Clinical trial NCT04208893: Exercise Training Strategies for Children With Repaired Tetralogy of Fallot
Official title: Combined Facility and Home-based Exercise Intervention of Supervised Aerobic Versus Combined Aerobic and Strength Training in Children With Repaired Tetralogy of Fallot: A Feasibility Pilot Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Tetralogy of Fallot
Congenital Heart Defects
Congenital Abnormalities
Cardiovascular Diseases
Heart Diseases
Keywords: Pediatrics
Tetralogy of Fallot
Exercise intervention
Physical fitness
Congenital Heart Defects
Exercise rehabilitation
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators will explore the feasibility and safety of two exercise interventions delivered both in the hospital and in participants' homes. Preteens and adolescents who have had repaired Tetralogy of Fallot (TOF), will be grouped by age and randomly assigned to either an aerobic or strength training exercise program supervised for 12 weeks. An exploratory aim of this study will be to examine changes in fitness level, muscle strength, muscle oxygen extraction and quality of life after the intervention, and compare these measures between groups. At the end of the study, participants and parents will be interviewed to assess their satisfaction and ideas for improvements in the program.

Detailed description: While adult cardiac rehabilitation (CR) is an established clinical practice, the conceptualization, design and utility of pediatric CR programs have been poorly studied. Particular challenges for children with heart disease include uncertainties regarding physical activity restrictions imposed by clinicians and overprotection by caregivers. These challenges may lead to poor lifestyle and deconditioning, resulting in increased health risks associated with inactivity, such as adiposity, and reduced perceived general health and quality of life. Preliminary studies have shown therapeutic benefits of physical exercise as an add-on therapy in an effort to improve patients' functional outcome after cardiac surgery 1; however, delivery of these programs has been variable, and it is not clear whether a combined program of facility and home-based exercise would yield higher patient adherence for children. The investigators hypothesize that a supervised exercise training program delivered both in the hospital and in participants' homes will be acceptable and feasible for children with repaired Tetralogy of Fallot (TOF). The investigators will conduct a pilot trial over 1 year in which the investigators will randomize 20 participants to either aerobic exercise only or a combined aerobic and strength training program for 12 weeks. The investigators will conduct qualitative interviews to understand intervention acceptability. Results will support a larger definitive study aimed at determining efficacy.

Eligibility criteria: Inclusion Criteria:

* Boys and girls ages 10 to 17 years with repaired Tetralogy of Fallot, currently followed at The Hospital for Sick Children, Toronto, Ontario
* Participant fluent in English

Exclusion Criteria:

* Moderate-to-severe ventricular dysfunction at the latest echocardiogram (defined as the qualitative grade given on the echocardiogram done closest to the intervention)
* Previous history of or documented frequent premature atrial or ventricular contractions or runs or associated tachycardia at the latest exercise test
* Reside outside 50km radius from SickKids or \>1hour travel distance to SickKids
* Lack of internet and computer/laptop access
* Skeletal muscle or orthopedic pathologies
* Neurodevelopmental delay that would preclude participation in an exercise program
* History of syncope with exercise
* Planned surgery requiring admission to intensive care unit during the study intervention

Primary outcomes:
measure: Consent rate
timeFrame: 1 year
measure: Enrolment rate
timeFrame: 1 year
measure: Adherence rate
timeFrame: 1 year
measure: Completion rate
timeFrame: 1 year
measure: Attrition rate
timeFrame: 1 year
measure: Acceptability questionnaire (Investigator-generated satisfaction questionnaire)
timeFrame: 1 year
Secondary outcomes:
measure: 7. 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)
timeFrame: From baseline to 3 months post intervention
measure: 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) (liters))
timeFrame: From baseline to 3 months post intervention
measure: 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 predicted force vital capacity (FVC) (liters))
timeFrame: From baseline to 3 months post intervention
measure: 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 percent predicted force vital capacity (FVC) (%))
timeFrame: From baseline to 3 months post intervention
measure: 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 forced expiratory volume within one second (FEV1) (L)
timeFrame: From baseline to 3 months post intervention
measure: 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 predicted Forced expiratory volume (FEV1) (L)
timeFrame: From baseline to 3 months post intervention
measure: 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 percent predicted Forced expiratory volume (FEV1)
timeFrame: From baseline to 3 months post intervention
measure: 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 FEV1/FVC (%))
timeFrame: From baseline to 3 months post intervention
measure: 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 predicted FEV1/FVC (%))
timeFrame: From baseline to 3 months post intervention
measure: 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 maximum voluntary ventilation (MVV) (L/min))
timeFrame: From baseline to 3 months post intervention
measure: 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 predicted Max voluntary ventilation (MVV) (L/min)
timeFrame: From baseline to 3 months post intervention
measure: 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 % predicted Max voluntary ventilation (MVV)
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on muscle strength using a handheld dynamometer (JAMAR) in children with repaired Tetralogy of Fallot (TOF)
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on flexibility using the sit-and-reach test in children with repaired Tetralogy of Fallot (TOF)
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on muscle strength using the Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2) in children with repaired Tetralogy of Fallot (TOF)
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on running speed and agility using the Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2) in children with repaired Tetralogy of Fallot (TOF)
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on participant-reported quality of life (QoL) questionnaire score in children with repaired Tetralogy of Fallot (TOF)
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on parent-reported quality of life (QoL) questionnaire score in children with repaired Tetralogy of Fallot (TOF)
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on participant-reported quality of life (QoL) questionnaire score (PedsQLTM 3.0 Cardiac Module) in children with repaired Tetralogy of Fallot (TOF)
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on parent-reported quality of life (QoL) questionnaire score (PedsQLTM 3.0 Cardiac Module) in children with repaired Tetralogy of Fallot (TOF)
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on participant-reported quality of life (QoL) questionnaire score (PedsQLTM Multidimensional Fatigue Scale) in children with repaired Tetralogy of Fallot (TOF)
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on parent-reported quality of life (QoL) questionnaire score (PedsQLTM Multidimensional Fatigue Scale) in children with repaired Tetralogy of Fallot (TOF)
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on muscle Tissue Saturation Index (TSI) using near-infrared spectroscopy device after Tetralogy of Fallot (TOF) repair
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on muscle oxygenation using near-infrared spectroscopy device after Tetralogy of Fallot (TOF)
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on muscle deoxygenation using near-infrared spectroscopy device after Tetralogy of Fallot (TOF) repair
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on muscle morphology using ultrasound imaging after Tetralogy of Fallot (TOF) repair
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on anthropometric measures in children with repaired Tetralogy of Fallot (TOF) (Change in time in body mass index (kg/m^2))
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on anthropometric measures in children with repaired Tetralogy of Fallot (TOF) (Change in time in waist circumference (cm))
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on anthropometric measures in children with repaired Tetralogy of Fallot (TOF) (Change in time in waist/height ratio (WHtR))
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on self-efficacy participation to physical activity after Tetralogy of Fallot (TOF) repair
timeFrame: From baseline to 3 months post intervention
measure: The effect of aerobic training only versus combined aerobic and strength training on participant's readiness to change behaviour after Tetralogy of Fallot (TOF) repair
timeFrame: From baseline to 3 months post intervention
measure: 8. 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) (anerobic exercise ml/kg/min)
timeFrame: From baseline to 3 months post intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Brian W. McCrindle
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto, Canada
name: Brian McCrindle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams CA, Wadey C, Pieles G, Stuart G, Taylor RS, Long L. Physical activity interventions for people with congenital heart disease. Cochrane Database Syst Rev. 2020 Oct 28;10(10):CD013400. doi: 10.1002/14651858.CD013400.pub2.