About this trial
Introduction: Childhood obesity can impair postural control, balance, and motor skills, thereby limiting participation in physical activity. Aerobic exercise is widely used to improve cardiovascular fitness and support weight management in children with obesity. In recent years, however, Progressive Neuromuscular Stabilization (PNS) exercises, which aim to retrain the neuromuscular system, have been suggested to have beneficial effects on core stability, balance, and postural control. Technology-assisted exercise interventions may increase children's participation and enhance motivation throughout the rehabilitation process. This study aims to compare the effectiveness of technology-assisted PNS exercises with conventional aerobic exercise in children with obesity.
Methods: This study will be conducted among children attending the Department of Pediatrics, Istanbul University-Cerrahpaşa who meet the eligibility criteria. Children aged 12-18 years with obesity will be recruited. Participants will be randomly allocated into three groups: the Aerobic Exercise (AE) group, the Progressive Neuromuscular Stabilization (PNS) group, and the Control group.
Participants in the exercise groups will receive supervised exercise sessions twice weekly for 12 weeks in a clinical setting and will be instructed to perform home-based exercises on the remaining days. Home exercise programs will be delivered through the BeCure® mobile application, where exercise videos will be uploaded, and participants will be asked to perform progressively advancing exercises on a weekly basis. The control group will receive a single session of exercise counseling. Outcome assessments will be performed before and after the intervention.
Sample Size: The sample size was calculated using G\*Power version 3.1. Based on moderate effect sizes reported in the literature (Lengkana et al., 2019), the effect size was set at f = 0.30, with a significance level of α = 0.05 and statistical power of 1 - β = 0.95. Power analysis for a repeated-measures design with three groups and two measurement time points (baseline and post-intervention) indicated a minimum total sample size of 48 participants. To account for potential dropouts, a total of 54 participants will be recruited. Participants will be assigned to the study groups using block randomization stratified by age and sex.
Primary Outcome Measure:
Balance and postural control will be assessed using the Biodex Balance System.
Secondary Outcome Measures:
Body composition will be evaluated using Body Mass Index (BMI), triceps and subscapular skinfold thickness, waist circumference, and Bioelectrical Impedance Analysis (BIA) to determine body fat percentage. Core muscle endurance will be assessed using the Prone Plank Test and the Side Plank Test. Functional performance will be evaluated using the 6-Minute Walk Test (6MWT), the 30-Second Sit-to-Stand Test (30-s STS), and the 20-Meter Shuttle Run Test.
Physical activity level will be assessed using the Physical Activity Questionnaire for Children (PAQ-C). Self-perception and body image will be evaluated using the Self-Perception Profile for Children (SPPC). Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL), while fatigue will be evaluated using the PedsQL Multidimensional Fatigue Scale. Posture will be assessed using the New York Posture Rating Scale.
Study Plan:
Each exercise session will last approximately 40 minutes, consisting of a 5-minute warm-up, 30 minutes of the main exercise program, and a 5-minute cool-down.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 12 to 18 years
Classified as having Class I obesity (Body Mass Index [BMI] ≥95th percentile and <120% of the 95th percentile for age and sex) or Class II obesity (BMI ≥120% and <140% of the 95th percentile for age and sex), according to the Centers for Disease Control and Prevention (CDC) age- and sex-specific growth charts.
Able to maintain a single-leg stance on the non-dominant leg with eyes closed for less than 30 seconds.
Written informed consent provided by a parent or legal guardian, and assent obtained from the participant.
Disqualifiers
Classified as having Class III obesity (Body Mass Index [BMI] ≥140% of the 95th percentile for age and sex).
Presence of an orthopedic condition that would prevent participation in the exercise program.
History of any injury or surgery within the previous 6 months.
Presence of a chronic neurological disorder.
Trial design
Parallel
Treatments tested in this trial
Progressive Neuromuscular Stabilization Exercise
Other interventionProgressive Neuromuscular Stabilization Exercise Participants will complete a 12-week Progressive Neuromuscular Stabilization (PNS) exercise program consisting of supervised clinical sessions twice weekly and home-based exercises delivered through the BeCure® mobile application. The program is designed to improve core stability, balance, postural control, and neuromuscular coordination through progressively challenging exercises.
Aerobic Exercise
Other interventionAerobic Exercise Participants will complete a 12-week aerobic exercise program consisting of supervised clinical sessions twice weekly and home-based exercises delivered through the BeCure® mobile application. The program includes progressive aerobic activities aimed at improving cardiovascular fitness, physical activity level, and body composition.
Treatment groups
Trial outcomes
Primary outcomes
Change in Overall Stability Index (OSI)
Overall postural stability will be assessed using the Biodex Balance System. Lower scores indicate better postural stability.
Change in Anterior-Posterior Stability Index (APSI)
Anterior-posterior postural stability will be assessed using the Biodex Balance System. Lower scores indicate better stability.
Change in Medial-Lateral Stability Index (MLSI)
Medial-lateral postural stability will be assessed using the Biodex Balance System. Lower scores indicate better stability.
Secondary outcomes
Change in Body Mass Index
Body mass index will be calculated by dividing body weight in kilograms by height in meters squared.
Change in Waist Circumference
Waist circumference will be measured in centimeters using a non-elastic measuring tape.
Change in Skinfold Thickness
Triceps and subscapular skinfold thickness will be measured in millimeters using a skinfold caliper.
Change in Body Fat Percentage
Body fat percentage will be assessed using bioelectrical impedance analysis.
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