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临床试验/NCT04868331
NCT04868331已完成不适用

Evaluation of Cardiovascular Responses in Adolescent Idiopathic Scoliosis (AIS) Girls Performing E-Fit Exercise Intervention: a Pilot Study

Tung Wah College1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Oximetry

研究概览

简要总结

The aims of this pilot study are to determine the metabolic demand and exercise intensity level of E-Fit exercise intervention by evaluating the cardiovascular responses in AIS girls and whether the cardiovascular responses for AIS girls performing E-Fit will behave in the same way as compared to healthy controls. We hypothesise that 1) the metabolic demand and exercise intensity of E-Fit exercise intervention is equivalent to moderate-to-vigorous level; and 2) AIS girls have different cardiovascular responses as compared to healthy controls

详细描述

AIS girls and age- and gender-matched healthy controls will perform the E-Fit exercise intervention for two trials and gas exchange parameters including oxygen consumption (VO2) and carbon dioxide production (VCO2) will be taken continuously during the exercise. Comparison of VO2 and VCO2 between AIS and healthy controls when performing E-Fit exercise will be made.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Cobb angle greater or equal to 15 degree
  • Cleared for physical activity by doctor

排除标准

  • Cobb angle greater or equal to 40 degree, or
  • Scoliosis with any known etiology, scoliosis with skeletal dysplasia, know endocrine and connective tissue abnormalities, or
  • Known heart condition or other diseases that could affect the safety of exercise, or
  • Eating disorders or GI malabsorption disorders, or
  • Currently taking medication that affects bone or muscle metabolism

结局指标

主要结局

Oximetry

时间窗: Day 1

Peripheral capillary oxygen saturation (%) will be measured using a fingertip oximeter.

Respiratory gas measurement

时间窗: Day 1

Breath-by-breath measurement of cardiorespiratory and gas exchange parameters to analyse oxygen consumption (VO2 in ml/min) and carbon dioxide production (VCO2 in ml/min).

Blood Pressure

时间窗: Day 1

Blood pressure (mmHg) will be measured using an electronic sphygmomanometer.

Heart rate

时间窗: Day 1

Heart rate (bpm) will be measured using a fingertip oximeter.

次要结局

  • Modified Baecke Questionnaire(Day 1)
  • Body Composition(Day 1)
  • Sitting height(Day 1)
  • Arm Span(Day 1)
  • Maturity assessment(Day 1)
  • Physical Activity Rating Questionnaire for Children and Youth (PARCY)(Day 1)
  • Body height(Day 1)

研究者

发起方
Tung Wah College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rufina Lau

Senior Lecturer

Tung Wah College

研究点 (1)

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