In-Clinic Activity Promotion for Children With Congenital Heart Disease: Randomized Clinical Trial

Abstract Background An effective in-clinic physical activity counseling intervention is needed to increase physical activity motivation and participation among children with moderate or severe congenital heart disease and enable clinicians to comply with activity promotion recommendations. Methods This pragmatic, single-blind multicenter randomized clinical trial evaluated the intervention feasibility/efficacy among children aged 5-17 years. Clinicians delivered key messages, encouraged activity questions and discussion, and provided kinesiologist support. The primary outcome was daily activity (PiezoRx pedometer steps), assessed after the clinic visit and then monthly for 6 months. Clinic visit length, % counseled, patient/family perceptions, and kinesiology referral assessed health care system impacts. Results A total of 155 children (60 female, 10.8 ± 3.6 years of age) with moderate (n = 119) or severe (n = 36) diagnoses were included in this study. Initial daily step counts, adjusted for age, did not differ between the groups (mean difference=776 ± 515 steps per day, P = 0.13). Typically active intervention participants' mean daily steps over 6 months (adjusted for baseline age, sex, season, and steps) were stable above 12,000 steps per day. Typically active control steps declined, becoming significantly below intervention participants by month 5 (P = 0.006). Highly active participants at baseline (>14,000 steps per day) in both study groups maintained their activity (P = 0.91). Virtually all (97%) intervention participants were counseled, and the clinic visit duration did not differ by group (P = 0.95). Conclusions Over 6 months, participants receiving a brief, standardized in-clinic activity counseling intervention with on-going kinesiology support were more likely to achieve the recommended daily physical activity. Counseling was feasible for clinicians to deliver during a routine clinic visit enabling compliance with recommended practice. Clinical Trial Registration ClinicalTrials.gov #NCT03435354.