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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG101515-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Resistance Inspiratory Muscle Strength Training Group | Experimental | Subjects 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. |
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| Low-Resistance Inspiratory Muscle Strength Training Group | Active Comparator | Subjects 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Resistance Inspiratory Muscle Strength Training | Behavioral | Performs inspiratory maneuvers at 55% maximal inspiratory pressure (PIMAX) during week 1, 65% PIMAX during week 2, and 75% PIMAX during weeks 3-6. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Measured in millimeters of mercury (mm Hg) | Baseline, 6 weeks |
| Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency | Measured by microneurography reported in burst per minute | Baseline, 6 weeks |
| Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence | Number of bursts recorded via microneurography | Baseline, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hot Flash Frequency | Number of hot flashes indicated through self-reporting | Baseline, 6 weeks |
| Chang in sleep duration | Measured by actigraphy data defined as recorded number of minutes in sleep |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pamela Engrav | Contact | (507) 255-6938 | engrav.pamela@mayo.edu | |
| Nancy Meyer | Contact | 507-255-0913 | meyer.nancy2@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Baker, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Low-Resistance Inspiratory Muscle Strength Training | Behavioral | Performs inspiratory maneuvers at 15% maximal inspiratory pressure (PIMAX) for all 6 weeks. |
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| POWERbreathe K3 device | Device | Inspiratory muscle training device |
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| Baseline, 6 weeks |
| Change in wake after sleep onset | Measured by actigraphy data defined as number of minutes from sleep onset to waking | Baseline, 6 weeks |
| Change in Pittsburgh Sleep Quality Index | 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. | Baseline, 6 weeks |
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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