The Effectiveness of Respiratory Muscle Training and Exercise in Obese Adolescents

NCT07787546 | Not Yet Recruiting

• 1 other identifier: E-10840098-50.04-5223
• Study Type: observational
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity (Disorder)

Outcome Measures

Primary Outcomes (1)

• Maximum Inspiratory Pressure

  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

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

• Pulmonary Function Test

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

• Six-Minute Walk Test

  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

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

• Pediatric Sleep Questionnaire

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

Study Arms (2)

Respiratory Muscle Training Group

Behavioral: Respiratory Muscle Training

Exercise Group

Behavioral: Exercise

Interventions

Respiratory Muscle Training BEHAVIORAL

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.

Respiratory Muscle Training Group

Exercise BEHAVIORAL

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.

Exercise Group

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Special Education and Rehabilitation Center

You may qualify if:

• 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.

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• Medipol University: lead

MeSH Terms

Conditions

Obesity

Interventions

Breathing Exercises; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Devrim Tarakçı, Prof.

  İstanbul Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Demet Sarıyıldız, MSc, PhD(c)

CONTACT

+905066869182; demet.sariyildiz@std.medipol.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 26, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08