Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women Using Inspiratory Muscle Strength Training

Mayo Clinic

Status: Enrolling

Conditions: Menopause; Blood Pressure Regulation; Hot Flashes

Treatments: Behavioral: High-Resistance Inspiratory Muscle Strength Training; Behavioral: Low-Resistance Inspiratory Muscle Strength Training; Device: POWERbreathe K3 device

Study type: Interventional

Funder types: Other

Identifiers

NCT06743269

23-011042

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 exclusion criteria will include the use of sleep aids (i.e., prescription, melatonin, doxylamine, valerian root, etc.).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

High-Resistance Inspiratory Muscle Strength Training Group

Experimental group

Description:

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.

Treatment:

Device: POWERbreathe K3 device

Behavioral: High-Resistance Inspiratory Muscle Strength Training

Low-Resistance Inspiratory Muscle Strength Training Group

Active Comparator group

Description:

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.

Treatment:

Device: POWERbreathe K3 device

Behavioral: Low-Resistance Inspiratory Muscle Strength Training