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临床试验/CTRI/2024/07/069960
CTRI/2024/07/069960尚未招募不适用

Effectiveness of aerobic exercise intervention in overweight and obesity childern with Neurodevelopmental disorders

Samudytha K.M1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
BMI- Body Mass Index

研究概览

简要总结

The study focuses on children aged 5-15 diagnosed with neurodevelopmental disorders, aiming to evaluate the effects of a structured exercise program. Before commencing, parental consent and demographic data are obtained, including weight and height measurements. Maximum heart rate (HRmax) is calculated using the formula HRmax = 208 - age (0.8).

Each session, lasting 60 minutes, occurs 3 days per week over 12 weeks. It begins with a 10-minute warm-up comprising walking, upper and lower body exercises, and passive stretching. Following this, a 20-minute strengthening segment includes exercises like biceps curls and hip extensions. Intensity increases progressively every 3 weeks.

Aerobic exercises such as treadmill and cycling follow, starting at 65% of HRmax and progressing to 75% by week 12. Sessions conclude with a 7-minute cooldown involving overall body stretching and deep breathing.

Ethical clearance is obtained, and data collection occurs at pediatric physiotherapy OPDs and special schools in Hubli-Dharwad. The study uses a paired t-test to assess baseline and post-intervention outcomes, tailored to each participant’s condition.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Children falling in the age group of 5-15 years Subjects who are overweight and obesity whose BMI is more or equal to 85th percentile Children who confirmed with NDD by the pediatrician The children who can follow the simple commands The children whose parents are willing their child’s participation.

排除标准

  • the children who are unable to walk the children, whose parents are not willing their child’s participation.
  • the children who are less than 5 years of age.
  • The children who are diagnosed with congestive Heart failure, vascular disease, renal disorders.

结局指标

主要结局

BMI- Body Mass Index

时间窗: BMI- Body Mass Index is calculated at 0 day 4th week 8th week and 12th week of intervention

次要结局

  • waist circumference
  • PeDsQL measure(is a 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18. this is taken at 0th day and 12th week of intervention)

研究者

发起方
Samudytha K.M
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Samudyatha KM

SDM college of physiotherapy

研究点 (1)

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