle Strength Training
Performs inspiratory maneuvers at 15% maximal inspiratory pressure (PIMAX) for all 6 weeks.
DEVICEPOWERbreathe K3 device
Inspiratory muscle training device
Sponsors
Mayo Clinic
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Females aged 45-60 with hot flashes. * Participants will be recruited from Rochester, MN and surrounding areas. * Non-smokers. * BMI \< 40kg/m\^2. * No history of cardiovascular disease, except for hypertension.
Exclusion criteria
* Detailed medical and social histories will be collected. To allow for ecological validity, participants will not be excluded for use of menopausal hormone therapy or medications affecting cardiovascular function so long as they have been on a consistent regimen for ≥3 months and during the study period. This approach to medications is consistent with recent work in this area. * Participants will be screened for contraindications to inspiratory muscle strength training including, a history of spontaneous pneumothorax, collapsed lung that has not healed fully, a perforated eardrum that has not healed fully, and/or any other condition of the eardrum. * Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure | Baseline, 6 weeks | Measured in millimeters of mercury (mm Hg) |
| Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency | Baseline, 6 weeks | Measured by microneurography reported in burst per minute |
| Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence | Baseline, 6 weeks | Number of bursts recorded via microneurography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hot Flash Frequency | Baseline, 6 weeks | Number of hot flashes indicated through self-reporting |
| Chang in sleep duration | Baseline, 6 weeks | Measured by actigraphy data defined as recorded number of minutes in sleep |
| Change in wake after sleep onset | Baseline, 6 weeks | Measured by actigraphy data defined as number of minutes from sleep onset to waking |
| Change in Pittsburgh Sleep Quality Index | Baseline, 6 weeks | The Pittsburgh Sleep Quality Index measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance. |
Countries
United States
Contacts
CONTACTPamela Engrav
CONTACTNancy Meyer
PRINCIPAL_INVESTIGATORSarah Baker, PhD
Mayo Clinic
Outcome results
None listed