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Active, not recruiting Observational

The Effectiveness of Respiratory Muscle Training and Exercise in Obese Adolescents

NCT07787546 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-08-31
Last updated
2026-10-07

Condition(s) studied

Obesity (Disorder)

Investigational drug(s) / intervention(s)

Respiratory Muscle TrainingExercise

Respiratory 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.

Exercise: 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.

Study 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.

Eligibility

Sex
ALL
Min age
10 Years
Max age
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).

Primary outcome measure(s)

  • Maximum Inspiratory Pressure — Baseline (T0), 3 months after routine treatment (T1), 3 months after the intervention (T2), until study completion, approximately 6 months.

Trial sites (1)

FacilityCityRegionStatus
Istanbul Private Pendik Gokkusagi Special Education and Rehabilitation Center Istanbul Istanbul
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07787546 on ClinicalTrials.gov ↗ ← All trials in Turkey