NCT04208893.

Study name	Exercise training strategies for children with repaired tetralogy of Fallot
Methods	RCT
Participants	Paediatrics with repaired tetralogy of Fallot
Interventions	The aerobic training intervention will include 60 minutes/session, 3 times/week for 12 weeks at an intensity of 65% to 85% of participants' heart rate reserve (HRR), as determined by the CPET. Patients will be asked to wear a fitness‐tracking device to monitor their heart rate response and in order to comply with the prescribed training intensity. All training sessions will start with a 10‐minute warm up, 40‐minute aerobic interventions, and ends with a 10‐minutes cool down. One study doctor will be on call during in‐hospital training. Onsite supervised aerobic interventions will include play‐based activities, whereas home‐based aerobic activities will include stationary bikes and exercise activities that would target desired heart rate ranges. Home exercise equipment will be provided.
Outcomes	Primary Consent rate (time frame: 1 year) Enrolment rate (time frame: 1 year) Adherence rate (time frame: 1 year) Completion rate (time frame: 1 year) Attrition rate (time frame: 1 year) Acceptability questionnaire Secondary The effect of aerobic training only versus combined aerobic and strength training on exercise capacity using cardiopulmonary exercise test in children with repaired tetralogy of Fallot (ToF) (peak exercise ml/kg/min) (time frame: from baseline to 3 months post intervention) The effect of aerobic training only versus combined aerobic and strength training on pulmonary measures using pulmonary function test in children with repaired tetralogy of Fallot (ToF) (Change in time in force vital capacity (FVC) (litres)) (time frame: from baseline to 3 months post intervention).  Many others planned outcomes see registry
Starting date	2019
Contact information	Brian McCrindle, MDThe Hospital for Sick Children, Toronto, Canada
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