Inspiratory Muscle Training for Menopausal Hot Flashes

Overseen By Pamela Engrav

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Sleep aids

Disqualifiers: Spontaneous pneumothorax, Collapsed lung, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications as long as you have been on a consistent regimen for at least 3 months and continue it during the study. However, you cannot use sleep aids.

What data supports the effectiveness of this treatment for menopausal hot flashes?

Research shows that inspiratory muscle training (IMT) can improve respiratory muscle strength and endurance, exercise performance, and quality of life in older adults. While this is not directly related to menopausal hot flashes, these improvements suggest potential benefits for overall health and well-being, which might help manage symptoms. ^{1 2 3 4 5}

Is inspiratory muscle training safe for humans?

Resistance training, which includes inspiratory muscle training, is generally considered safe for postmenopausal women and can improve muscle strength and body composition. However, specific safety data for inspiratory muscle training targeting hot flashes is not detailed in the available research. ^{6 7 8 9 10}

How does inspiratory muscle training differ from other treatments for menopausal hot flashes?

Inspiratory muscle training is unique because it focuses on strengthening the muscles used for breathing, which is different from traditional treatments like hormone replacement therapy that target hormonal changes. This approach may offer a non-drug alternative for managing menopausal symptoms by potentially improving overall muscle performance and reducing hot flashes. ^{8 9 11 12 13}

What is the purpose of this trial?

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.

Research Team

Sarah Baker, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for midlife women experiencing menopausal hot flashes, with or without hypertension. Participants should be interested in trying a breathing exercise program using the POWERbreathe K3 device to potentially improve their symptoms.

Inclusion Criteria

Participants will be recruited from Rochester, MN and surrounding areas

Non-smokers

I am a woman aged 45-60 experiencing hot flashes.

Exclusion Criteria

I have been on stable hormone therapy or heart medication for over 3 months.

I use sleep aids like prescription drugs or supplements.

I don't have a history of lung collapse, unhealed perforated eardrum, or similar conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo inspiratory muscle strength training using the POWERbreathe K3 device

6 weeks

6 days a week

Follow-up

Participants are monitored for changes in blood pressure, MSNA, hot flash frequency, and sleep quality

4 weeks

Treatment Details

Interventions

• High-Resistance Inspiratory Muscle Strength Training
• Low-Resistance Inspiratory Muscle Strength Training

Trial Overview The study tests if strengthening the muscles used for breathing can help reduce hot flashes, affect nerve activity related to stress response, and improve sleep quality in menopausal women. It compares high-resistance against low-resistance training.

Participant Groups

Group I: High-Resistance Inspiratory Muscle Strength Training Group Experimental Treatment 2 Interventions

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.

Group II: Low-Resistance Inspiratory Muscle Strength Training Group Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

High-resistance inspiratory muscle strength training (IMST) significantly improved exercise tolerance in healthy adults aged 50-79, increasing treadmill exercise time by an average of 67 seconds after 6 weeks, while sham training showed no change.

IMST also led to positive changes in body composition, including a 4.8% reduction in trunk fat mass and a trend towards increased thorax lean mass, indicating potential benefits for physical health in midlife and older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Efficient, High-Resistance Inspiratory Muscle Strength Training Increases Exercise Tolerance in Midlife and Older Adults. Craighead, DH., Freeberg, KA., Heinbockel, TC., et al.[2023]

In a study of 26 older women (ages 60-69), 8 weeks of respiratory-muscle training led to significant improvements in respiratory muscle strength, with increases of 22% for inspiratory and 30% for expiratory strength compared to a control group.

The respiratory-muscle training group also showed enhanced exercise performance, including a 12% increase in treadmill performance time and reduced heart rate and perceived exertion during submaximal exercise, indicating that RM training can positively impact overall physical performance in older women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of respiratory-muscle training on exercise in older women. Watsford, M., Murphy, A.[2022]

Resistance training (RT) can significantly improve muscle mass, muscle strength, and functional fitness in women aged around 67 years, based on a review of 38 studies involving 2519 participants.

Incorporating dietary manipulation alongside resistance training may enhance these positive outcomes, suggesting that a combined approach could be particularly beneficial for peri- to postmenopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of resistance training on body composition, muscle strength, and functional fitness in older women (45-80 years): A systematic review (2010-2020). Ransdell, LB., Wayment, HA., Lopez, N., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Time-Efficient, High-Resistance Inspiratory Muscle Strength Training Increases Exercise Tolerance in Midlife and Older Adults. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The effects of respiratory-muscle training on exercise in older women. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training in older adults. [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of different respiratory muscle training regimes on fatigue-related variables during volitional hyperpnoea. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of high-intensity respiratory muscle training on respiratory muscle strength in individuals with Parkinson's disease: Protocol of a randomized clinical trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The impact of resistance training on body composition, muscle strength, and functional fitness in older women (45-80 years): A systematic review (2010-2020). [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The influence of resistance training on adipokines in post-menopausal women: A brief review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Muscular Strength Adaptations and Hormonal Responses After Two Different Multiple-Set Protocols of Resistance Training in Postmenopausal Women. [2019]

9. Canada pubmed.ncbi.nlm.nih.gov

Effect of whole-body resistance training at different load intensities on circulating inflammatory biomarkers, body fat, muscular strength, and physical performance in postmenopausal women. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of Ibuprofen and Resistance Training on Bone and Muscle: A Randomized Controlled Trial in Older Women. [2018]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Changes in Menopausal Risk Factors in Early Postmenopausal Osteopenic Women After 13 Months of High-Intensity Exercise: The Randomized Controlled ACTLIFE-RCT. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Muscle performance after the menopause. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Changes in muscle strength in women following the menopause: a longitudinal assessment of the efficacy of hormone replacement therapy. [2004]