Effects of Progressive Neuromuscular Stabilization Exercises Versus Aerobic Exercises on Body Composition and Postural Balance in Children With Obesity: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Overall Stability Index (OSI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Willing and able to participate in the study.
排除标准
- •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.
- •Presence of a psychiatric disorder.
- •Presence of a severe cognitive impairment.
- •Presence of cardiovascular disease.
结局指标
主要结局
Change in Overall Stability Index (OSI)
时间窗: Baseline and post-intervention (Week 12)
Overall postural stability will be assessed using the Biodex Balance System. Lower scores indicate better postural stability.
Change in Anterior-Posterior Stability Index (APSI)
时间窗: Baseline and post-intervention (Week 12)
Anterior-posterior postural stability will be assessed using the Biodex Balance System. Lower scores indicate better stability.
Change in Medial-Lateral Stability Index (MLSI)
时间窗: Baseline and post-intervention (Week 12)
Medial-lateral postural stability will be assessed using the Biodex Balance System. Lower scores indicate better stability.
次要结局
- Change in Body Mass Index(Baseline and post-intervention (Week 12))
- Change in Waist Circumference(Baseline and post-intervention (Week 12))
- Change in Skinfold Thickness(Baseline and post-intervention (Week 12))
- Change in Body Fat Percentage(Baseline and post-intervention (Week 12))
- Change in Prone Plank Duration(Baseline and post-intervention (Week 12))
- Change in Side Plank Duration(Baseline and post-intervention (Week 12))
- Change in 6-Minute Walk Test Distance(Baseline and post-intervention (Week 12))
- Change in 30-Second Sit-to-Stand Test(Baseline and post-intervention (Week 12))
- Change in 20-Meter Shuttle Run Performance(Baseline and post-intervention (Week 12))
- Change in Physical Activity Level(Baseline and post-intervention (Week 12))
- Change in Self-Perception(Baseline and post-intervention (Week 12))
- Change in Health-Related Quality of Life(Baseline and post-intervention (Week 12))
- Change in Fatigue(Baseline and post-intervention (Week 12))
- Change in Posture(Baseline and post-intervention (Week 12))
研究者
Emine Dilek Kurbaloğlu
Principal Investigator
Istanbul University - Cerrahpasa