Optimizing Health Among Children With Congenital Heart Defects
Optimizing Health Among Children With Congenital Heart Defects Through Rehabilitation Focused on Physical Activity Determinants
研究概览
详细说明
Therefore, we hypothesize that psychosocial factors are important determinants of PAP in this population. Our most recent research with children who have univentricular heart indicates that gross motor skill and psychosocial factors are significant correlates of PAP. Important psychosocial factors include self-efficacy for activity, uncertainty about activity, and inaccurate perceptions of the child's PAP level, options, and abilities. This study seeks to determine whether gross motor skill and psychosocial factors influence PAP among children with a broad spectrum of cardiac defects. It will also determine the optimal changes to clinical care needed to encourage children with heart defects to develop health-related active lifestyles.
We propose a prospective, randomized, cross-over preliminary clinical trial utilizing both quantitative and qualitative assessments. Through the cross-over design, each subject will complete both interventions (information, demonstration), with the order of intervention delivery randomly determined. Quantitative assessments will document moderate-to-vigorous physical activity (MVPA), gross motor skill, and health-related fitness. Qualitative assessments will evaluate parent/child anxiety about PAP and psychosocial factors influencing PAP. All factors will be assessed at each data collection point.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大
- The Hospital for Sick Children
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Successful repair of one of the following congenital heart defects: transcatheter device closure of atrial septal defect (ASD), arterial switch repair of transposition of the great arteries (TGA), surgical repair of tetralogy of Fallot (TOF), or Fontan procedure for a functionally univentricular heart (UVH).
- At least one year after most recent open heart surgery.
- 4 to 11 years of age and attending elementary school at first study visit.
Exclusion Criteria:
- Identification of exercise contraindications/limitations by the responsible cardiologist.
- Other disabilities or medical conditions that may influence PAP. Children who achieve 90 minutes of MVPA on 5 or more days per week during the baseline assessment will be excluded from the intervention phase. The study interventions are not designed to increase MVPA among children who already achieve the Health Canada guidelines for PAP.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:第 1 组
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The information intervention is designed to ensure that the parent(s) and child have a clear understanding of the range of physical activity opportunities that are appropriate and recommended for the child.
The information intervention will be comprised of discussions and written information.
The demonstration intervention will be designed to demonstrate to the child and parent(s) specifically what the child is able to do in relation to fitness and motor skill activities.
The demonstration intervention will consist of having the child complete a standardized exercise testing protocol on the treadmill, followed by discussions with the child and parent(s) to convey the results of the study testing of fitness and gross motor skill.
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有源比较器:第 2 组
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The information intervention is designed to ensure that the parent(s) and child have a clear understanding of the range of physical activity opportunities that are appropriate and recommended for the child.
The information intervention will be comprised of discussions and written information.
The demonstration intervention will be designed to demonstrate to the child and parent(s) specifically what the child is able to do in relation to fitness and motor skill activities.
The demonstration intervention will consist of having the child complete a standardized exercise testing protocol on the treadmill, followed by discussions with the child and parent(s) to convey the results of the study testing of fitness and gross motor skill.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Difference in change of measured moderate-to-vigorous physical activity (MVPA) between groups
大体时间:Baseline, 4, 8 and 12 month timepoints
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Baseline, 4, 8 and 12 month timepoints
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Gross motor skill
大体时间:Baseline, 4, 8 and 12 month timepoints
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Baseline, 4, 8 and 12 month timepoints
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Psychosocial variables
大体时间:Baseline, 4, 8 and 12 month timepoints
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Baseline, 4, 8 and 12 month timepoints
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Health-related fitness
大体时间:Baseline, 4, 8 and 12 month timepoints
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Baseline, 4, 8 and 12 month timepoints
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合作者和调查者
调查人员
- 首席研究员:Brain W McCrindle, MD、The Hospital for Sick Children
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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