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Behavioural Intervention

Inspiratory Muscle Training for Postmenopausal Women (MRS Trial)

N/A
Recruiting
Led By Stephen J Carter, Ph.D
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to ambulate without assistance
Postmenopausal women (self-report at least 6 years since last menstrual cycle)
Must not have
Unable to provide informed consent
Anticipated elective surgery during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, within 48 hours of completing intervention
Awards & highlights

Summary

This trial aims to investigate how training to strengthen the muscles used for breathing can impact the heart health and mood of women who have gone through menopause.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects related to the use of the PrO2 Fit IMT trainer aren't detailed here. Generally, IMT may cause temporary muscle soreness or fatigue from training similar to other forms of exercise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk on my own without help.
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I am a woman who has not had a menstrual cycle for at least 6 years.
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I am between 50 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand or sign the consent form.
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I am planning to have surgery during the study.
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I am taking medication that affects my heart rate or blood vessels.
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I have been diagnosed with an aneurysm in my chest, abdomen, or brain.
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My blood pressure is not higher than 159/99 mm Hg.
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I have severe joint problems or reasons I can't do hard exercise.
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I have a history of heart conditions or heart attack.
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I have been diagnosed with asthma or chronic lung disease.
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I currently have a respiratory infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, within 48 hours of completing intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, within 48 hours of completing intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration
Secondary outcome measures
Distance Traveled
Other outcome measures
Cerebral Vascular Reactivity

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inspiratory Muscle Training (IMT) groupExperimental Treatment1 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) groupPlacebo Group1 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.

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Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,019 Previous Clinical Trials
1,114,191 Total Patients Enrolled
6 Trials studying Aging
3,431 Patients Enrolled for Aging
Stephen J Carter, Ph.DPrincipal InvestigatorIndiana University, Bloomington
~12 spots leftby Apr 2025
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