Preventing sedentary lifestyles among young children born with congenital heart defects: A feasibility study of physical activity rehabilitation after surgical or catheterization intervention

PLOS ONE STUDY PROTOCOL Preventing sedentary lifestyles among young children born with congenital heart defects: A feasibility study of physical activity rehabilitation after surgical or catheterization intervention a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 Neya Ramanan ID1,2, Suzie Lee1,3,4, Gyaandeo Maharajh1,4,5, Richard Webster1, Patricia E. Longmuir ID1,4,6* 1 Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Canada, 2 Faculty of Science, University of Ottawa, Ottawa, Canada, 3 Division of Cardiology, Children’s Hospital of Eastern Ontario, Ottawa, Canada, 4 Faculty of Medicine, University of Ottawa, Ottawa, Canada, 5 Division of Cardiovascular Surgery, Children’s Hospital of Eastern Ontario, Ottawa, Canada, 6 Faculty of Health Sciences, University of Ottawa, Ottawa, Canada * OPEN ACCESS Citation: Ramanan N, Lee S, Maharajh G, Webster R, Longmuir PE (2023) Preventing sedentary lifestyles among young children born with congenital heart defects: A feasibility study of physical activity rehabilitation after surgical or catheterization intervention. PLoS ONE 18(8): e0284946. https://doi.org/10.1371/journal. pone.0284946 Editor: Dario Ummarino, PhD, PLOS, UNITED KINGDOM Abstract Background 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. Received: October 14, 2022 Methods Accepted: April 11, 2023 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. Published: August 18, 2023 Copyright: © 2023 Ramanan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion. Funding: Funding for this research was provided by the Canadian Institutes for Health Research (grant # 202104PJT-461792-CID-CECC-158683) and the Heart and Stroke Foundation of Canada (grant # G-20- 0028713) to Principal Investigator Conclusion 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 PLOS ONE | https://doi.org/10.1371/journal.pone.0284946 August 18, 2023 1/9 PLOS ONE Dr. Longmuir. The study was prospectively registered in ClinicalTrials.gov (NCT04619745). The trial has been approved by the Research Ethics Board of the Children’s Hospital of Eastern Ontario (REB file #20/67X, version 1, 2021-11-16) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Sedentary lifestyle prevention protocol for young children with congenital heart defects 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. Trial registration Clinical trials registration: NCT04619745. Competing interests: The authors have declared that no competing interests exist. Introduction Active play is critically important for young children [1–5] as it is the foundation for childhood socialization, provides emotional, psychological and cognitive benefits [5] and is essential for childhood health [6], and biological and psychosocial development [1, 5]. Children with simple or complex congenital heart defects (CHD) are often less active [7], unable to achieve the 180 mins of daily activity recommended for the optimal health of young children [8], even when these children have age-appropriate motor skills [9, 10]. Highly inactive infants with CHD become the most inactive school age children [11], suggesting that an effective intervention to enhance active play should target children with CHD in infancy. Although most older children and adults with simple or complex CHD are more sedentary than healthy peers [12–14], a small proportion of these patients lead active lifestyles [15, 16] and exercise [17], fitness [18, 19], or movement skill training [17] improves their performance. Therefore, their sedentary behavior is unlikely to result from physiological limitations of the cardiac diagnosis. The hypoactive lifestyles [14] among children with simple or complex CHD are suggested to result from limited self-efficacy for physical activity [20], parental overprotection [21] or perceptions of the child as fragile [14, 17]. Uncertainty naturally leads to caution, and eventually a more sedentary lifestyle. Given the difficulty in altering established habits, few interventions to enhance active lifestyles among older children with CHD have demonstrated long-term benefits [18]. Interventions that target young children are required so that active lifestyles can be established before sedentary lifestyle habits emerge. The development of an intervention targeting physical activity in very young children with CHD would be highly novel, with several theoretical issues identified. Most importantly, it is necessary to determine whether parents would be willing to have their children participate. It is unclear whether parents of younger infants and those with less severe forms of CHD would be willing to enroll in a 6-month intervention at the time of treatment (i.e., recruitment feasibility). There is also evidence needed to support the feasibility, and parent and healthcare professional acceptance of completing recruitment and baseline assessments within the 4-to-6 week interval between scheduling of treatment and treatment date. Data on intervention efficacy and complianc (...truncated)