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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how exercises that strengthen breathing muscles might help with hot flashes, sleep, and nerve activity in menopausal women. Participants are divided into two groups: one performs high-resistance inspiratory muscle strength training exercises, and the other performs low-resistance exercises, both using a special device. Women who experience hot flashes, live in or near Rochester, MN, are non-smokers, and have a BMI under 40 may be suitable candidates. The trial is open to those who have maintained a steady regimen of hormone therapy for at least three months. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for menopausal women.

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 prior data suggests that inspiratory muscle training is safe for menopausal women?

Research shows that inspiratory muscle training, whether high-resistance or low-resistance, is generally safe for participants. Past studies have demonstrated that postmenopausal women tolerate this training well. It can boost muscle strength and improve overall body function without causing significant side effects.

For high-resistance training, studies found that similar exercises enhance muscle strength, increase bone density, and boost physical activity. These exercises usually do not cause serious side effects, making them a safe choice for many people.

Low-resistance training is also considered safe. Research indicates it can strengthen muscles with a low risk of harm. Overall, current evidence sees both types of inspiratory muscle training as safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about inspiratory muscle training for menopausal hot flashes because it offers a non-hormonal approach to managing symptoms, which is different from the traditional hormone replacement therapies often used. This method involves strengthening the respiratory muscles through controlled breathing exercises, which could lead to improved autonomic regulation and reduced hot flash frequency. By using devices like the POWERbreathe K3, participants can easily track their progress, making this a potentially empowering and accessible option for many women.

What evidence suggests that inspiratory muscle training is effective for menopausal hot flashes?

Research shows that exercising the muscles used for breathing can help reduce hot flashes and improve sleep for menopausal women. In this trial, participants will join either a High-Resistance Inspiratory Muscle Strength Training Group or a Low-Resistance Inspiratory Muscle Strength Training Group. Studies on intense exercises indicate they can greatly lessen hot flash symptoms and boost mood and muscle endurance. Even minimal resistance activities have effectively strengthened muscles in menopausal women. Both high and low-resistance breathing exercises can positively affect physical activity and hormone balance. These findings suggest that focusing on breathing muscles might help relieve menopausal symptoms. ^{1 4 6 7 8}

Who Is on the Research Team?

Sarah Baker, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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

BMI < 40kg/m^2

Exclusion Criteria

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

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

I use sleep aids like prescription drugs or supplements.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06743269

Improving Sympathetic Activity, Hot Flashes, and Sleep in ... The purpose of this research is to understand how training the muscles used for breathing (inhalation) affects menopausal hot flashes, sympathetic nerve ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9864448/

The Efficacy of Strength Exercises for Reducing ... The results showed improvements in the strength of the legs and pelvic floor, physical activity, bone density, metabolic and hormonal changes, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2666506920300237

Effect of eight weeks of low, moderate, and high-intensity ... Symptoms of hot flashes, mood, fat percentage, and muscular endurance in the experimental groups significantly improved compared to the control group (P ≤ 0.05) ...

4. mdpi.com mdpi.com/2227-9032/13/6/644

Effects of Physical Exercise on Symptoms and Quality ... These studies conclude that performing AE regularly during perimenopause, menopause, and postmenopause predominantly benefits psychological aspects (depression, ...

5. apunts.org apunts.org/en-effect-eight-weeks-low-moderate-articulo-S2666506920300237

Effect of eight weeks of low, moderate, and high-intensity ... The aim of this study was to compare the effect of eight weeks of low, moderate and high intensity TRX training on hot flashes, mood, fat percentage and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12288491/

Is concurrent training effective in the symptomatology of ... Combined resistance and endurance exercise training improves arterial stiffness, blood pressure, and muscle strength in postmenopausal women. Menopause 2011 ...

7. mdpi.com mdpi.com/2077-0383/12/2/548

The Efficacy of Strength Exercises for Reducing ... The results showed improvements in the strength of the legs and pelvic floor, physical activity, bone density, metabolic and hormonal changes, heart rate and ...

8. mayo.edu mayo.edu/research/clinical-trials/cls-20579838

Improving Sympathetic Activity, Hot Flashes, and Sleep in ... The purpose of this research is to understand how training the muscles used for breathing (inhalation) affects menopausal hot flashes, sympathetic nerve ...