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临床试验/NCT02240147
NCT02240147已完成不适用

Start-to-Sport - Feasibility and Efficacy of Individualized, Telemonitored, Home-based Exercise for Adolescents and Adults With Congenital Heart Disease

KU Leuven1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年1月1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
KU Leuven
入组人数
60
试验地点
1
主要终点
peak oxygen uptake

研究概览

简要总结

Almost 1% of all baby's is born with a heart defect (CHD) and most of them survive. Even though outcomes are good, they need lifelong follow-up because of a higher risk for cardiovascular diseases. Studies have shown that patients with CHD are not active enough and that a substantial amount of patients is overweight. Hence preventive strategies and education should not only focus on the heart problem, but also on a healthy lifestyle including physical activity. Recently a new guideline introduced exercise prescription based on the absence/presence of certain key elements. However, a number of important questions remain that preclude implementation in clinical practice. Therefore a 'Start-to-Sport' program for adults with CHD, based on this new guideline, will be investigated. This study is a randomized controlled trial that investigates the effects of the program on daily physical activity, exercise capacity, quality of life and exercise self-efficacy both in short (12 weeks) and long (52 weeks) term, along with possible mechanisms for the training effects by using a new exercise-testing protocol that looks simultaneously to all body parts that are involved during exercise. Ultimately, our findings will result in the implementation of the guideline in clinical practice.

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
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adolescents and adults with congenital heart disease
  • 16 to 65 years

排除标准

  • congenital rhythm or conduction disorders
  • isolated congenital coronary artery anomalies
  • pregnancy
  • being listed for heart transplantation
  • inability to perform standard physical activities due to mental/physical disability.

结局指标

主要结局

peak oxygen uptake

时间窗: baseline, post-intervention, after 1 year

次要结局

  • physical activity(baseline, post-intervention and after 1 year)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roselien Buys

Dr.

KU Leuven

研究点 (1)

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