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The Effectiveness of Respiratory Muscle Training and Exercise in Obese Adolescents

Investigation of the Effectiveness of Respiratory Muscle Training and Exercise in Obese Adolescents With Specific Learning Disabilities

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07787546
Enrollment
44
Registered
2026-08-26
Start date
2026-09-01
Completion date
2027-03-31
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity (Disorder)

Brief 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. 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.

Interventions

BEHAVIORALRespiratory Muscle Training

1\. 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.

BEHAVIORALExercise

2\. 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.

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

\- 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).

Design outcomes

Primary

MeasureTime frame
Maximum Inspiratory PressureBaseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.

Secondary

MeasureTime frameDescription
Physical Activity Questionnaire for Older ChildrenBaseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.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.
Pulmonary Function TestBaseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
Six-Minute Walk TestBaseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.
Emotional Eating Scale for Children and AdolescentsBaseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.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.
Pediatric Sleep QuestionnaireBaseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.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.

Contacts

CONTACTDemet Sarıyıldız, MSc, PhD(c)
demet.sariyildiz@std.medipol.edu.tr+905066869182
PRINCIPAL_INVESTIGATORDevrim Tarakçı, Prof.

İstanbul Medipol University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026