Postmenopausal SymptomsMRSNCT06459674
Inspiratory Muscle Training in Postmenopausal Women
A study testing PrO2 Fit (IMT Trainer) in people with Postmenopausal Symptoms and Aging, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Symptoms, Aging, Obesity
- What is being tested?
- PrO2 Fit (IMT Trainer)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women (self-report at least 6 years since last menstrual cycle)
- Aged 50-75 years (confirmed by birth date listed on participant's driver license at screening visit)
- English-speaking
- Body mass index between 25.0 to 39.9 kg/m2
- Able to ambulate without assistance
- Own or have access to a Bluetooth-capable phone or tablet (IOS version 12.0 or later or Android version 7.0 or later)
Who cannot join
- Unable to provide informed consent.
- Greater than stage II hypertension (i.e., >159/99 mm Hg)
- Current tobacco use (self-report)
- Habitually exercise training ≥ 2 days per week (self-report)
- Significant orthopedic limitations or other contraindications to strenuous exercise
- Live or work > 80 miles from Bloomington, Indiana
Show all 15Show fewer
- Anticipated elective surgery during the study period.
- Surgery to the chest or abdomen in the last 6 months.
- Plan to move residence or travel out of the local area during the study period.
- History of heart attack or heart condition.
- Current use of prescription medications that affect heart rate or blood vessel dilation (e.g., systemic b-adrenergic blockers, calcium channel blockers, and hormone replacement therapy).
- Diagnosis of asthma or chronic pulmonary disease.
- Current respiratory infection.
- Diagnosis of an aneurysm in the chest, abdomen, or brain.
- Psychological or social characteristics that would interfere with their ability to fully participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mean ReSponse Time: Effects of Inspiratory Muscle Training in Postmenopausal Women (MRS)
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.
Read the detailed description
Inspiratory muscle training (IMT) works by strengthening the respiratory muscles through resistive airflow breathing using a handheld device. The goal being to elicit an adaptive response akin to resistance exercise for locomotor muscles. Labored breathing due to respiratory muscle weakness can detract from physical performance with attendant consequences on independent living. This may trigger a maladaptive cycle that worsens physiological and psychosocial outcomes. IMT from 6-10 weeks has been shown to increase maximal inspiratory pressure, functional capacity, and perceived breathlessness across disease states. To inform an appropriately powered randomized controlled trial, the present work proposes a 2-arm single-blind, randomized pilot study to evaluate outcomes of interest.
- Conditions
- Postmenopausal Symptoms, Aging, Obesity
- Being tested
- PrO2 Fit (IMT Trainer)
- Keywords
- postmenopausal, aging, women's health, blood pressure, mean response time, Inspiratory Muscle Training (IMT)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrO2 Fit (IMT Trainer)Device
The device is used four times a week over a period of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training (IMT) group | Experimental | 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. Receives: Device: PrO2 Fit (IMT Trainer) |
| Sham Inspiratory Muscle Training (Sham-IMT) group | Sham comparator | 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. Receives: Device: PrO2 Fit (IMT Trainer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration
Duration, reported in seconds, to reach 63% of steady-state V̇O2 during a fixed-workload treadmill task. This technique is performed using breath-by-breath open-circuit spirometry and captures the V̇O2 fast component occurring in the transition from standing rest to treadmill walking.
Measured: Baseline, within 48 hours of completing intervention
Secondary outcomes (1)
Distance Traveled
Distance traveled, reported in meters, during a 6-minute walk test. The assessment offers reliable and valid insight concerning exercise capacity in older women.
Measured: Baseline, within 9 days of completing intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start12 Apr 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal SymptomsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen J. Carter, Ph.D., Indiana University
- Investigators
- Stephen J Carter, Ph.D, Principal investigator, Indiana University, Bloomington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459674
- Sponsor's protocol ID
- 20387
- Acronym
- MRS
- Status last verified
- Feb 2026
- First submitted
- 21 May 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IDP sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mean ReSponse Time: Effects of Inspiratory Muscle Training in Postmenopausal Women (MRS)
- ClinicalTrials.gov ID
- NCT06459674
- Acronym / sponsor ID
- MRS / 20387
- Conditions
- Postmenopausal Symptoms, Aging, Obesity
- Keywords
- postmenopausal, aging, women's health, blood pressure, mean response time, Inspiratory Muscle Training (IMT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inspiratory muscle training (IMT) works by strengthening the respiratory muscles through resistive airflow breathing using a handheld device. The goal being to elicit an adaptive response akin to resistance exercise for locomotor muscles. Labored breathing due to respiratory muscle weakness can detract from physical performance with attendant consequences on independent living. This may trigger a maladaptive cycle that worsens physiological and psychosocial outcomes. IMT from 6-10 weeks has been shown to increase maximal inspiratory pressure, functional capacity, and perceived breathlessness across disease states. To inform an appropriately powered randomized controlled trial, the present work proposes a 2-arm single-blind, randomized pilot study to evaluate outcomes of interest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training (IMT) group | Experimental | Device: PrO2 Fit (IMT Trainer)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. |
| Sham Inspiratory Muscle Training (Sham-IMT) group | Sham comparator | Device: PrO2 Fit (IMT Trainer)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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal women (self-report at least 6 years since last menstrual cycle)
- Aged 50-75 years (confirmed by birth date listed on participant's driver license at screening visit)
- English-speaking
- Body mass index between 25.0 to 39.9 kg/m2
- Able to ambulate without assistance
Key exclusion criteria (15 listed)
- Unable to provide informed consent.
- Greater than stage II hypertension (i.e., >159/99 mm Hg)
- Current tobacco use (self-report)
- Habitually exercise training ≥ 2 days per week (self-report)
- Significant orthopedic limitations or other contraindications to strenuous exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrO2 Fit (IMT Trainer)The device is used four times a week over a period of 8 weeks. | Device | Inspiratory Muscle Training (IMT) group, Sham Inspiratory Muscle Training (Sham-IMT) group |
Primary outcome
Duration
Time frame: Baseline, within 48 hours of completing intervention
Duration, reported in seconds, to reach 63% of steady-state V̇O2 during a fixed-workload treadmill task. This technique is performed using breath-by-breath open-circuit spirometry and captures the V̇O2 fast component occurring in the transition from standing rest to treadmill walking.
1 secondary outcome
Distance Traveled
Time frame: Baseline, within 9 days of completing intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No. No IDP sharing plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Carter, Ph.D principal investigator
Indiana University, Bloomington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrO2 Fit (IMT Trainer) in people with Postmenopausal Symptoms and Aging, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration (time frame: Baseline, within 48 hours of completing intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.