Obesity & OverweightIMT and HIITNCT07810361
Combined Inspiratory Muscle Training and Functional High-Intensity Interval Training in Boys With Obesity
A study testing Inspiratory Muscle Training and Functional High-Intensity Interval Training in people with Obesity & Overweight and Childhood Obesity, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
Trial summary
Childhood obesity is associated with reduced cardiorespiratory fitness, impaired exercise tolerance, and altered respiratory mechanics. This randomized controlled trial investigated whether combining inspiratory muscle training with functional high-intensity interval training improves diaphragm morphology, respiratory… Read more about this study
- Who is it for?
- Ages 10 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Childhood Obesity
- What is being tested?
- Inspiratory Muscle Training and Functional High-Intensity Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Male sex.
- Age 10-12 years.
- Obesity according to World Health Organization age- and sex-specific BMI reference criteria.
- No regular participation in structured exercise training during the preceding six months.
- Medical clearance to participate in moderate-to-vigorous physical activity.
Who cannot join
- Diagnosed cardiovascular, neuromuscular, orthopaedic, or metabolic conditions that could interfere with exercise participation.
- Chronic respiratory disease, including asthma requiring regular medication.
- Impaired pulmonary function defined as FEV₁/FVC <75%.
- Upper respiratory tract infection within the preceding two weeks.
- Medication use that could affect respiratory function or exercise capacity.
- Previous thoracic surgery.
- Inability to complete the testing procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gumushane Üniversity
Trabzon, Gümüşhane Province, 29000
Coşkun Yılmaz, Associate professor, 05424427444, coskun.yilmaz@gumushane.edu.tr
About this study
Official title: Combined Inspiratory Muscle Training and Functional High-Intensity Interval Training Promote Respiratory, Diaphragmatic, and Aerobic Adaptations in Children With Obesity
Childhood obesity is associated with reduced cardiorespiratory fitness, impaired exercise tolerance, and altered respiratory mechanics. This randomized controlled trial investigated whether combining inspiratory muscle training with functional high-intensity interval training improves diaphragm morphology, respiratory muscle strength, pulmonary function, aerobic fitness, and functional exercise capacity in boys with obesity. Fifty boys aged 10-12 years were randomly assigned to six weeks of combined inspiratory muscle training and functional high-intensity interval training or usual activity.
Read the detailed description
This prospective, two-arm, randomized controlled trial investigated the effects of a six-week combined inspiratory muscle training and functional high-intensity interval training program in boys aged 10-12 years with obesity.
Fifty participants were randomly allocated in a 1:1 ratio to either a combined training group or a usual-activity control group. The intervention consisted of progressive inspiratory muscle training performed five days per week and functional high-intensity interval training performed three non-consecutive days per week for six weeks.
Inspiratory muscle training was performed using a threshold pressure-loading device. Training commenced at 30% of maximal inspiratory pressure and increased by 5% each week, reaching 55% of maximal inspiratory pressure in week 6. Each session consisted of two sets of 30 inspiratory efforts.
Functional high-intensity interval training was performed three times per week. Each approximately 35-40-minute session consisted of a standardized warm-up, a functional high-intensity interval circuit, and a cool-down. The circuit included wall sit, incline push-up, seated knee-to-chest exercise, shadow boxing, Superman exercise, and low-step-up exercise. Training intensity was progressively increased by manipulating work-to-rest ratios and circuit volume.
The control group continued habitual daily activities without participating in structured exercise or respiratory muscle training during the six-week study period.
Primary outcomes were diaphragm thickening fraction, inspiratory diaphragm thickness, and expiratory diaphragm thickness. Secondary outcomes included maximal inspiratory pressure, maximal expiratory pressure, forced vital capacity, forced expiratory volume in one second, FEV₁/FVC ratio, six-minute walk distance, estimated VO₂max, body composition, and perceived exertion.
Assessments were performed at baseline and after the six-week intervention under standardized laboratory conditions between 15:00 and 17:00. Diaphragm ultrasonography was performed by a radiologist blinded to group allocation
- Conditions
- Obesity & Overweight, Childhood Obesity
- Being tested
- Inspiratory Muscle Training, Functional High-Intensity Interval Training
- Keywords
- childhood obesity, inspiratory muscle training, high-intensity interval training, aerobic fitness, exercise-related metabolic health, functional exercise capacity, six-minute walk test, diaphragm thickness
- Medical subject headings
- Obesity, Overweight, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
Inspiratory muscle training was performed using a threshold pressure-loading device (POWERbreathe). Participants trained once daily, five days per week, for six consecutive weeks. Each session consisted of two sets of 30 inspiratory efforts. Training began at 30% of maximal inspiratory pressure in week 1, with the training load progressively increased by 5% each week to reach 55% of maximal inspiratory pressure in week 6. Training pressure was reassessed weekly, and all sessions were supervised by a certified exercise specialist.
Functional High-Intensity Interval TrainingOther
Functional high-intensity interval training was performed three times per week on non-consecutive days for six weeks. Each session lasted approximately 35-40 minutes and consisted of an approximately 8-minute warm-up, a functional high-intensity interval circuit, and an approximately 5-minute cool-down. The circuit included wall sit, incline push-up, seated knee-to-chest exercise, shadow boxing, Superman exercise, and low-step-up exercise. Training intensity was progressively increased by manipulating work-to-rest ratios and the number of circuit cycles. Perceived exertion was monitored using the Borg CR-10 scale.
| Study group | Role | What they receive |
|---|---|---|
| Combined IMT + Functional HIIT | Experimental | Participants received six weeks of combined inspiratory muscle training and functional high-intensity interval training in addition to their usual daily activities. Inspiratory muscle training was performed five days per week, and functional high-intensity interval training was performed three non-consecutive days per week. Receives: Other: Inspiratory Muscle Training; Other: Functional High-Intensity Interval Training |
| Usual Activity Control | No intervention | Participants continued their habitual daily activities throughout the six-week study period and did not participate in structured exercise or respiratory muscle training. They were instructed not to initiate a new exercise program until study completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Diaphragm Thickness
Inspiratory diaphragm thickness (DTins) was measured by ultrasound at the end of maximal inspiration at the zone of apposition of the right hemidiaphragm. Three measurements were obtained and averaged. The measurement represents an ultrasound-derived index of diaphragm morphology.
Measured: 6 weeks
Diaphragm Thickening Fraction
Diaphragm thickening fraction (DTf) was assessed using diaphragm ultrasonography and calculated as [(end-inspiratory diaphragm thickness - end-expiratory diaphragm thickness) / end-expiratory diaphragm thickness] × 100. Measurements were obtained from the right hemidiaphragm at the zone of apposition. Three measurements were obtained in each respiratory phase and averaged for analysis.
Measured: 6 weeks
Expiratory Diaphragm Thickness
Expiratory diaphragm thickness (DTexp) was measured by ultrasound at the end of maximal expiration at the zone of apposition of the right hemidiaphragm. Three measurements were obtained and averaged. The measurement represents an ultrasound-derived index of diaphragm morphology.
Measured: 6 week
Secondary outcomes (11)
Maximal Inspiratory Pressure
Maximal inspiratory pressure (MIP) was measured using a handheld mouth pressure meter according to ATS/ERS recommendations. Measurements were performed from residual volume, and the best reproducible values were recorded in cmH₂O.
Measured: 6 week
Maximal Expiratory Pressure
Maximal expiratory pressure (MEP) was measured using a handheld mouth pressure meter according to ATS/ERS recommendations. Measurements were performed from total lung capacity, and the best reproducible values were recorded in cmH₂O.
Measured: 6 week
Forced Vital Capacity
Forced vital capacity (FVC) was measured using spirometry according to ATS/ERS recommendations.
Measured: 6 week
Forced Expiratory Volume in One Second
Forced expiratory volume in one second (FEV₁) was measured using spirometry according to ATS/ERS recommendations.
Measured: 6 week
FEV₁/FVC Ratio
The FEV₁/FVC ratio was calculated from spirometric measurements obtained according to ATS/ERS recommendations.
Measured: 6 week
Six-Minute Walk Distance
Functional exercise capacity was assessed using the Six-Minute Walk Test. Participants walked for six minutes along a pre-measured, flat, straight corridor at a self-selected comfortable pace. The total distance covered in meters was recorded.
Measured: 6 week
Estimated VO2max
Estimated maximal oxygen uptake (VO₂max) was calculated from six-minute walk distance and body mass index using the validated prediction equation developed for children and adolescents with obesity: VO₂max = 26.9 + (0.014 × 6MWD [m]) - (0.38 × BMI [kg/m²]). VO₂max values were estimated and were not directly measured by cardiopulmonary exercise testing.
Measured: 6 week
Body Mass Index
Body composition was assessed using a multi-frequency bioelectrical impedance analyzer. Body mass index (BMI) and BMI z-score were assessed according to standardized procedures.
Measured: 6 week
Rating of Perceived Exertion
Perceived exercise intensity was assessed using the Borg Category Ratio-10 Rating of Perceived Exertion scale. Participants were familiarized with the scale before the intervention, and RPE was recorded immediately after each functional HIIT session throughout the six-week intervention period.
Measured: 6 week
Height
Body composition was assessed using a multi-frequency bioelectrical impedance analyzer. Height was assessed according to standardized procedures.
Measured: 6 Week
Weight
Body composition was assessed using a multi-frequency bioelectrical impedance analyzer. Weight was assessed according to standardized procedures.
Measured: 6 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start20 Oct 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly allocated in a 1:1 ratio to either a combined inspiratory muscle training and functional high-intensity interval training group or a usual-activity control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gümüşhane Universıty
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Coşkun YILMAZ, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810361
- Sponsor's protocol ID
- 2026/025
- Acronym
- IMT and HIIT
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared. The raw data supporting the conclusions of the study will be made available by the authors upon reasonable request, subject to applicable ethical, institutional, and data-protection requirements.
Publications
Kaeotawee P, Udomittipong K, Nimmannit A, Tovichien P, Palamit A, Charoensitisup P, Mahoran K. Effect of Threshold Inspiratory Muscle Training on Functional Fitness and Respiratory Muscle Strength Compared to Incentive Spirometry in Children and Adolescents With Obesity: A Randomized Controlled Trial. Front Pediatr. 2022 Jul 7;10:942076. doi: 10.3389/fped.2022.942076. eCollection 2022.
PubMed 35874588Deng Y, Wang X. Effect of high-intensity interval training on cardiorespiratory in children and adolescents with overweight or obesity: a meta-analysis of randomized controlled trials. Front Public Health. 2024 Jan 26;12:1269508. doi: 10.3389/fpubh.2024.1269508. eCollection 2024.
PubMed 38344230Caicedo-Trujillo S, Torres-Castro R, Vasconcello-Castillo L, Solis-Navarro L, Sanchez-Ramirez D, Nunez-Cortes R, Vera-Uribe R, Munoz-Munoz I, Barros-Poblete M, Romero JE, Vilaro J. Inspiratory muscle training in patients with obesity: a systematic review and meta-analysis. Front Med (Lausanne). 2023 Nov 27;10:1284689. doi: 10.3389/fmed.2023.1284689. eCollection 2023.
PubMed 38089877Vanhelst J, Fardy PS, Salleron J, Beghin L. The six-minute walk test in obese youth: reproducibility, validity, and prediction equation to assess aerobic power. Disabil Rehabil. 2013 Mar;35(6):479-82. doi: 10.3109/09638288.2012.699581. Epub 2012 Jul 10.
PubMed 22779759American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PubMed 12186831
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Inspiratory Muscle Training and Functional High-Intensity Interval Training Promote Respiratory, Diaphragmatic, and Aerobic Adaptations in Children With Obesity
- ClinicalTrials.gov ID
- NCT07810361
- Acronym / sponsor ID
- IMT and HIIT / 2026/025
- Conditions
- Obesity & Overweight, Childhood Obesity
- Keywords
- childhood obesity, inspiratory muscle training, high-intensity interval training, aerobic fitness, exercise-related metabolic health, functional exercise capacity, six-minute walk test, diaphragm thickness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gümüşhane UniversıtyUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 9 Sep 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.
Childhood obesity is associated with reduced cardiorespiratory fitness, impaired exercise tolerance, and altered respiratory mechanics. This randomized controlled trial investigated whether combining inspiratory muscle training with functional high-intensity interval training improves diaphragm morphology, respiratory muscle strength, pulmonary function, aerobic fitness, and functional exercise capacity in boys with obesity. Fifty boys aged 10-12 years were randomly assigned to six weeks of combined inspiratory muscle training and functional high-intensity interval training or usual activity.
Detailed description
This prospective, two-arm, randomized controlled trial investigated the effects of a six-week combined inspiratory muscle training and functional high-intensity interval training program in boys aged 10-12 years with obesity.
Fifty participants were randomly allocated in a 1:1 ratio to either a combined training group or a usual-activity control group. The intervention consisted of progressive inspiratory muscle training performed five days per week and functional high-intensity interval training performed three non-consecutive days per week for six weeks.
Inspiratory muscle training was performed using a threshold pressure-loading device. Training commenced at 30% of maximal inspiratory pressure and increased by 5% each week, reaching 55% of maximal inspiratory pressure in week 6. Each session consisted of two sets of 30 inspiratory efforts.
Functional high-intensity interval training was performed three times per week. Each approximately 35-40-minute session consisted of a standardized warm-up, a functional high-intensity interval circuit, and a cool-down. The circuit included wall sit, incline push-up, seated knee-to-chest exercise, shadow boxing, Superman exercise, and low-step-up exercise. Training intensity was progressively increased by manipulating work-to-rest ratios and circuit volume.
The control group continued habitual daily activities without participating in structured exercise or respiratory muscle training during the six-week study period.
Primary outcomes were diaphragm thickening fraction, inspiratory diaphragm thickness, and expiratory diaphragm thickness. Secondary outcomes included maximal inspiratory pressure, maximal expiratory pressure, forced vital capacity, forced expiratory volume in one second, FEV₁/FVC ratio, six-minute walk distance, estimated VO₂max, body composition, and perceived exertion.
Assessments were performed at baseline and after the six-week intervention under standardized laboratory conditions between 15:00 and 17:00. Diaphragm ultrasonography was performed by a radiologist blinded to group allocation
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly allocated in a 1:1 ratio to either a combined inspiratory muscle training and functional high-intensity interval training group or a usual-activity control group.
| Arm | Type | Receives |
|---|---|---|
| Combined IMT + Functional HIIT | Experimental | Other: Inspiratory Muscle Training, Other: Functional High-Intensity Interval TrainingParticipants received six weeks of combined inspiratory muscle training and functional high-intensity interval training in addition to their usual daily activities. Inspiratory muscle training was performed five days per week, and functional high-intensity interval training was performed three non-consecutive days per week. |
| Usual Activity Control | No intervention | –Participants continued their habitual daily activities throughout the six-week study period and did not participate in structured exercise or respiratory muscle training. They were instructed not to initiate a new exercise program until study completion. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male sex.
- Age 10-12 years.
- Obesity according to World Health Organization age- and sex-specific BMI reference criteria.
- No regular participation in structured exercise training during the preceding six months.
- Medical clearance to participate in moderate-to-vigorous physical activity.
Key exclusion criteria (7 listed)
- Diagnosed cardiovascular, neuromuscular, orthopaedic, or metabolic conditions that could interfere with exercise participation.
- Chronic respiratory disease, including asthma requiring regular medication.
- Impaired pulmonary function defined as FEV₁/FVC <75%.
- Upper respiratory tract infection within the preceding two weeks.
- Medication use that could affect respiratory function or exercise capacity.
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 TrainingInspiratory muscle training was performed using a threshold pressure-loading device (POWERbreathe). Participants trained once daily, five days per week, for six consecutive weeks. Each session consisted of two sets of 30 inspiratory efforts. Training began at 30% of maximal inspiratory pressure in week 1, with the training load progressively increased by 5% each week to reach 55% of maximal inspiratory pressure in week 6. Training pressure was reassessed weekly, and all sessions were supervised by a certified exercise specialist. | Other | Combined IMT + Functional HIIT |
| Functional High-Intensity Interval TrainingFunctional high-intensity interval training was performed three times per week on non-consecutive days for six weeks. Each session lasted approximately 35-40 minutes and consisted of an approximately 8-minute warm-up, a functional high-intensity interval circuit, and an approximately 5-minute cool-down. The circuit included wall sit, incline push-up, seated knee-to-chest exercise, shadow boxing, Superman exercise, and low-step-up exercise. Training intensity was progressively increased by manipulating work-to-rest ratios and the number of circuit cycles. Perceived exertion was monitored using the Borg CR-10 scale. | Other | Combined IMT + Functional HIIT |
Primary outcome
Inspiratory Diaphragm Thickness
Time frame: 6 weeks
Inspiratory diaphragm thickness (DTins) was measured by ultrasound at the end of maximal inspiration at the zone of apposition of the right hemidiaphragm. Three measurements were obtained and averaged. The measurement represents an ultrasound-derived index of diaphragm morphology.
Diaphragm Thickening Fraction
Time frame: 6 weeks
Diaphragm thickening fraction (DTf) was assessed using diaphragm ultrasonography and calculated as [(end-inspiratory diaphragm thickness - end-expiratory diaphragm thickness) / end-expiratory diaphragm thickness] × 100. Measurements were obtained from the right hemidiaphragm at the zone of apposition. Three measurements were obtained in each respiratory phase and averaged for analysis.
Expiratory Diaphragm Thickness
Time frame: 6 week
Expiratory diaphragm thickness (DTexp) was measured by ultrasound at the end of maximal expiration at the zone of apposition of the right hemidiaphragm. Three measurements were obtained and averaged. The measurement represents an ultrasound-derived index of diaphragm morphology.
11 secondary outcomes
Maximal Inspiratory Pressure
Time frame: 6 week
Maximal Expiratory Pressure
Time frame: 6 week
Forced Vital Capacity
Time frame: 6 week
Forced Expiratory Volume in One Second
Time frame: 6 week
FEV₁/FVC Ratio
Time frame: 6 week
Six-Minute Walk Distance
Time frame: 6 week
Estimated VO2max
Time frame: 6 week
Body Mass Index
Time frame: 6 week
Rating of Perceived Exertion
Time frame: 6 week
Height
Time frame: 6 Week
Weight
Time frame: 6 Week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 35874588Kaeotawee P, Udomittipong K, Nimmannit A, Tovichien P, Palamit A, Charoensitisup P, Mahoran K. Effect of Threshold Inspiratory Muscle Training on Functional Fitness and Respiratory Muscle Strength Compared to Incentive Spirometry in Children and Adolescents With Obesity: A Randomized Controlled Trial. Front Pediatr. 2022 Jul 7;10:942076. doi: 10.3389/fped.2022.942076. eCollection 2022.
- Background: PubMed 38344230Deng Y, Wang X. Effect of high-intensity interval training on cardiorespiratory in children and adolescents with overweight or obesity: a meta-analysis of randomized controlled trials. Front Public Health. 2024 Jan 26;12:1269508. doi: 10.3389/fpubh.2024.1269508. eCollection 2024.
- Background: PubMed 38089877Caicedo-Trujillo S, Torres-Castro R, Vasconcello-Castillo L, Solis-Navarro L, Sanchez-Ramirez D, Nunez-Cortes R, Vera-Uribe R, Munoz-Munoz I, Barros-Poblete M, Romero JE, Vilaro J. Inspiratory muscle training in patients with obesity: a systematic review and meta-analysis. Front Med (Lausanne). 2023 Nov 27;10:1284689. doi: 10.3389/fmed.2023.1284689. eCollection 2023.
- Background: PubMed 22779759Vanhelst J, Fardy PS, Salleron J, Beghin L. The six-minute walk test in obese youth: reproducibility, validity, and prediction equation to assess aerobic power. Disabil Rehabil. 2013 Mar;35(6):479-82. doi: 10.3109/09638288.2012.699581. Epub 2012 Jul 10.
- Background: PubMed 12186831American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared. The raw data supporting the conclusions of the study will be made available by the authors upon reasonable request, subject to applicable ethical, institutional, and data-protection requirements.
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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.
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 and Functional High-Intensity Interval Training in people with Obesity & Overweight and Childhood Obesity, run by Gümüşhane Universıty 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 7 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: opening soon, as of the sponsor's last update on 9 Sep 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Coşkun Yılmaz, Associate professor (+905424427444, coskun.yilmaz@gumushane.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory Diaphragm Thickness (time frame: 6 weeks). 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 NCT07810361, which also lists 5 linked publications.
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 9 Sep 2026.