Clinical trial

The Effectiveness of Respiratory Muscle Training and Exercise in Obese Adolescents

Opening soon · Not applicable · 0 countries · Registry ID NCT07787546

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age10 Years to 16 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity (Disorder)

Full registry criteria

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).

Treatments and study arms

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.

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.

Primary outcomes

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

Study locations

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No public site location was included in this record. Check the original registry for updates.