Obesity (Disorder)NCT07787546
The Effectiveness of Respiratory Muscle Training and Exercise in Obese Adolescents
An observational study of Obesity (Disorder), run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of respiratory muscle training and exercise on respiratory muscle strength, pulmonary function, and exercise tolerance in obese adolescents diagnosed with specific learning disabilities. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Obesity (Disorder)
- What is being tested?
- Respiratory Muscle Training and Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Aug 2026to 21 Mar 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Special Education and Rehabilitation Center
Who may be able to join
- Age between 10 and 16 years.
- Body mass index (BMI) ≥ 95th percentile (or > +2 standard deviations/Z-score) according to World Health Organization (WHO) criteria.
- Diagnosis of specific learning disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), documented with a Child with Special Needs Report.
- Total intelligence quotient (IQ) score of ≥90 according to the Wechsler Intelligence Scale for Children (WISC-R).
- Written informed consent signed by the participants' legal guardians.
Who cannot join
- Presence of additional neurodevelopmental diagnoses such as cerebral palsy, epilepsy, pervasive developmental disorders, or intellectual disability.
- Uncontrolled cardiovascular diseases.
- Musculoskeletal disorders such as scoliosis, kyphosis, or chest wall deformities.
- Regular use of medications such as bronchodilators, steroids, or beta-blockers.
- History of an acute respiratory tract infection or surgical intervention within the previous 4 weeks.
- Presence of contraindications to spirometry according to the current guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Private Pendik Gokkusagi Special Education and Rehabilitation Center
Istanbul, Istanbul, 34916
About this study
Official title: Investigation of the Effectiveness of Respiratory Muscle Training and Exercise in Obese Adolescents With Specific Learning Disabilities
This study aims to investigate the effects of respiratory muscle training and exercise on respiratory muscle strength, pulmonary function, and exercise tolerance in obese adolescents diagnosed with specific learning disabilities. A total of 44 participants will be included and assigned to two different intervention groups, with 22 participants in each group. Participants will undergo baseline assessment, followed by assessments after routine treatment and after the intervention period. The study will compare changes in respiratory and functional outcomes between the two intervention groups.
- Conditions
- Obesity (Disorder)
- Being tested
- Respiratory Muscle Training, Exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Muscle TrainingBehavioural
- Respiratory Muscle Training - Intervention Description
Participants will receive respiratory muscle training using the POWERbreathe® Medic Classic device under the supervision of a physiotherapist for 12 weeks. The initial training load will be set at 40% of the participant's maximum inspiratory pressure (MIP). Training will be performed 3 days per week, with each session lasting 15 minutes and consisting of three sets of 10 breaths (30 breaths in total). The training resistance will be progressively adjusted according to each participant's individual condition.
ExerciseBehavioural
- Exercise Training - Intervention Description
Participants will receive an exercise program for 12 weeks, 3 days per week, with each session lasting 30 minutes. The program will consist of 5 minutes of warm-up, 10 minutes of moderate-intensity aerobic exercise, 10 minutes of resistance exercises, and 5 minutes of cool-down and relaxation exercises. Aerobic exercise intensity will initially be set at 40-59% of the estimated maximum heart rate and will gradually increase to 60-70%. Resistance exercises will include squats, lunges, planks, and rowing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Muscle Training Group | Not described Receives: Behavioral: Respiratory Muscle Training | |
| Exercise Group | Not described Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Inspiratory Pressure
Measured: Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
Secondary outcomes (5)
Emotional Eating Scale for Children and Adolescents
The scale consists of 26 items, with the item on happiness not included in the scoring. The scale is scored from a minimum of 25 to a maximum of 125 points; higher scores indicate increased eating behavior in response to negative emotional states. It is a valid and reliable measurement tool for assessing emotional eating in children and adolescents.
Measured: Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
Pulmonary Function Test
Measured: Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
Six-Minute Walk Test
Measured: Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
Physical Activity Questionnaire for Older Children
Except for the tenth question, which inquires about health status, each item in the survey is evaluated on a 5-point scale, resulting in an activity score between 1 and 5. "1" indicates low physical activity, while "5" indicates high physical activity.
Measured: Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
Pediatric Sleep Questionnaire
The Sleep-Related Respiratory Disorders Scale consists of 22 items, with scores ranging from 0.00 to 1.00. The scale score is calculated by ratioing the number of positive responses to the total number of valid responses; "I don't know" responses are excluded. Scores above 0.33 indicate a high risk of obstructive sleep apnea in children.
Measured: Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start31 Aug 2026
- Primary completion21 Mar 2027 (estimated)
- Study completion21 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- More trials run by Medipol 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Sarıyıldız, PhD(c), Medipol University
- Investigators
- Devrim Tarakcı, Prof., Principal investigator, İstanbul Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787546
- Sponsor's protocol ID
- E-10840098-50.04-5223
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Respiratory Muscle Training and Exercise in Obese Adolescents With Specific Learning Disabilities
- ClinicalTrials.gov ID
- NCT07787546
- Acronym / sponsor ID
- E-10840098-50.04-5223
- Conditions
- Obesity (Disorder)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 21 Mar 2027 (estimated)
- Study completion
- 21 Mar 2027 (estimated)
- First posted
- 26 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.
This study aims to investigate the effects of respiratory muscle training and exercise on respiratory muscle strength, pulmonary function, and exercise tolerance in obese adolescents diagnosed with specific learning disabilities. A total of 44 participants will be included and assigned to two different intervention groups, with 22 participants in each group. Participants will undergo baseline assessment, followed by assessments after routine treatment and after the intervention period. The study will compare changes in respiratory and functional outcomes between the two intervention groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory Muscle Training Group | – | Behavioral: Respiratory Muscle Training |
| Exercise Group | – | Behavioral: Exercise |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Special Education and Rehabilitation Center
Key inclusion criteria (5 listed)
- Age between 10 and 16 years.
- Body mass index (BMI) ≥ 95th percentile (or > +2 standard deviations/Z-score) according to World Health Organization (WHO) criteria.
- Diagnosis of specific learning disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), documented with a Child with Special Needs Report.
- Total intelligence quotient (IQ) score of ≥90 according to the Wechsler Intelligence Scale for Children (WISC-R).
- Written informed consent signed by the participants' legal guardians.
Key exclusion criteria (6 listed)
- Presence of additional neurodevelopmental diagnoses such as cerebral palsy, epilepsy, pervasive developmental disorders, or intellectual disability.
- Uncontrolled cardiovascular diseases.
- Musculoskeletal disorders such as scoliosis, kyphosis, or chest wall deformities.
- Regular use of medications such as bronchodilators, steroids, or beta-blockers.
- History of an acute respiratory tract infection or surgical intervention within the previous 4 weeks.
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 |
|---|---|---|
| Respiratory Muscle Training1. Respiratory Muscle Training - Intervention Description Participants will receive respiratory muscle training using the POWERbreathe® Medic Classic device under the supervision of a physiotherapist for 12 weeks. The initial training load will be set at 40% of the participant's maximum inspiratory pressure (MIP). Training will be performed 3 days per week, with each session lasting 15 minutes and consisting of three sets of 10 breaths (30 breaths in total). The training resistance will be progressively adjusted according to each participant's individual condition. | Behavioural | Respiratory Muscle Training Group |
| Exercise2. Exercise Training - Intervention Description Participants will receive an exercise program for 12 weeks, 3 days per week, with each session lasting 30 minutes. The program will consist of 5 minutes of warm-up, 10 minutes of moderate-intensity aerobic exercise, 10 minutes of resistance exercises, and 5 minutes of cool-down and relaxation exercises. Aerobic exercise intensity will initially be set at 40-59% of the estimated maximum heart rate and will gradually increase to 60-70%. Resistance exercises will include squats, lunges, planks, and rowing exercises. | Behavioural | Exercise Group |
Primary outcome
Maximum Inspiratory Pressure
Time frame: Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
5 secondary outcomes
Emotional Eating Scale for Children and Adolescents
Time frame: Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
Pulmonary Function Test
Time frame: Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
Six-Minute Walk Test
Time frame: Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
Physical Activity Questionnaire for Older Children
Time frame: Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
Pediatric Sleep Questionnaire
Time frame: Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
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 7 Oct 2026.
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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.
Devrim Tarakcı, Prof. principal investigator
İstanbul Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity (Disorder), run by Medipol 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 6 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: under way, not looking for participants, as of the sponsor's last update on 7 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. 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?
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?
Maximum Inspiratory Pressure (time frame: Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.). 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 7 Oct 2026.