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NCT Number: NCT07787546

The Effectiveness of Respiratory Muscle Training and Exercise in Obese Adolescents

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.

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Key information

Conditions

Obesity (Disorder) Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Respiratory muscle training

Behavioral
  • 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

Behavioral
  • 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

  3. 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.

  4. 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.

    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.

  5. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Demet Sarıyıldız, MSc, PhD(c)

CONTACT

[email protected]

+905066869182

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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