Introduction
CHD
RECRUITMENT
Active play is critically important for young children [Although most older children and adults with simple or complex CHD are more sedentary than healthy peers [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 compliance, and the willingness of patients to be randomized to either intervention or control conditions are required to calculate an appropriate randomized controlled trial (RCT) sample size. Data on the time to contact, enroll, and assess patients, as well as the time required to develop and implement each child’s intervention are required in addition to data on withdrawal and ineligibility rates.To prepare for an RCT examining the efficacy of a 6-month intervention during the treatment and post-treatment recovery phase of infants with CHD, this study is evaluating the feasibility of participant recruitment, data collection procedures and outcome measures, the acceptability and suitability of the intervention, and the resources required. We are also gathering preliminary efficacy evidence of response to the intervention, and professional and parent perceptions of study burden. This feasibility trial is also designed to reveal unforeseen problems and provide an opportunity to find appropriate solutions that would optimize the RCT design. We hypothesize that it will be feasible to recruit patients, collect data and perform the outcome measures of the intervention. We also hypothesize that parents will not feel burdened by the study. Furthermore, we hypothesize that the 6-month, home-based, parent-led, kinesiologist-designed physical activity program, completed immediately after surgical or catheterization treatment, may enable young children with CHD to achieve the recommended 180 minutes of daily physical activity.