Istanbul University- Cerrahpasa
Istanbul, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07744022
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.
Interested in participating?
Request Info12 year–18 year
All sexes
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
Location status: Recruiting
Detailed Study Description Background
Childhood obesity is a major global public health concern associated with numerous adverse health outcomes, including metabolic, cardiovascular, and musculoskeletal disorders. Beyond these well-recognized complications, obesity negatively affects postural control, balance, motor performance, and functional movement capacity. Excess body weight alters biomechanical alignment, shifts the center of gravity, and impairs neuromuscular coordination, thereby increasing postural instability and reducing participation in physical activity. Consequently, children with obesity often develop a sedentary lifestyle, which further exacerbates obesity and its associated health risks.
Aerobic exercise is widely recommended as a first-line intervention for childhood obesity because of its well-established benefits in improving cardiovascular fitness, energy expenditure, body composition, and overall physical health. However, aerobic exercise alone may not sufficiently address deficits in neuromuscular control, postural stability, and core muscle function, which are common in children with obesity.
Progressive Neuromuscular Stabilization (PNS) exercises are based on the principles of developmental kinesiology and progressive motor control training. These exercises aim to improve postural alignment, enhance core stability, optimize neuromuscular coordination, and restore efficient movement patterns through progressively challenging stabilization tasks. Recent evidence suggests that neuromuscular stabilization exercises may improve balance, postural control, movement quality, and functional performance in pediatric populations. Nevertheless, evidence regarding their effectiveness in children with obesity remains limited.
In addition, adherence to long-term exercise programs represents one of the greatest challenges in pediatric obesity management. Technology-assisted exercise interventions delivered through mobile applications may increase exercise adherence by providing structured guidance, visual demonstrations, progressive exercise progression, and continuous motivation. Therefore, integrating technology-supported home exercise programs with supervised clinical sessions may improve treatment compliance and maximize intervention effectiveness.
This randomized controlled trial aims to compare the effects of technology-assisted Progressive Neuromuscular Stabilization exercises and conventional aerobic exercise on balance, postural control, body composition, functional performance, and quality of life in children with obesity.
Methods
This study will be conducted at the Department of Pediatrics, Istanbul University-Cerrahpaşa, among children referred to the pediatric obesity outpatient clinic. Participants meeting the eligibility criteria will be invited to participate after obtaining written informed consent from their parents or legal guardians and assent from the children.
Children aged 12 to 18 years who are classified as obese according to age- and sex-specific criteria will be enrolled. Eligible participants will be randomly assigned using age- and sex-stratified block randomization into one of three study groups:
Progressive Neuromuscular Stabilization (PNS) Exercise Group Aerobic Exercise (AE) Group Control Group
Both intervention groups will participate in a 12-week exercise program, attending supervised clinical exercise sessions twice weekly. Each session will last approximately 40 minutes, including:
5 minutes of warm-up, 30 minutes of the main exercise program, 5 minutes of cool-down exercises.
In addition to supervised sessions, participants in both intervention groups will perform home-based exercises on the remaining weekdays. Home exercise programs will be delivered through the BeCure® mobile application, where exercise videos prepared specifically for each intervention will be uploaded. Participants will be instructed to complete progressively advancing exercise programs each week. Exercise adherence will be monitored through the mobile application, and participants will receive regular follow-up to encourage compliance.
The PNS intervention will consist of progressively challenging exercises targeting diaphragmatic breathing, trunk stabilization, neuromuscular coordination, developmental movement patterns, proprioception, balance, and postural control. Exercise difficulty will increase throughout the intervention by incorporating unstable surfaces, resistance, dual-task activities, and functional movement progression.
The aerobic exercise program will include age-appropriate rhythmic and functional aerobic activities such as walking, stepping, dynamic movement games, and interval-based exercises. Exercise intensity will be progressively increased according to participants' functional capacity throughout the intervention.
Participants allocated to the control group will receive a single standardized exercise counseling session that includes recommendations regarding healthy lifestyle habits and physical activity but will not participate in the supervised exercise intervention.
Outcome assessments will be performed at baseline and immediately after completion of the 12-week intervention period by assessors blinded to group allocation whenever possible.
Sample Size
Sample size was calculated using G*Power version 3.1 based on previously published findings (Lengkana et al., 2019). Assuming a medium effect size (f = 0.30), a significance level of α = 0.05, and a statistical power of 95% (1-β = 0.95), repeated-measures ANOVA with three groups and two assessment time points required a minimum total sample size of 48 participants. Considering potential dropouts during the intervention, the final planned sample size is 54 participants.
Primary Outcome
The primary outcome of the study is balance and postural control, which will be assessed using the Biodex Balance System. Static and dynamic postural stability indices, including the Overall Stability Index (OSI), Anterior-Posterior Stability Index (APSI), and Medial-Lateral Stability Index (MLSI), will be recorded.
Secondary Outcomes
Secondary outcome measures include:
Body composition Body Mass Index (BMI) Waist circumference Triceps skinfold thickness Subscapular skinfold thickness Body fat percentage measured by Bioelectrical Impedance Analysis (BIA) Core muscle endurance Prone Plank Test Side Plank Test Functional performance 6-Minute Walk Test (6MWT) 30-Second Sit-to-Stand Test 20-Meter Shuttle Run Test Physical activity level Physical Activity Questionnaire for Children (PAQ-C) Self-perception and body image Self-Perception Profile for Children (SPPC) Health-related quality of life Pediatric Quality of Life Inventory (PedsQL) Fatigue Pediatric Quality of Life Inventory Multidimensional Fatigue Scale Postural assessment New York Posture Rating Scale Expected Significance
This study will provide evidence regarding the comparative effectiveness of technology-assisted Progressive Neuromuscular Stabilization exercises and conventional aerobic exercise in children with obesity. The findings may contribute to the development of more comprehensive rehabilitation strategies that not only improve body composition but also enhance balance, postural control, neuromuscular function, functional capacity, and exercise adherence. Furthermore, integrating mobile application-based home exercise programs into pediatric obesity rehabilitation may offer a practical and sustainable approach for increasing long-term participation in physical activity and improving treatment outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Progressive 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
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.
Time frame: Baseline and post-intervention (Week 12)
Overall postural stability will be assessed using the Biodex Balance System. Lower scores indicate better postural stability.
Time frame: Baseline and post-intervention (Week 12)
Anterior-posterior postural stability will be assessed using the Biodex Balance System. Lower scores indicate better stability.
Time frame: Baseline and post-intervention (Week 12)
Medial-lateral postural stability will be assessed using the Biodex Balance System. Lower scores indicate better stability.
Time frame: Baseline and post-intervention (Week 12)
Body mass index will be calculated by dividing body weight in kilograms by height in meters squared.
Time frame: Baseline and post-intervention (Week 12)
Waist circumference will be measured in centimeters using a non-elastic measuring tape.
Time frame: Baseline and post-intervention (Week 12)
Triceps and subscapular skinfold thickness will be measured in millimeters using a skinfold caliper.
Time frame: Baseline and post-intervention (Week 12)
Body fat percentage will be assessed using bioelectrical impedance analysis.
Time frame: Baseline and post-intervention (Week 12)
Core muscle endurance will be assessed by recording the maximum time, in seconds, that the participant can maintain the prone plank position with correct alignment.
Time frame: Baseline and post-intervention (Week 12)
Lateral core muscle endurance will be assessed by recording the maximum time, in seconds, that the participant can maintain the side plank position.
Time frame: Baseline and post-intervention (Week 12)
Functional exercise capacity will be assessed by measuring the total distance, in meters, walked during the 6-Minute Walk Test.
Time frame: Baseline and post-intervention (Week 12)
Lower-extremity functional performance will be assessed by recording the number of correctly completed sit-to-stand repetitions within 30 seconds.
Time frame: Baseline and post-intervention (Week 12)
Cardiorespiratory fitness will be assessed using the 20-Meter Shuttle Run Test. Performance will be recorded according to the number of completed stages, laps, or total distance.
Time frame: Baseline and post-intervention (Week 12)
Physical activity level will be assessed using the Physical Activity Questionnaire for Children. Higher scores indicate a higher level of physical activity.
Time frame: Baseline and post-intervention (Week 12)
Self-perception will be assessed using the Self-Perception Profile for Children. Higher scores indicate more positive self-perception.
Time frame: Baseline and post-intervention (Week 12)
Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory. Higher scores indicate better health-related quality of life.
Time frame: Baseline and post-intervention (Week 12)
Fatigue will be assessed using the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale. Higher scores indicate fewer fatigue-related problems.
Time frame: Baseline and post-intervention (Week 12)
Posture will be assessed using the New York Posture Rating Scale. Higher scores indicate better postural alignment.
Contact information is provided by the study sponsor or research team.
Ela Tarakcı, Professor
CONTACT
Emine Dilek Kurbaloğlu, PhD Student
CONTACT
Istanbul University - Cerrahpasa
Other
Effects of Progressive Neuromuscular Stabilization Exercises Versus Aerobic Exercises on Body Composition and Postural Balance in Children With Obesity: A Randomized Controlled Trial
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.
Published trials that share one or more normalized conditions with this study.
NCT07467694
Behavior, Body Weight
Boston, Massachusetts, United States
View Trial DetailsNCT06918821
Behavior, Body Weight
Houston, Texas, United States
View Trial DetailsNCT06931730
Behavior, Body Weight
Rome, Italy
View Trial DetailsNCT07176234
Behavior, Body Weight
Columbia, South Carolina, United States
View Trial Details