Inspiratory Muscle Training for Postmenopausal Women

(MRS Trial)

Overseen By Tyler H Blechschmid, M.S.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Beta blockers, Calcium blockers, Hormone therapy

Disqualifiers: Hypertension, Tobacco use, Heart condition, Asthma, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 33

Duration: 8 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how inspiratory muscle strength training affects heart health and mood in postmenopausal women. Participants will use a device called PrO2 Fit (IMT Trainer) to perform breathing exercises at either high resistance or a lower, simulated level. Women who have not had a menstrual cycle for at least six years, have a BMI between 25.0 and 39.9, and can walk without assistance might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance heart health and mood in postmenopausal women.

Will I have to stop taking my current medications?

Yes, if you are currently using prescription medications that affect heart rate or blood vessel dilation, you will need to stop taking them to participate in this trial.

What prior data suggests that the PrO2 Fit (IMT Trainer) is safe for postmenopausal women?

Research shows that using the PrO2 Fit device for inspiratory muscle training (IMT) is generally safe. Studies have found that after eight weeks of high-intensity IMT, participants, especially those with lung conditions like bronchiectasis, developed stronger muscles and better endurance. These studies reported no major side effects or problems.

The research indicates no major safety concerns, suggesting that the treatment is well-tolerated. Participants often felt more confident and less dependent on medical help after using the device. While some faced challenges like attending sessions and staying motivated, these issues did not relate to the treatment's safety.

Overall, evidence suggests that IMT with PrO2 Fit is safe, enhancing muscle strength and confidence, with no significant safety issues reported in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Inspiratory Muscle Training (IMT) for postmenopausal women because it offers a unique approach to strengthening respiratory muscles. Unlike traditional treatments that focus on medication or general exercise, IMT specifically targets the inspiratory muscles, potentially improving breathing efficiency and overall respiratory health. The PrO2 Fit device used in this training offers a personalized and progressive challenge, which can adapt to the user’s capacity, making it a highly tailored intervention. By incorporating adjustable resistance and a structured progression, IMT may provide more targeted benefits than existing options.

What evidence suggests that the PrO2 Fit (IMT Trainer) is effective for improving cardiovascular health and mood disturbance in postmenopausal women?

Research shows that inspiratory muscle training (IMT) strengthens breathing muscles and enhances their endurance during activity. One study found that using the PrO2 Fit IMT trainer for eight weeks improved the strength and endurance of breathing muscles in people with bronchiectasis, a lung condition. Another study found that high-intensity IMT increased diaphragm thickness and lung capacity. For older women, IMT has boosted breathing strength. This trial will compare the effects of IMT using the PrO2 Fit device with a Sham-IMT group. These findings suggest that IMT may improve breathing ability and overall health, which could be especially beneficial for postmenopausal women. ^{1 2 4 5 6}

Who Is on the Research Team?

Stephen J Carter, Ph.D

Principal Investigator

Indiana University, Bloomington

Are You a Good Fit for This Trial?

This trial is for postmenopausal women who are interested in how strengthening breathing muscles might improve heart health and mood. Details on specific inclusion or exclusion criteria were not provided, so it's best to contact the study team for more information.

Inclusion Criteria

Own or have access to a Bluetooth-capable phone or tablet (IOS version 12.0 or later or Android version 7.0 or later)

Body mass index between 25.0 to 39.9 kg/m2

I am a woman who has not had a menstrual cycle for at least 6 years.

Exclusion Criteria

Live or work > 80 miles from Bloomington, Indiana

Psychological or social characteristics that would interfere with their ability to fully participate in the study

I have not had surgery in my chest or abdomen in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo inspiratory muscle training (IMT) or sham IMT for 8 weeks, 4 times a week

8 weeks

32 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PrO2 Fit (IMT Trainer)

Trial Overview The trial is testing a device called PrO2 Fit, which is an Inspiratory Muscle Training (IMT) trainer. It aims to see if using this device can help with cardiovascular health and reduce mood disturbances in postmenopausal women.

How Is the Trial Designed?

Group I: Inspiratory Muscle Training (IMT) group Experimental Treatment 1 Intervention

The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 4 times a week, and over 8-weeks.

Group II: Sham Inspiratory Muscle Training (Sham-IMT) group Placebo Group 1 Intervention

Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 4 times a week, and over 8-weeks.

PrO2 Fit (IMT Trainer) is already approved in United States for the following indications:

Approved in United States as PrO2 Fit for:

• Rehabilitation for respiratory conditions
• Improvement of respiratory muscle strength and endurance

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

A new imaging method using high-resolution peripheral quantitative computed tomography (HR-pQCT) was developed to quantify intramuscular adipose tissue (IMAT) in skeletal muscle, which can help in the early detection of sarcopenia, a condition characterized by muscle loss and fat infiltration.

In both animal models and human subjects (ages 18 to 81), the study found strong correlations between IMAT levels, muscle density, and functional performance, indicating that this method can effectively assess muscle quality and predict the progression of myosteatosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HR-pQCT for the Evaluation of Muscle Quality and Intramuscular Fat Infiltration in Ageing Skeletal Muscle. Chow, SK., van Mourik, M., Hung, VW., et al.[2023]

In a study of 57 healthy older women aged 50-70, those who combined progressive resistance training (PRT) with protein supplementation showed significant improvements in upper leg lean tissue mass, knee extensor torque, and gait speed compared to those who only received protein supplementation.

The PRT + protein group increased upper leg lean tissue mass by 0.13 kg and improved knee extensor torque by 10.2 N m, demonstrating that this combined approach is effective for enhancing muscle quality and functional capability in older women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve weeks' progressive resistance training combined with protein supplementation beyond habitual intakes increases upper leg lean tissue mass, muscle strength and extended gait speed in healthy older women. Francis, P., Mc Cormack, W., Toomey, C., et al.[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]

Resistance training (RT) significantly improved muscle strength by 35.2% and muscle mass by 1.4% in postmenopausal women, while also reducing fat gain, particularly in the trunk area.

Soy isoflavone (ISO) supplementation did not have any significant effects on body composition or muscle strength, and there were no additional benefits when combined with resistance training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of resistance training and soy isoflavone on body composition in postmenopausal women. Orsatti, FL., Nahas, EA., Nahas-Neto, J., et al.[2022]

A 10-week sprint interval concurrent exercise training program significantly improved body composition and muscular strength in 65 inactive women aged 40-64, with reductions in fat mass and increases in lean body mass.

The program led to notable gains in lower-body strength (approximately 46.83 kg) and upper-body strength (approximately 11.68 kg), highlighting its potential to combat strength loss, which is a key factor in health risks for aging individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptations to a Concurrent Exercise Training Program in Inactive Aging Women. Wadsworth, DD., Rodriguez-Hernandez, M., Huffman, LS., et al.[2022]

In a study involving 42 pre-frail older women, the combination of inspiratory muscle training (IMT) and whole body vibration (WBV) significantly improved functional outcomes, such as walking distance and balance, compared to a sham group.

The IMT + WBV group showed greater improvements in the 6-minute walk test and timed up and go test, indicating enhanced physical performance and mobility, while handgrip strength and metabolic markers remained similar across groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in addition to whole body vibration for functional and physical outcomes in pre-frail older women: a randomized controlled trial. de Souza, HCM., Pessoa, MF., Dos Santos Clemente, R., et al.[2022]

Sarcopenia affects up to 50% of individuals over 80 years old, leading to significant risks such as functional disability and increased chances of falls and fractures, particularly in older women.

Resistance training is crucial for older adults to improve muscle quality, maintain bone density, and enhance overall quality of life, making it an essential component of healthy aging that clinicians should actively promote.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Training as Treatment for Sarcopenia: Examining Sex-Related Differences in Physiology and Response. Cheng, R., Maloney, A., Moran, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8001489/

The Effect of a High-Intensity PrO2Fit Inspiratory Muscle ... Eight weeks of IMT increased inspiratory muscle strength and endurance in those with bronchiectasis. IMT also had a positive effect on perceived competency and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03827356

"Inspiratory Muscle Training in Older Women" Objective: To evaluate the effectiveness of two protocols of inspiratory muscle training (IMT) in older women to improve respiratory strength, ...

3. pro2fit.com pro2fit.com/research

PrO2 - PrO2Health Research The findings of this study suggest that high-intensity IMT results in increased contracted diaphragm thickness and increased lung volumes and exercise ...

4. smartpatients.com smartpatients.com/trials/NCT06459674

Inspiratory Muscle Training in Postmenopausal Women This study is being conducted by the Department of Kinesiology within the School of Public Health at Indiana University Bloomington.

5. researchgate.net researchgate.net/publication/350117159_The_Effect_of_a_High-Intensity_PrO2Fit_Inspiratory_Muscle_Training_Intervention_on_Physiological_and_Psychological_Health_in_Adults_with_Bronchiectasis_A_Mixed-Methods_Study

The Effect of a High-Intensity PrO2Fit Inspiratory Muscle ... The results emphasize the importance of mental health and disease severity as significant determinants of life quality in patients, particularly female patients ...

6. nature.com nature.com/articles/s41394-022-00551-5

Adherence to and impact of home-based high-intensity IMT ... The secondary outcomes in this study were respiratory pressures and volumes and FSB [1, 2]. Inspiratory measures obtained through the PrO2 ...