Low Skeletal Muscle MasNCT07757139
High- and Moderate-Intensity Inspiratory Muscle Training on Diaphragm Ultrasound Parameters, Cognition, and Mental Health
A study testing High-Intensity IMT and Moderate-Intensity IMT in people with Low Skeletal Muscle Mas, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Low skeletal muscle mass during young adulthood may impair diaphragm function, cognition, sleep, and psychological well-being. Inspiratory muscle training (IMT) has been shown to improve respiratory muscle performance; however, it remains unclear whether different IMT intensities produce differential effects on… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Skeletal Muscle Mas
- What is being tested?
- High-Intensity IMT and Moderate-Intensity IMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to 23 Jun 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young adults aged 18 to 25 years.
- Low skeletal muscle mass defined as a skeletal muscle mass index (SMI) < 8.87 kg/m² for men and < 6.42 kg/m² for women.
- Clinically stable and able to safely participate in inspiratory muscle training.
- Willing and able to provide written informed consent.
- Able to comply with the study procedures and complete all assessments.
Who cannot join
- Presence of cardiovascular, neurological, orthopedic, psychiatric, respiratory, or other systemic diseases that could influence study outcomes.
- History of surgery that could affect participation or outcome assessments.
- Cognitive, psychological, or mental conditions that could interfere with participation or completion of the assessments.
- Inability or unwillingness to complete the intervention protocol or follow-up assessments.
- Any contraindication to inspiratory muscle training as determined by the investigators.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Munzur University Faculty of Health Sciences
Tunceli
About this study
Official title: Comparison of High- and Moderate-Intensity Inspiratory Muscle Training on Diaphragm Ultrasound Parameters, Cognition, and Mental Health in Young Adults With Low Muscle Mass Index: A Randomized Controlled Trial
Low skeletal muscle mass during young adulthood may impair diaphragm function, cognition, sleep, and psychological well-being. Inspiratory muscle training (IMT) has been shown to improve respiratory muscle performance; however, it remains unclear whether different IMT intensities produce differential effects on diaphragm morphology and function, cognition, sleep, anxiety, and health-related quality of life.
The purpose of this randomized controlled trial is to compare the effects of high-intensity inspiratory muscle training (HI-IMT), moderate-intensity inspiratory muscle training (MI-IMT), and sham inspiratory muscle training in young adults with low skeletal muscle mass.
Read more
A total of 69 participants with low skeletal muscle mass will be randomly assigned to one of three groups: (1) HI-IMT, (2) MI-IMT, or (3) sham IMT. Participants will complete a supervised 6-week intervention consisting of five training sessions per week.
Participants allocated to the HI-IMT group will perform inspiratory muscle training at approximately 80% of maximal inspiratory pressure (MIP), whereas those in the MI-IMT group will train at approximately 50-60% of MIP. The sham group will perform low-intensity inspiratory muscle training at approximately 15% of MIP. Training intensity will be adjusted throughout the intervention according to repeated MIP assessments.
Outcome assessments will be performed before and after the intervention. Primary outcomes will include diaphragm thickness, diaphragm thickening fraction, and diaphragm excursion assessed using ultrasonography. Secondary outcomes will include cognitive function assessed using the Montreal Cognitive Assessment (MoCA), sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI), daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS), insomnia severity assessed using the Insomnia Severity Index (ISI), anxiety assessed using the State-Trait Anxiety Inventory (STAI), and health-related quality of life assessed using the Short Form-36 Health Survey (SF-36).
The primary hypothesis is that both HI-IMT and MI-IMT will improve diaphragm morphology and function, cognition, sleep, anxiety, and health-related quality of life compared with sham IMT. It is further hypothesized that HI-IMT will produce greater improvements than MI-IMT because of the higher inspiratory training intensity.
Read the detailed description
Low skeletal muscle mass during young adulthood has become an increasingly recognized public health concern because it is associated with reduced physical performance, impaired metabolic health, and an increased risk of developing sarcopenia later in life. In addition to peripheral skeletal muscles, reduced muscle mass may affect diaphragm structure and function, potentially contributing to impaired respiratory mechanics as well as alterations in cognition, sleep, psychological well-being, and health-related quality of life. Although inspiratory muscle training (IMT) has been widely used to improve inspiratory muscle performance, the influence of different IMT intensities on diaphragm morphology and multidimensional health outcomes has not been fully established.
This randomized, sham-controlled clinical trial is designed to compare the effects of high-intensity inspiratory muscle training (HI-IMT), moderate-intensity inspiratory muscle training (MI-IMT), and sham inspiratory muscle training in young adults with low skeletal muscle mass. The primary objective is to determine whether training intensity influences changes in diaphragm structure and function assessed by ultrasonography. Secondary objectives are to evaluate the effects of different IMT intensities on cognitive function, sleep quality, daytime sleepiness, insomnia severity, anxiety, and health-related quality of life.
Participants aged 18-25 years with low skeletal muscle mass will be randomly assigned to one of three parallel groups using age- and sex-stratified block randomization. Participants allocated to the HI-IMT group will perform inspiratory muscle training at approximately 80% of maximal inspiratory pressure (MIP), whereas participants in the MI-IMT group will train at approximately 50-60% of MIP. Participants in the sham group will perform inspiratory muscle training using minimal resistance (approximately 15% of MIP). The intervention will last 6 weeks, with five training sessions per week. One session each week will be supervised by a physiotherapist, and the remaining sessions will be completed at home with regular monitoring.
Outcome assessments will be performed before and after the intervention. Primary outcome measures will include diaphragm thickness, diaphragm thickening fraction, and diaphragm excursion assessed using ultrasonography. Secondary outcome measures will include body composition, cognitive function assessed using the Montreal Cognitive Assessment (MoCA), sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI), daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS), insomnia severity assessed using the Insomnia Severity Index (ISI), anxiety assessed using the State-Trait Anxiety Inventory (STAI) and the Generalized Anxiety Disorder-7 (GAD-7), and health-related quality of life assessed using the Short Form-36 Health Survey (SF-36).
The study is designed to evaluate whether different inspiratory muscle training intensities are associated with differences in diaphragm morphology and function, cognitive function, sleep, anxiety, and health-related quality of life in young adults with low skeletal muscle mass.
- Conditions
- Low Skeletal Muscle Mas
- Being tested
- High-Intensity IMT, Moderate-Intensity IMT, Sham
- Keywords
- inspiratory muscle training, diaphragm ultrasonography, low skeletal muscle mass, cognitive function, anxiety, sleep quality
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity IMTOther
Participants performed a 6-week high-intensity inspiratory muscle training program using a threshold-loading inspiratory muscle trainer (POWERbreathe Classic Light Resistance). Training was conducted five days per week, consisting of one supervised session and four home-based sessions. The initial training intensity was set at approximately 80% of the predicted maximal inspiratory pressure (MIP) and was progressively adjusted weekly to maintain the target training intensity according to perceived exertion.
Moderate-Intensity IMTOther
Participants performed a 6-week moderate-intensity inspiratory muscle training program using a threshold-loading inspiratory muscle trainer (POWERbreathe Classic Light Resistance). Training was conducted five days per week, consisting of one supervised session and four home-based sessions. The initial training intensity was set at 50-60% of the predicted maximal inspiratory pressure (MIP) and was progressively adjusted weekly to maintain the prescribed training intensity.
ShamOther
Participants completed a 6-week sham inspiratory muscle training program using the same threshold-loading inspiratory muscle trainer. The intervention followed the same schedule as the active groups (five sessions per week, including one supervised and four home-based sessions), while the resistance was maintained at 15% of maximal inspiratory pressure throughout the study to provide minimal inspiratory loading without an intended training effect.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Inspiratory Muscle Training (HI-IMT) Group | Experimental | Participants assigned to this group completed a 6-week high-intensity inspiratory muscle training program using a POWERbreathe Classic Light Resistance device. Training was performed five days per week, including one supervised session and four home-based sessions. The initial training load was set at approximately 80% of the predicted maximal inspiratory pressure (MIP) and was progressively adjusted weekly to maintain the target training intensity. Receives: Other: High-Intensity IMT |
| Moderate-Intensity Inspiratory Muscle Training (MI-IMT) Group | Experimental | Participants assigned to this group completed a 6-week moderate-intensity inspiratory muscle training program using a POWERbreathe Classic Light Resistance device. Training was performed five days per week, including one supervised session and four home-based sessions. The initial training load was set at 50-60% of the predicted maximal inspiratory pressure (MIP) and was progressively adjusted weekly to maintain the prescribed training intensity. Receives: Other: Moderate-Intensity IMT |
| Sham Training Group | Sham comparator | Participants assigned to this group completed a 6-week sham inspiratory muscle training program using the same device and training schedule. The resistance was maintained at 15% of maximal inspiratory pressure (MIP) throughout the intervention to provide minimal inspiratory loading without an intended training effect. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diaphragm Thickness Measured by Ultrasonography
Diaphragm thickness will be assessed using B-mode ultrasonography at functional residual capacity (FRC) and total lung capacity (TLC). The primary outcome is the change in diaphragm thickness from baseline to completion of the 6-week intervention. Measurements will be performed by a blinded radiologist using a standardized ultrasound protocol.
Measured: Baseline and Week 6
Change in Diaphragm Thickening Fraction
Diaphragm thickening fraction measured by ultrasonography. The outcome is the change from baseline to Week 6.
Measured: Baseline and Week 6
Change in Diaphragm Excursion
Diaphragm excursion (mobility) measured by ultrasonography. The outcome is the change from baseline to Week 6.
Measured: Baseline and Week 6
Secondary outcomes (8)
Change in Montreal Cognitive Assessment (MoCA) Score
Cognitive function assessed using the Montreal Cognitive Assessment (MoCA). The Montreal Cognitive Assessment is a 30-point cognitive screening instrument with total scores ranging from 0 to 30. Higher scores indicate better cognitive function. The outcome measure is the change in total score from baseline to Week 6.
Measured: Baseline and Week 6
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index is a 21-point questionnaire with total scores ranging from 0 to 21. Higher scores indicate poorer sleep quality. The outcome measure is the change in total score from baseline to Week 6.
Measured: Baseline and Week 6
Change in Epworth Sleepiness Scale (ESS) Score
Daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS). The Epworth Sleepiness Scale is a 24-point questionnaire with total scores ranging from 0 to 24. Higher scores indicate greater daytime sleepiness. The outcome measure is the change in total score from baseline to Week 6.
Measured: Baseline and Week 6
Change in Insomnia Severity Index (ISI) Score
Insomnia severity assessed using the Insomnia Severity Index (ISI). The Insomnia Severity Index is a 28-point questionnaire with total scores ranging from 0 to 28. Higher scores indicate greater insomnia severity. The outcome measure is the change in total score from baseline to Week 6.
Measured: Baseline and Week 6
Change in State Anxiety Inventory (STAI-State) Score
State anxiety assessed using the State-Trait Anxiety Inventory-State (STAI-State). The State-Trait Anxiety Inventory-State is a 20-item questionnaire with total scores ranging from 20 to 80. Higher scores indicate greater state anxiety. The outcome measure is the change in total score from baseline to Week 6.
Measured: Baseline and Week 6
Change in Trait Anxiety Inventory (STAI-Trait) Score
Trait anxiety assessed using the State-Trait Anxiety Inventory-Trait (STAI-Trait). The State-Trait Anxiety Inventory-Trait is a 20-item questionnaire with total scores ranging from 20 to 80. Higher scores indicate greater trait anxiety. The outcome measure is the change in total score from baseline to Week 6.
Measured: Baseline and Week 6
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Generalized anxiety symptoms assessed using the Generalized Anxiety Disorder 7-item Scale (GAD-7). The Generalized Anxiety Disorder 7-item Scale is a 7-item questionnaire with total scores ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity. The outcome measure is the change in total score from baseline to Week 6.
Measured: Baseline and Week 6
Change in Short Form-36 (SF-36) Total Score
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). The 36-Item Short Form Health Survey generates a total score ranging from 0 to 100, with higher scores indicating better health-related quality of life. The outcome measure is the change in total score from baseline to Week 6.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start5 Jan 2026
- Primary completion21 May 2026
- Study completion23 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Skeletal Muscle MasStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyhun Topcuoglu, Munzur University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757139
- Sponsor's protocol ID
- 2025/16-2
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aktan R, Tertemiz KC, Yigit S, Ozalevli S, Ozgen Alpaydin A, Ucan ES. Effects of home-based telerehabilitation-assisted inspiratory muscle training in patients with idiopathic pulmonary fibrosis: A randomized controlled trial. Respirology. 2024 Dec;29(12):1077-1084. doi: 10.1111/resp.14810. Epub 2024 Aug 11.
PubMed 39129185
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High- and Moderate-Intensity Inspiratory Muscle Training on Diaphragm Ultrasound Parameters, Cognition, and Mental Health in Young Adults With Low Muscle Mass Index: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07757139
- Acronym / sponsor ID
- 2025/16-2
- Conditions
- Low Skeletal Muscle Mas
- Keywords
- inspiratory muscle training, diaphragm ultrasonography, low skeletal muscle mass, cognitive function, anxiety, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 23 Jun 2026 (actual)
- First posted
- 11 Aug 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.
Low skeletal muscle mass during young adulthood may impair diaphragm function, cognition, sleep, and psychological well-being. Inspiratory muscle training (IMT) has been shown to improve respiratory muscle performance; however, it remains unclear whether different IMT intensities produce differential effects on diaphragm morphology and function, cognition, sleep, anxiety, and health-related quality of life.
The purpose of this randomized controlled trial is to compare the effects of high-intensity inspiratory muscle training (HI-IMT), moderate-intensity inspiratory muscle training (MI-IMT), and sham inspiratory muscle training in young adults with low skeletal muscle mass.
A total of 69 participants with low skeletal muscle mass will be randomly assigned to one of three groups: (1) HI-IMT, (2) MI-IMT, or (3) sham IMT. Participants will complete a supervised 6-week intervention consisting of five training sessions per week.
Participants allocated to the HI-IMT group will perform inspiratory muscle training at approximately 80% of maximal inspiratory pressure (MIP), whereas those in the MI-IMT group will train at approximately 50-60% of MIP. The sham group will perform low-intensity inspiratory muscle training at approximately 15% of MIP. Training intensity will be adjusted throughout the intervention according to repeated MIP assessments.
Outcome assessments will be performed before and after the intervention. Primary outcomes will include diaphragm thickness, diaphragm thickening fraction, and diaphragm excursion assessed using ultrasonography. Secondary outcomes will include cognitive function assessed using the Montreal Cognitive Assessment (MoCA), sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI), daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS), insomnia severity assessed using the Insomnia Severity Index (ISI), anxiety assessed using the State-Trait Anxiety Inventory (STAI), and health-related quality of life assessed using the Short Form-36 Health Survey (SF-36).
The primary hypothesis is that both HI-IMT and MI-IMT will improve diaphragm morphology and function, cognition, sleep, anxiety, and health-related quality of life compared with sham IMT. It is further hypothesized that HI-IMT will produce greater improvements than MI-IMT because of the higher inspiratory training intensity.
Detailed description
Low skeletal muscle mass during young adulthood has become an increasingly recognized public health concern because it is associated with reduced physical performance, impaired metabolic health, and an increased risk of developing sarcopenia later in life. In addition to peripheral skeletal muscles, reduced muscle mass may affect diaphragm structure and function, potentially contributing to impaired respiratory mechanics as well as alterations in cognition, sleep, psychological well-being, and health-related quality of life. Although inspiratory muscle training (IMT) has been widely used to improve inspiratory muscle performance, the influence of different IMT intensities on diaphragm morphology and multidimensional health outcomes has not been fully established.
This randomized, sham-controlled clinical trial is designed to compare the effects of high-intensity inspiratory muscle training (HI-IMT), moderate-intensity inspiratory muscle training (MI-IMT), and sham inspiratory muscle training in young adults with low skeletal muscle mass. The primary objective is to determine whether training intensity influences changes in diaphragm structure and function assessed by ultrasonography. Secondary objectives are to evaluate the effects of different IMT intensities on cognitive function, sleep quality, daytime sleepiness, insomnia severity, anxiety, and health-related quality of life.
Participants aged 18-25 years with low skeletal muscle mass will be randomly assigned to one of three parallel groups using age- and sex-stratified block randomization. Participants allocated to the HI-IMT group will perform inspiratory muscle training at approximately 80% of maximal inspiratory pressure (MIP), whereas participants in the MI-IMT group will train at approximately 50-60% of MIP. Participants in the sham group will perform inspiratory muscle training using minimal resistance (approximately 15% of MIP). The intervention will last 6 weeks, with five training sessions per week. One session each week will be supervised by a physiotherapist, and the remaining sessions will be completed at home with regular monitoring.
Outcome assessments will be performed before and after the intervention. Primary outcome measures will include diaphragm thickness, diaphragm thickening fraction, and diaphragm excursion assessed using ultrasonography. Secondary outcome measures will include body composition, cognitive function assessed using the Montreal Cognitive Assessment (MoCA), sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI), daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS), insomnia severity assessed using the Insomnia Severity Index (ISI), anxiety assessed using the State-Trait Anxiety Inventory (STAI) and the Generalized Anxiety Disorder-7 (GAD-7), and health-related quality of life assessed using the Short Form-36 Health Survey (SF-36).
The study is designed to evaluate whether different inspiratory muscle training intensities are associated with differences in diaphragm morphology and function, cognitive function, sleep, anxiety, and health-related quality of life in young adults with low skeletal muscle mass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Inspiratory Muscle Training (HI-IMT) Group | Experimental | Other: High-Intensity IMTParticipants assigned to this group completed a 6-week high-intensity inspiratory muscle training program using a POWERbreathe Classic Light Resistance device. Training was performed five days per week, including one supervised session and four home-based sessions. The initial training load was set at approximately 80% of the predicted maximal inspiratory pressure (MIP) and was progressively adjusted weekly to maintain the target training intensity. |
| Moderate-Intensity Inspiratory Muscle Training (MI-IMT) Group | Experimental | Other: Moderate-Intensity IMTParticipants assigned to this group completed a 6-week moderate-intensity inspiratory muscle training program using a POWERbreathe Classic Light Resistance device. Training was performed five days per week, including one supervised session and four home-based sessions. The initial training load was set at 50-60% of the predicted maximal inspiratory pressure (MIP) and was progressively adjusted weekly to maintain the prescribed training intensity. |
| Sham Training Group | Sham comparator | Other: ShamParticipants assigned to this group completed a 6-week sham inspiratory muscle training program using the same device and training schedule. The resistance was maintained at 15% of maximal inspiratory pressure (MIP) throughout the intervention to provide minimal inspiratory loading without an intended training effect. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Young adults aged 18 to 25 years.
- Low skeletal muscle mass defined as a skeletal muscle mass index (SMI) < 8.87 kg/m² for men and < 6.42 kg/m² for women.
- Clinically stable and able to safely participate in inspiratory muscle training.
- Willing and able to provide written informed consent.
- Able to comply with the study procedures and complete all assessments.
Key exclusion criteria (5 listed)
- Presence of cardiovascular, neurological, orthopedic, psychiatric, respiratory, or other systemic diseases that could influence study outcomes.
- History of surgery that could affect participation or outcome assessments.
- Cognitive, psychological, or mental conditions that could interfere with participation or completion of the assessments.
- Inability or unwillingness to complete the intervention protocol or follow-up assessments.
- Any contraindication to inspiratory muscle training as determined by the investigators.
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 |
|---|---|---|
| High-Intensity IMTParticipants performed a 6-week high-intensity inspiratory muscle training program using a threshold-loading inspiratory muscle trainer (POWERbreathe Classic Light Resistance). Training was conducted five days per week, consisting of one supervised session and four home-based sessions. The initial training intensity was set at approximately 80% of the predicted maximal inspiratory pressure (MIP) and was progressively adjusted weekly to maintain the target training intensity according to perceived exertion. | Other | High-Intensity Inspiratory Muscle Training (HI-IMT) Group |
| Moderate-Intensity IMTParticipants performed a 6-week moderate-intensity inspiratory muscle training program using a threshold-loading inspiratory muscle trainer (POWERbreathe Classic Light Resistance). Training was conducted five days per week, consisting of one supervised session and four home-based sessions. The initial training intensity was set at 50-60% of the predicted maximal inspiratory pressure (MIP) and was progressively adjusted weekly to maintain the prescribed training intensity. | Other | Moderate-Intensity Inspiratory Muscle Training (MI-IMT) Group |
| ShamParticipants completed a 6-week sham inspiratory muscle training program using the same threshold-loading inspiratory muscle trainer. The intervention followed the same schedule as the active groups (five sessions per week, including one supervised and four home-based sessions), while the resistance was maintained at 15% of maximal inspiratory pressure throughout the study to provide minimal inspiratory loading without an intended training effect. | Other | Sham Training Group |
Primary outcome
Change in Diaphragm Thickness Measured by Ultrasonography
Time frame: Baseline and Week 6
Diaphragm thickness will be assessed using B-mode ultrasonography at functional residual capacity (FRC) and total lung capacity (TLC). The primary outcome is the change in diaphragm thickness from baseline to completion of the 6-week intervention. Measurements will be performed by a blinded radiologist using a standardized ultrasound protocol.
Change in Diaphragm Thickening Fraction
Time frame: Baseline and Week 6
Diaphragm thickening fraction measured by ultrasonography. The outcome is the change from baseline to Week 6.
Change in Diaphragm Excursion
Time frame: Baseline and Week 6
Diaphragm excursion (mobility) measured by ultrasonography. The outcome is the change from baseline to Week 6.
8 secondary outcomes
Change in Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline and Week 6
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline and Week 6
Change in Epworth Sleepiness Scale (ESS) Score
Time frame: Baseline and Week 6
Change in Insomnia Severity Index (ISI) Score
Time frame: Baseline and Week 6
Change in State Anxiety Inventory (STAI-State) Score
Time frame: Baseline and Week 6
Change in Trait Anxiety Inventory (STAI-Trait) Score
Time frame: Baseline and Week 6
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline and Week 6
Change in Short Form-36 (SF-36) Total Score
Time frame: Baseline and Week 6
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 11 Aug 2026.
- Background: PubMed 39129185Aktan R, Tertemiz KC, Yigit S, Ozalevli S, Ozgen Alpaydin A, Ucan ES. Effects of home-based telerehabilitation-assisted inspiratory muscle training in patients with idiopathic pulmonary fibrosis: A randomized controlled trial. Respirology. 2024 Dec;29(12):1077-1084. doi: 10.1111/resp.14810. Epub 2024 Aug 11.
- Individual participant dataSharing planned: No
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 High-Intensity IMT and Moderate-Intensity IMT in people with Low Skeletal Muscle Mas, run by Hacettepe University 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 5 inclusion and 5 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 11 Aug 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?
Change in Diaphragm Thickness Measured by Ultrasonography (time frame: Baseline and Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07757139, which also lists 1 linked publication.
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 11 Aug 2026.