Meyer Michael, Hreinsdottir Adalheidur, Häcker Anna-Luisa, Brudy Leon, Oberhoffer Renate, Ewert Peter, Müller Jan
Department of Pediatric Cardiology and Congenital Heart Disease, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Department of Sport and Health Sciences, Institute of Preventive Pediatrics, Technische Universität München, Munich, Germany.
Front Pediatr. 2018 Aug 27;6:224. doi: 10.3389/fped.2018.00224. eCollection 2018.
Exercise interventions are underutilized in children with congenital heart disease (CHD) especially when the primary outcome is not peak oxygen uptake. Most of the studies are restricted to a low sample size and proximity of the patients to the study centers. Now eHealth approaches bear a promising but also challenging opportunity to transmit such intervention programs to participants, and check progress and compliance from remote. This study will aim to improve health-related physical fitness (HRPF) with a 24 weeks web-based exercise intervention. The current study is planned as a randomized control trial (RCT) with a crossover design and the aim to improve functional outcome measures. It also estimates adherence and feasibility in patients with CHD in this web-based exercise/motor intervention over 24 weeks. Primary outcome will be the improvement of HRPF. Secondary outcomes are, functional and structural arterial stiffness measures and health-related quality of life. Thus, 70 children from 10 to 18 years with CHD of moderate and complex severity will be recruited and allocated randomly 1:1 in two study arms after baseline testing for their HRPF, arterial stiffness measures and health-related quality of life. For 24 weeks, participants in the intervention arm will receive three weekly exercise video clips of 20 min each. Every video clip comprises 20 child-oriented exercises which have to be executed for 30 s followed by a recovery period of 30 s. Each session will start with 3-4 warming-up exercises, followed by 10-12 strength and flexibility exercises, and ending with 3-4 min of cool down or stretching tasks. Continuous video clips will be streamed from a web-based e-Learning platform. The participant simply has to imitate the execution and follow some short advices. After each session, a brief online survey will be conducted to assess perceived exertion and feasibility. The study will help to determine the efficacy and applicability of a web-based exercise intervention in children with CHD in regard to functional outcome measures. In addition, it will outline the effectiveness of remote monitoring, which provides a cost effective approach to reach patients with CHD that are low in prevalence and often do not live in close proximity to their tertiary center. https://ClinicalTrials.gov Identifier: NCT03488797.
运动干预在先天性心脏病（CHD）患儿中未得到充分利用，尤其是当主要结局不是峰值摄氧量时。大多数研究样本量较小，且患者与研究中心距离较近。如今，电子健康方法为将此类干预计划传递给参与者，并远程检查进展和依从性带来了一个充满希望但也具有挑战性的机会。本研究旨在通过为期24周的基于网络的运动干预来改善与健康相关的体能（HRPF）。当前研究计划为一项采用交叉设计的随机对照试验（RCT），旨在改善功能结局指标。它还评估了24周内接受基于网络的运动/运动干预的CHD患者的依从性和可行性。主要结局将是HRPF的改善。次要结局包括功能性和结构性动脉僵硬度指标以及与健康相关的生活质量。因此，将招募70名年龄在10至18岁之间、患有中度和复杂严重程度CHD的儿童，并在对他们的HRPF、动脉僵硬度指标和与健康相关的生活质量进行基线测试后，以1:1的比例随机分配到两个研究组。在24周内，干预组的参与者将每周收到三个时长各为20分钟的运动视频片段。每个视频片段包含20项面向儿童的运动，每项运动需执行30秒，随后有30秒的恢复期。每次训练将从3 - 4项热身运动开始，接着是10 - 12项力量和柔韧性运动，最后以3 - 4分钟的放松或伸展任务结束。连续的视频片段将从基于网络的电子学习平台流式传输。参与者只需模仿动作并遵循一些简短的建议。每次训练后，将进行一次简短的在线调查，以评估主观用力程度和可行性。该研究将有助于确定基于网络的运动干预对CHD患儿功能结局指标的有效性和适用性。此外，它将概述远程监测的有效性，远程监测提供了一种经济有效的方法来接触患病率较低且通常不住在三级中心附近的CHD患者。https://ClinicalTrials.gov标识符：NCT03488797
