Recruiting

Inspiratory Muscle Strength Training

Sponsor:

Mayo Clinic

Code:

NCT06743269

Conditions

Menopause

Hot Flashes

Blood Pressure Regulation

Eligibility Criteria

Sex: Female

Age: 45 - 60

Healthy Volunteers: Accepted

Interventions

High-Resistance Inspiratory Muscle Strength Training

Low-Resistance Inspiratory Muscle Strength Training

POWERbreathe K3 device

Study Details

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.

Conditions

Menopause

Hot Flashes

Blood Pressure Regulation

Study ID

NCT06743269

Start date

Mar 27, 2025

Status verified date

Jul, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 60

Healthy Volunteers: Accepted

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.).

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: High-Resistance Inspiratory Muscle Strength Training Group

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.

active comparator: Low-Resistance Inspiratory Muscle Strength Training Group

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.

Interventions

High-Resistance Inspiratory Muscle Strength Training

Performs 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

Performs inspiratory maneuvers at 15% maximal inspiratory pressure (PIMAX) for all 6 weeks.

POWERbreathe K3 device

Inspiratory muscle training device

Primary outcome measure

  • Change in blood pressure [ Time Frame: Baseline, 6 weeks ]
  • Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency [ Time Frame: Baseline, 6 weeks ]
  • Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence [ Time Frame: Baseline, 6 weeks ]

Central Contacts and Locations

Central contacts

Pamela Engrav

(507) 255-6938engrav.pamela@mayo.edu

Nancy Meyer

507-255-0913meyer.nancy2@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • menopause
  • blood pressure
  • inspiratory training
  • hot flashes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-09.