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临床试验/NCT07073651
NCT07073651已完成不适用

Response of Lipid Profile to Virtual Reality Games Versus Moderate Aerobic Exercise Training in Children With Obesity

Badr University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
High Density Lipoproteins (HDL)

研究概览

简要总结

This trial is aiming to study the effect of virtual reality video gaming in comparison with moderate intensity aerobic exercises on lipid profile in children with Obesity

详细描述

The study will assess whether virtual reality games, dietary advices and moderate intensity aerobic exercise lead to significant differences in lipid profile in class I obese adolescent children. Additionally, the study will examine whether these interventions has impacts on the children body mass index.

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
11 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Obese adolescent children
  • •age from 11 to 18 years old only.
  • •Class I Obesity (Body Mass Index from 30 to 34.99 kg/m2)
  • •Clinically and medically stable
  • •Without any impairment of sensation or other neurological or psychological problems.

排除标准

  • •Adolescents with visual and/or auditory defects
  • •Normal weight adolescent children (Body Mass Index from 18 to 24.99 kg/m2) or below average weight (BMI less than 18 kg/m2) or Class II and III Obesity (BMI above 35 kg/m2)
  • •Children with significant tightness and/or deformity of upper or lower limbs
  • •Participants with neurological disorders that affect balance or mentality (e.g. epilepsy).
  • •Adolescents with advanced radiographic changes include: Bone destruction, Bony ankylosis, Knee joint subluxation, and Epiphysial fracture)
  • •Any lower limb deformities in the lower limbs.
  • •Participants with cardiopulmonary diseases.
  • •Diabetic children or those under insulin therapy, uncontrolled bronchial asthma, anemia, and Pathological causes of obesity (endocrinal, genetic syndromes...etc.).

研究组 & 干预措施

Virtual Reality Exercise

Experimental

The experimental group included 60 adolescent obese children of both genders (class I obesity, BMI: 30-34.99) who received diet advices and virtual reality exercises 5 times per week for 12 weeks. Each participating child started the session with 5 minutes warming up exercises then followed by the main part which was consisted of 30 min of exercise where the child played the game using virtual reality X-Box and did different physical activities that included both the upper and lower extremities according to the game's requirements, and after that a 5 min cool-down part that involved some static flexibility exercise to allow the heart rate to lower, the total session that would be applied about 40 min (including 30 mins of Virtual reality exercises)

干预措施: Dietary Advices (Other)

Virtual Reality Exercise

Experimental

The experimental group included 60 adolescent obese children of both genders (class I obesity, BMI: 30-34.99) who received diet advices and virtual reality exercises 5 times per week for 12 weeks. Each participating child started the session with 5 minutes warming up exercises then followed by the main part which was consisted of 30 min of exercise where the child played the game using virtual reality X-Box and did different physical activities that included both the upper and lower extremities according to the game's requirements, and after that a 5 min cool-down part that involved some static flexibility exercise to allow the heart rate to lower, the total session that would be applied about 40 min (including 30 mins of Virtual reality exercises)

干预措施: Virtual reality games exercise (Other)

Moderate intensity aerobic exercise

Active Comparator

This group serves as the control group, it included 60 adolescent obese children of both genders (class I obesity, BMI: 30-34.99) who received diet advice and moderate intensity aerobic exercises (using treadmill training) 5 times per week for 12 weeks. Each participating child started the session with 5 minutes of warming-up exercises. Then the main exercise phase is performed at 50-60% of age-predicted peak heart rate using a treadmill for 30 minutes. Finally, a 5 min cool-down period is allowed, the total session took 40 minutes.

干预措施: Moderate Intensity Aerobic Exercise (Other)

Moderate intensity aerobic exercise

Active Comparator

This group serves as the control group, it included 60 adolescent obese children of both genders (class I obesity, BMI: 30-34.99) who received diet advice and moderate intensity aerobic exercises (using treadmill training) 5 times per week for 12 weeks. Each participating child started the session with 5 minutes of warming-up exercises. Then the main exercise phase is performed at 50-60% of age-predicted peak heart rate using a treadmill for 30 minutes. Finally, a 5 min cool-down period is allowed, the total session took 40 minutes.

干预措施: Dietary Advices (Other)

结局指标

主要结局

High Density Lipoproteins (HDL)

时间窗: From enrollment to the end of treatment at 12 weeks

High Density Lipoproteins (HDL) cholesterol fats are measured in laboratory using a venous blood sample

Low Density Lipoproteins (LDL)

时间窗: From enrollment to the end of treatment at 12 weeks

Low Density Lipoproteins (LDL) cholesterol fats are measured in laboratory using a venous blood sample

Body mass index

时间窗: From enrollment to the end of treatment at 12 weeks

It is the weight (in kilograms) divided by the height (in meter squares)

Serum triglycerides

时间窗: From enrollment to the end of treatment at 12 weeks

Level of triglycerides fats in blood in measured in laboratory using venous blood sample

Total Cholesterol

时间窗: From enrollment to the end of treatment at 12 weeks

Level of total cholesterol in blood in measured in laboratory using venous blood sample

次要结局

  • HDL ratio(From enrollment to the end of treatment at 12 weeks)

研究者

发起方
Badr University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mina Atef Georgui Elias

Lecturer

Badr University

研究点 (2)

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