Effects of Progressive Neuromuscular Stabilization Exercises Versus Aerobic Exercises on Body Composition and Postural Balance in Children With Obesity
报名条件(概要)
- 年龄:12 Years – 18 Years
- 性别:不限
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
Turkey (Türkiye)
药品与企业信息
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.
研发企业
试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。
研究简介(原文)
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.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人(申办方/研究总部)
- Emine Dilek Kurbaloğlu, PhD Studentfzt.edilek@gmail.com+905416258918
- Ela Tarakcı, Professoretarakci@iuc.edu.tr+905422175730
研究中心联系方式
- Istanbul University- CerrahpasaIstanbul,Turkey (Türkiye)
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英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Effects of Progressive Neuromuscular Stabilization Exercises Versus Aerobic Exercises on Body Composition and Postural Balance in Children With Obesity ClinicalTrials.gov Identifier: NCT07744022 Sponsor: Istanbul University - Cerrahpasa Investigational product: Progressive Neuromuscular Stabilization Exercise, Aerobic Exercise About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:Effects of Progressive Neuromuscular Stabilization Exercises Versus Aerobic Exercises on Body Composition and Postural Balance in Children With Obesity 试验编号:NCT07744022 申办方:Istanbul University - Cerrahpasa 研究药物:Progressive Neuromuscular Stabilization Exercise、Aerobic Exercise 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。