Ramanan Neya, Lee Suzie, Maharajh Gyaandeo, Webster Richard, Longmuir Patricia E
Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada.
Faculty of Science, University of Ottawa, Ottawa, Canada.
PLoS One. 2023 Aug 18;18(8):e0284946. doi: 10.1371/journal.pone.0284946. eCollection 2023.
Children with congenital heart disease (CHD) often have inactive lifestyles and motor skill deficits beginning in infancy. The least active infants continue to be the least active children at school age. Enhancing physical activity and motor development in infancy, at the time of CHD treatment, may prevent inactive lifestyle habits.
All children being treated, through surgery or catheterization, for congenital heart disease are eligible if they are 3 to 72 months of age at enrollment. The Peabody Motor Development Scales (Version 2) and 7-day accelerometry (Actigraph GT9X Link) assess motor skills and physical activity prior to treatment and 7 weeks, 6 months and 12 months post-treatment. Participants are randomized 3:1 to intervention:control. Until 7 weeks post-treatment, intervention activities focus on regaining pre-treatment mobility and midline crossing. From 7 weeks to 6 months post-treatment, the intervention is individualized to each child's assessment results and is parent-led, delivered at home and play-based.
This feasibility study will provide essential data for a randomized controlled trial to evaluate play-based, parent-delivered interventions optimized to support age-appropriate physical activity and motor skills among young children with CHD. Preliminary intervention efficacy data will inform an evidence-based sample size calculation, optimize intervention timing, and identify hypotheses on the motor skill-physical activity connection and the impact of play-based, parent-led interventions during recovery from CHD treatment. Long-term, the goal is to optimize motor skill and active lifestyles among young children with CHD, enabling their healthy growth and development and enhancing childhood quality of life.
Clinical trials registration: NCT04619745.
先天性心脏病(CHD)患儿通常从婴儿期就开始有不活跃的生活方式和运动技能缺陷。最不活跃的婴儿在学龄期仍是最不活跃的儿童。在CHD治疗时增强婴儿期的身体活动和运动发育,可能预防不活跃的生活习惯。
所有因先天性心脏病接受手术或导管介入治疗的儿童,若入组时年龄在3至72个月,则符合条件。使用皮博迪运动发育量表(第2版)和7天加速度计(Actigraph GT9X Link)在治疗前以及治疗后7周、6个月和12个月评估运动技能和身体活动。参与者按3:1随机分为干预组和对照组。在治疗后7周之前,干预活动侧重于恢复治疗前的活动能力和中线交叉。从治疗后7周至6个月,干预根据每个孩子的评估结果进行个性化定制,由家长主导,在家中进行且以游戏为基础。
这项可行性研究将为一项随机对照试验提供重要数据,以评估基于游戏、由家长实施的干预措施,这些措施经过优化,以支持CHD幼儿进行适合其年龄的身体活动和运动技能发展。初步的干预效果数据将为基于证据的样本量计算提供信息,优化干预时机,并确定关于运动技能与身体活动之间的联系以及基于游戏、家长主导的干预措施在CHD治疗恢复过程中的影响的假设。从长远来看,目标是优化CHD幼儿的运动技能和积极的生活方式,促进他们的健康成长和发育,并提高儿童期生活质量。
临床试验注册编号:NCT04619745。