Healthly VolunteersNCT07553039
Psychosocial and Cardiopulmonary Outcomes Following Diaphragm-Focused IMT Training in Healthy Women
A study testing Inspiratory Muscle Training(PowerBreathe) and Inspiratory Muscle Training (%0 MIP) in people with Healthly Volunteers and Women, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to determine whether diaphragm-focused IMT training has an effect on respiratory, psychosocial, and cardiovascular parameters in healthy women. The primary questions the study aims to address are as follows: Does Diaphragm-Focused Respiratory Muscle Training (IMT) positively affect… Read more about this study
- Who is it for?
- Ages 18 to 23 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthly Volunteers, Women
- What is being tested?
- Inspiratory Muscle Training(PowerBreathe) and Inspiratory Muscle Training (%0 MIP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 Jul 2026
- 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 18 to 23 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- She has been actively participating in sports for 5 years
- Between the ages of 18 and 23
Who cannot join
- A history of any cardiopulmonary disease and having any respiratory condition (such as COPD) or psychological disorder in daily life
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University, Faculty of Sport Sciences
Gaziantep
About this study
Official title: Effects of Inspiratory Muscle Training With Diaphragmatic Ac-tivation on Respiratory, Cardiovascular, and Psychosocial Pa-rameters in Female Athletes: A Randomized Controlled Trial
The aim of this clinical study is to determine whether diaphragm-focused IMT training has an effect on respiratory, psychosocial, and cardiovascular parameters in healthy women. The primary questions the study aims to address are as follows:
Does Diaphragm-Focused Respiratory Muscle Training (IMT) positively affect participants' psychosocial parameters (attention, anxiety, motivation)? Does Diaphragm-Focused Respiratory Muscle Training (IMT) improve participants' cardiovascular and respiratory parameters? To assess the effects of Diaphragm-Focused IMT on psychosocial, respiratory, and cardiovascular outcomes, participants were administered IMT at 0% of their MIP level, and the results were compared to a SHAM (placebo) group.
Read more
Participants:
They were divided into 3 groups (experimental, SHAM, control); The experimental and SHAM groups received one week of diaphragm muscle activation training before the experimental intervention began, followed by IMT administered five days a week for four weeks. The control group did not participate in any training and only took part in measurements.
All measurements were conducted in two phases-pre-test and post-test-under controlled laboratory conditions.
- Conditions
- Healthly Volunteers, Women
- Being tested
- Inspiratory Muscle Training(PowerBreathe), Inspiratory Muscle Training (%0 MIP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training(PowerBreathe)Device
IMT was performed five days a week for four weeks in the experimental groups. The experimental group performed resistance breathing exercises at 40% of their individual MIP values using the PowerBreathe (POWERBreathe International Ltd., Southam, UK) respiratory muscle training device. Each session was performed using a standard protocol (30 breaths × 2), consisting of 30 breaths, 1 min of rest, and another 30 breaths. MIP values were remeasured at the beginning of each week, and the training intensity was updated according to individual levels.
Inspiratory Muscle Training (%0 MIP)Device
IMT was performed five days a week for four weeks in sham groups. The experimental group performed resistance breathing exercises at 0% of their individual MIP values using the PowerBreathe (POWERBreathe International Ltd., Southam, UK) respiratory muscle training device. Each session was performed using a standard protocol (30 breaths × 2), consisting of 30 breaths, 1 min of rest, and another 30 breaths. Thus, the physiological effect was eliminated, and only procedural control was provided.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Device: Inspiratory Muscle Training(PowerBreathe) |
| SHAM | Sham comparator | Not described Receives: Device: Inspiratory Muscle Training (%0 MIP) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure (MIP)
Maximal Inspiratory Pressure (MIP) will be assessed as an index of inspiratory muscle strength using a calibrated respiratory pressure device in accordance with established guidelines. Measurements will be performed with participants in a seated position while wearing a nose clip. Participants will be instructed to perform maximal inspiratory efforts against an occluded airway starting from residual volume. At least two to three acceptable and reproducible maneuvers (variation ≤10%) will be obtained, and the highest value will be recorded for analysis. Metrics: Centimeters of water pressure (cmH₂O)
Measured: Baseline( 1 week) and immediately post-intervention( after 4 week)
Maximal Expiratory Pressure (MEP)
Maximal Expiratory Pressure (MEP) will be assessed as an index of expiratory muscle strength using the same calibrated respiratory pressure device under standardized conditions. Participants will perform maximal expiratory efforts against an occluded airway starting from total lung capacity. At least two to three acceptable and reproducible maneuvers (variation ≤10%) will be recorded, and the highest value will be used for analysis. Metrics: Centimeters of water pressure(cmH₂O)
Measured: Baseline (1 week) and immediately post-intervention( after 4 week)
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) will be measured using spirometry according to ATS standards under standardized resting conditions. The highest value from at least two acceptable maneuvers will be recorded. FVC represents the maximal volume of air exhaled forcefully after a full inspiration.
Metrics: Liters(L)
Measured: Baseline (1 week) and immediately post-intervention(after 4 week)
Forced Expiratory Volume in 1 Second (FEV₁)
Forced Expiratory Volume in 1 Second (FEV₁) will be assessed using spirometry in accordance with American Thoracic Society (ATS) standards. Measurements will be performed with participants in a seated position after reaching resting heart rate and oxygen saturation levels. Each participant will complete at least two acceptable maneuvers, and the highest value meeting ATS acceptability criteria will be recorded. FEV₁ reflects the volume of air exhaled during the first second of a forced expiratory maneuver.
Metrics: Liters (L)
Measured: Baseline (1 week) and immediately post-intervention (after 4 week)
Concentration Performance (CP) Score (d2 Attention Test)
Concentration Performance (CP) score will be assessed using the d2 Test of Attention as an index of selective attention and processing accuracy. The test consists of identifying and marking target stimuli under time pressure across multiple lines. CP is calculated as the total number of correctly marked target items minus commission errors (incorrectly marked items). The test will be administered under standardized conditions in a quiet environment, and scoring will follow established guidelines. Metrics: Score
Measured: Baseline (1 week) and immediately post-intervention( after 4 week)
State Anxiety Score (STAI Form I)
State anxiety will be assessed using the State-Trait Anxiety Inventory (STAI Form I), a validated self-report questionnaire designed to measure transient anxiety levels at a given moment. The instrument consists of 20 items rated on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating greater levels of state anxiety. The questionnaire will be administered under standardized conditions in a quiet environment, and scoring will be conducted standardized guidelines.
Metrics: Score (range: 20-80)
Measured: Baseline( 1 week) and immediately post-intervention( after 4 week)
Trait Anxiety Score (STAI Form II)
Trait anxiety will be assessed using the State-Trait Anxiety Inventory (STAI Form II), which evaluates relatively stable individual differences in anxiety proneness. The scale consists of 20 items rated on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating higher trait anxiety. The questionnaire will be administered and scored standardized procedures.
Metrics: Score ( range: 20-80)
Measured: Baseline (1 week) and immediately post-intervention (after 4 week)
Exercise Motivation Attitude Scale (Score)
Participants' motivation toward exercise is measured using the Exercise Motivation Attitude Scale. The scale consists of 20 items and uses a 7-point Likert-type rating scale. The total score ranges from 20 to 140, with higher scores indicating higher levels of motivation.
Metrics: Score (range: 20-140)
Measured: Baseline (1 week) and immediately post-intervention (after 4 week)
Heart Rate (HR)
Heart rate (HR) will be measured using a validated pulse oximeter under standardized resting conditions. Measurements will be obtained with participants in a seated position after reaching physiological rest. The average of two consecutive readings will be recorded. Heart rate reflects the number of cardiac beats per minute Metrics: Beats per minute (bpm)
Measured: Baseline (1 week) and immediately post-intervention (after 4 week)
Secondary outcomes (5)
Peak Expiratory Flow (PEF)
Peak Expiratory Flow (PEF) will be assessed via spirometry under standardized conditions. The highest value from acceptable maneuvers will be recorded. PEF represents the maximum flow achieved during a forced expiratory maneuver.
Metrics: Liters per second (L/s)
Measured: Baseline(1 week) and immediately post-intervention(after 4 week)
Forced Expiratory Flow 25-75% (FEF25-75%)
Forced Expiratory Flow at 25-75% of pulmonary volume (FEF25-75%) will be measured using spirometry ATS standards. The highest acceptable value will be used for analysis. This parameter reflects the average expiratory flow during the middle half of the forced vital capacity maneuver.
Metrics: Liters per second (L/s)
Measured: Baseline(1 week) and immediately post-intervention( after 4 week)
Total Number of Items Processed (TN) (d2 attention test)
The Total Number of Items Processed (TN) will be obtained from the d2 Test of Attention and represents the total number of stimuli scanned and processed by the participant within the test period. This parameter reflects processing speed and work pace under time constraints.
Metrics: Score
Measured: Baseline( 1 week) and immediately post- intervention (after 4 week)
Total Number of Items Processed Minus Errors (TN-E)
The Total Number of Items Processed Minus Errors (TN-E) will be calculated by subtracting omission and commission errors from the total number of processed items (TN). This parameter reflects overall task performance by integrating speed and accuracy.
Metrics: Score
Measured: Baseline (1 week) and immediately post-intervention (after 4 week)
Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (SpO₂) will be measured non-invasively using a calibrated pulse oximeter under standardized resting conditions. Participants will be seated and allowed to reach stable resting heart rate prior to measurement. SpO₂ values will be recorded after signal stabilization, and the average of two consecutive readings will be used for analysis. This parameter reflects the percentage of hemoglobin saturated with oxygen in arterial blood.
Metrics: Percentage (%)
Measured: Baseline (1 week) and immediately post-intervention ( after 4 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start15 May 2026
- Primary completion30 Jun 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthly VolunteersStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mete Berk Demiryol, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553039
- Sponsor's protocol ID
- 532274/17
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be made available to researchers who provide a methodologically sound proposal. Data will be available beginning 6 months and ending 36 months following publication. Requests should be directed to demiryolmete@gmail.com. To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training With Diaphragmatic Ac-tivation on Respiratory, Cardiovascular, and Psychosocial Pa-rameters in Female Athletes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07553039
- Acronym / sponsor ID
- 532274/17
- Conditions
- Healthly Volunteers, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 27 Apr 2026 (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.
The aim of this clinical study is to determine whether diaphragm-focused IMT training has an effect on respiratory, psychosocial, and cardiovascular parameters in healthy women. The primary questions the study aims to address are as follows:
Does Diaphragm-Focused Respiratory Muscle Training (IMT) positively affect participants' psychosocial parameters (attention, anxiety, motivation)? Does Diaphragm-Focused Respiratory Muscle Training (IMT) improve participants' cardiovascular and respiratory parameters? To assess the effects of Diaphragm-Focused IMT on psychosocial, respiratory, and cardiovascular outcomes, participants were administered IMT at 0% of their MIP level, and the results were compared to a SHAM (placebo) group.
Participants:
They were divided into 3 groups (experimental, SHAM, control); The experimental and SHAM groups received one week of diaphragm muscle activation training before the experimental intervention began, followed by IMT administered five days a week for four weeks. The control group did not participate in any training and only took part in measurements.
All measurements were conducted in two phases-pre-test and post-test-under controlled laboratory conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Inspiratory Muscle Training(PowerBreathe) |
| SHAM | Sham comparator | Device: Inspiratory Muscle Training (%0 MIP) |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- She has been actively participating in sports for 5 years
- Between the ages of 18 and 23
Key exclusion criteria (1 listed)
- A history of any cardiopulmonary disease and having any respiratory condition (such as COPD) or psychological disorder in daily life
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 |
|---|---|---|
| Inspiratory Muscle Training(PowerBreathe)IMT was performed five days a week for four weeks in the experimental groups. The experimental group performed resistance breathing exercises at 40% of their individual MIP values using the PowerBreathe (POWERBreathe International Ltd., Southam, UK) respiratory muscle training device. Each session was performed using a standard protocol (30 breaths × 2), consisting of 30 breaths, 1 min of rest, and another 30 breaths. MIP values were remeasured at the beginning of each week, and the training intensity was updated according to individual levels. | Device | Experimental |
| Inspiratory Muscle Training (%0 MIP)IMT was performed five days a week for four weeks in sham groups. The experimental group performed resistance breathing exercises at 0% of their individual MIP values using the PowerBreathe (POWERBreathe International Ltd., Southam, UK) respiratory muscle training device. Each session was performed using a standard protocol (30 breaths × 2), consisting of 30 breaths, 1 min of rest, and another 30 breaths. Thus, the physiological effect was eliminated, and only procedural control was provided. | Device | SHAM |
Primary outcome
Maximal Inspiratory Pressure (MIP)
Time frame: Baseline( 1 week) and immediately post-intervention( after 4 week)
Maximal Inspiratory Pressure (MIP) will be assessed as an index of inspiratory muscle strength using a calibrated respiratory pressure device in accordance with established guidelines. Measurements will be performed with participants in a seated position while wearing a nose clip. Participants will be instructed to perform maximal inspiratory efforts against an occluded airway starting from residual volume. At least two to three acceptable and reproducible maneuvers (variation ≤10%) will be obtained, and the highest value will be recorded for analysis. Metrics: Centimeters of water pressure (cmH₂O)
Maximal Expiratory Pressure (MEP)
Time frame: Baseline (1 week) and immediately post-intervention( after 4 week)
Maximal Expiratory Pressure (MEP) will be assessed as an index of expiratory muscle strength using the same calibrated respiratory pressure device under standardized conditions. Participants will perform maximal expiratory efforts against an occluded airway starting from total lung capacity. At least two to three acceptable and reproducible maneuvers (variation ≤10%) will be recorded, and the highest value will be used for analysis. Metrics: Centimeters of water pressure(cmH₂O)
Forced Vital Capacity (FVC)
Time frame: Baseline (1 week) and immediately post-intervention(after 4 week)
Forced Vital Capacity (FVC) will be measured using spirometry according to ATS standards under standardized resting conditions. The highest value from at least two acceptable maneuvers will be recorded. FVC represents the maximal volume of air exhaled forcefully after a full inspiration. Metrics: Liters(L)
Forced Expiratory Volume in 1 Second (FEV₁)
Time frame: Baseline (1 week) and immediately post-intervention (after 4 week)
Forced Expiratory Volume in 1 Second (FEV₁) will be assessed using spirometry in accordance with American Thoracic Society (ATS) standards. Measurements will be performed with participants in a seated position after reaching resting heart rate and oxygen saturation levels. Each participant will complete at least two acceptable maneuvers, and the highest value meeting ATS acceptability criteria will be recorded. FEV₁ reflects the volume of air exhaled during the first second of a forced expiratory maneuver. Metrics: Liters (L)
Concentration Performance (CP) Score (d2 Attention Test)
Time frame: Baseline (1 week) and immediately post-intervention( after 4 week)
Concentration Performance (CP) score will be assessed using the d2 Test of Attention as an index of selective attention and processing accuracy. The test consists of identifying and marking target stimuli under time pressure across multiple lines. CP is calculated as the total number of correctly marked target items minus commission errors (incorrectly marked items). The test will be administered under standardized conditions in a quiet environment, and scoring will follow established guidelines. Metrics: Score
State Anxiety Score (STAI Form I)
Time frame: Baseline( 1 week) and immediately post-intervention( after 4 week)
State anxiety will be assessed using the State-Trait Anxiety Inventory (STAI Form I), a validated self-report questionnaire designed to measure transient anxiety levels at a given moment. The instrument consists of 20 items rated on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating greater levels of state anxiety. The questionnaire will be administered under standardized conditions in a quiet environment, and scoring will be conducted standardized guidelines. Metrics: Score (range: 20-80)
Trait Anxiety Score (STAI Form II)
Time frame: Baseline (1 week) and immediately post-intervention (after 4 week)
Trait anxiety will be assessed using the State-Trait Anxiety Inventory (STAI Form II), which evaluates relatively stable individual differences in anxiety proneness. The scale consists of 20 items rated on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating higher trait anxiety. The questionnaire will be administered and scored standardized procedures. Metrics: Score ( range: 20-80)
Exercise Motivation Attitude Scale (Score)
Time frame: Baseline (1 week) and immediately post-intervention (after 4 week)
Participants' motivation toward exercise is measured using the Exercise Motivation Attitude Scale. The scale consists of 20 items and uses a 7-point Likert-type rating scale. The total score ranges from 20 to 140, with higher scores indicating higher levels of motivation. Metrics: Score (range: 20-140)
Heart Rate (HR)
Time frame: Baseline (1 week) and immediately post-intervention (after 4 week)
Heart rate (HR) will be measured using a validated pulse oximeter under standardized resting conditions. Measurements will be obtained with participants in a seated position after reaching physiological rest. The average of two consecutive readings will be recorded. Heart rate reflects the number of cardiac beats per minute Metrics: Beats per minute (bpm)
5 secondary outcomes
Peak Expiratory Flow (PEF)
Time frame: Baseline(1 week) and immediately post-intervention(after 4 week)
Forced Expiratory Flow 25-75% (FEF25-75%)
Time frame: Baseline(1 week) and immediately post-intervention( after 4 week)
Total Number of Items Processed (TN) (d2 attention test)
Time frame: Baseline( 1 week) and immediately post- intervention (after 4 week)
Total Number of Items Processed Minus Errors (TN-E)
Time frame: Baseline (1 week) and immediately post-intervention (after 4 week)
Oxygen Saturation (SpO₂)
Time frame: Baseline (1 week) and immediately post-intervention ( after 4 week)
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 26 Oct 2026.
- Individual participant dataSharing planned: Yes. The individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be made available to researchers who provide a methodologically sound proposal. Data will be available beginning 6 months and ending 36 months following publication. Requests should be directed to demiryolmete@gmail.com. To gain access, data requestors will need to sign a data access agreement.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training(PowerBreathe) and Inspiratory Muscle Training (%0 MIP) in people with Healthly Volunteers and Women, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 26 Oct 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 Turkey (Türkiye). 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?
Maximal Inspiratory Pressure (MIP) (time frame: Baseline( 1 week) and immediately post-intervention( after 4 week)). The study lists 9 primary outcomes in all. 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 26 Oct 2026.