Inspiratory Muscle Training for Postmenopausal Women

(MRS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Stephen J Carter, Ph.D

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

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

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This study is being conducted by the Department of Kinesiology within the School of Public Health at Indiana University Bloomington. The purpose of this study is to better understand how inspiratory muscle strength training affects cardiovascular health and mood disturbance 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 data supports the effectiveness of the treatment PrO2 Fit (IMT Trainer) for postmenopausal women?

Inspiratory muscle training (IMT) has been shown to improve functional outcomes and physical performance in older women, suggesting it could be beneficial for postmenopausal women as well. ^{1 2 3 4 5}

How does the PrO2 Fit (IMT Trainer) treatment differ from other treatments for postmenopausal women?

The PrO2 Fit (IMT Trainer) is unique because it focuses on strengthening the inspiratory muscles (muscles used for breathing in), which is different from traditional resistance training that targets overall muscle strength and body composition. This device offers a novel approach by specifically enhancing respiratory muscle function, which can improve breathing efficiency and potentially benefit overall physical performance in postmenopausal women. ^{1 2 4 6 7}

Research Team

Stephen J Carter, Ph.D

Principal Investigator

Indiana University, Bloomington

Eligibility Criteria

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)

I speak English.

Body mass index between 25.0 to 39.9 kg/m2

Exclusion Criteria

Live or work > 80 miles from Bloomington, Indiana

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

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

Trial Timeline

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)

Treatment Details

Interventions

• PrO2 Fit (IMT Trainer) (Behavioural Intervention)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Indiana University Bloomington, IN

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1063

Patients Recruited

1,182,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. 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]

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

Effects of resistance training and soy isoflavone on body composition in postmenopausal women. [2022]

3. England 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. [2022]

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

Resistance Training as Treatment for Sarcopenia: Examining Sex-Related Differences in Physiology and Response. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

HR-pQCT for the Evaluation of Muscle Quality and Intramuscular Fat Infiltration in Ageing Skeletal Muscle. [2023]

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

Adaptations to a Concurrent Exercise Training Program in Inactive Aging Women. [2022]

7. Netherlands 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. [2022]