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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
See description of Arms
Brian W. McCrindle
Toronto, Ontario, Canada
Consent rate
The proportion of participants consented to participate in the study
Time frame: 1 year
Enrolment rate
The proportion of participants who consented and eligible to participate in the study
Time frame: 1 year
Adherence rate
The proportion of participants who adhered to the study intervention based on the number of completed training sessions divided by the total number of training sessions available
Time frame: 1 year
Completion rate
The proportion of participants who completed the study intervention
Time frame: 1 year
Attrition rate
The proportion of participants who withdrew or lost to follow up
Time frame: 1 year
Acceptability questionnaire (Investigator-generated satisfaction questionnaire)
The proportion of participants who were satisfied with the study intervention. An investigator-generated satisfaction questionnaire was created to assess the many components of acceptability of the exercise intervention program. Participants will be provided with statements related to the study intervention, for example "the exercises were enjoyable", and participant will rate these statements based on whether they Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, and Strongly Disagree
Time frame: 1 year
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)
Change in time in oxygen consumption at peak exercise (ml/kg/min). The cardiopulmonary exercise test will be used report objective values for oxygen consumption at peak exercise.
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) (liters))
Change in time in force vital capacity (FVC) (liters)
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 predicted force vital capacity (FVC) (liters))
Change in time in predicted force vital capacity (FVC) (liters)
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 percent predicted force vital capacity (FVC) (%))
Change in time in percent predicted force vital capacity (FVC) (%)
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 forced expiratory volume within one second (FEV1) (L)
Change in time in forced expiratory volume within one second (FEV1) (liters)
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 predicted Forced expiratory volume (FEV1) (L)
Change in time in predicted Forced expiratory volume (FEV1) (liters)
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 percent predicted Forced expiratory volume (FEV1)
Change in time in percent predicted Forced expiratory volume (FEV1) (%)
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 FEV1/FVC (%))
Change in time in FEV1/FVC (%)
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 predicted FEV1/FVC (%))
Change in time in predicted FEV1/FVC (%)
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 maximum voluntary ventilation (MVV) (L/min))
Change in time in maximum voluntary ventilation (MVV) (L/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 predicted Max voluntary ventilation (MVV) (L/min)
Change in time in predicted Maximum voluntary ventilation (MVV) (L/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 % predicted Max voluntary ventilation (MVV)
Change in time in percent predicted Maximum voluntary ventilation (MVV) (%)
Time frame: From baseline to 3 months post intervention
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)
Change in time in grip strength (kg)
Time frame: From baseline to 3 months post intervention
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)
Change in time in flexibility of the lower back and hamstring muscles (cm)
Time frame: From baseline to 3 months post intervention
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)
Change in time in running speed agility (scale score from 1-30, higher score mean better outcome)
Time frame: From baseline to 3 months post intervention
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)
Change in time in muscle strength (scale score from 1-30, higher score mean better outcome)
Time frame: From baseline to 3 months post intervention
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)
Change in participant-reported QoL questionnaire (PedsQL 4.0: Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales). The self-reported QoL questionnaire PedsQL 4.0 is composed of 23 items comprising 4 dimensions. Each item is rated with a 5-point Likert response scale from 0 to 4 (0=never, 1=almost never, 2=sometimes, 3=often, and 4=almost always). Items are reversed scored and linearly transformed to a 0-100 scale. Higher scores indicate better quality of life
Time frame: From baseline to 3 months post intervention
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)
Change in parent-reported QoL questionnaire (PedsQL 4.0: Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales). The parent-reported QoL questionnaire PedsQL 4.0 is composed of 23 items comprising 4 dimensions. Each item is rated with a 5-point Likert response scale from 0 to 4 (0=never, 1=almost never, 2=sometimes, 3=often, and 4=almost always). Items are reversed scored and linearly transformed to a 0-100 scale. Higher scores indicate better quality of life
Time frame: From baseline to 3 months post intervention
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)
Change in participant-reported QoL questionnaire (PedsQLTM 3.0 Cardiac Module). The self-reported PedsQLTM 3.0 Cardiac Module is composed of 23 items comprising 6 dimensions. Each item is rated with a 5-point Likert response scale from 0 to 4 (0=never, 1=almost never, 2=sometimes, 3=often, and 4=almost always). Items are reversed scored and linearly transformed to a 0-100 scale. Higher scores indicate lower problem.
Time frame: From baseline to 3 months post intervention
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)
Change in parent-reported QoL questionnaire (PedsQLTM 3.0 Cardiac Module). The parent-reported PedsQLTM 3.0 Cardiac Module is composed of 23 items comprising 6 dimensions. Each item is rated with a 5-point Likert response scale from 0 to 4 (0=never, 1=almost never, 2=sometimes, 3=often, and 4=almost always). Items are reversed scored and linearly transformed to a 0-100 scale. Higher scores indicate lower problem.
Time frame: From baseline to 3 months post intervention
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)
Change in participant-reported QoL questionnaire (PedsQLTM Multidimensional Fatigue Scale). The self-reported PedsQLTM Multidimensional Fatigue Scale is composed of 18 items comprising 3 dimensions. Each item is rated with a 5-point Likert response scale from 0 to 4 (0=never, 1=almost never, 2=sometimes, 3=often, and 4=almost always). Items are reversed scored and linearly transformed to a 0-100 scale. Higher scores indicate lower problem.
Time frame: From baseline to 3 months post intervention
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)
Change in parent-reported QoL questionnaire (PedsQLTM Multidimensional Fatigue Scale). The parent-reported PedsQLTM Multidimensional Fatigue Scale is composed of 18 items comprising 3 dimensions. Each item is rated with a 5-point Likert response scale from 0 to 4 (0=never, 1=almost never, 2=sometimes, 3=often, and 4=almost always). Items are reversed scored and linearly transformed to a 0-100 scale. Higher scores indicate lower problem.
Time frame: From baseline to 3 months post intervention
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
Change in time in muscle Tissue Saturation Index (TSI) (%)
Time frame: From baseline to 3 months post intervention
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)
Change in time in muscle oxygenation (O2Hb) (%)
Time frame: From baseline to 3 months post intervention
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
Change in time in muscle deoxygenation (HHb) (%)
Time frame: From baseline to 3 months post intervention
The effect of aerobic training only versus combined aerobic and strength training on muscle morphology using ultrasound imaging after Tetralogy of Fallot (TOF) repair
Change in time in quadriceps muscles thickness (cm)
Time frame: From baseline to 3 months post intervention
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))
Change in time in body mass index (kg/m\^2)
Time frame: From baseline to 3 months post intervention
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))
Change in time in waist circumference (cm)
Time frame: From baseline to 3 months post intervention
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))
Change in time in waist/height ratio (WHtR)
Time frame: From baseline to 3 months post intervention
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
Change in time in Children's Self-perceptions of Adequacy and Predilection for Physical Activity (CSAPPA) scale. CSAPPA is a 20-item scale designed to capture children's perceived adequacy to perform physical activities and preference to either physical activity engagement or sedentary pursuit. It is composed of 3 subscales related to physical activity: adequacy (7 items), predilection (9 items), and enjoyment of physical education class (3 items). Each item was structured in an alternative choice format whereby children will be asked to select an option that best describes them. For example, children will choose which of these two statements best identify them "some kids can't wait to play active games after school" or "other kids would rather do something else", then indicate whether the selected claim was either "sort of true for me" or "really true for me". Each response is scored from 1 to 4, where highest score indicate preference to more active endeavours.
Time frame: From baseline to 3 months post intervention
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
Change in time in readiness to change score. the Readiness to Change questionnaire is based on the Transtheoretical Stages of Change Model where an individual's motivation to change behaviour, in the context of exercise/physical activity participation, is classified into 1 of the 5 stages of change which are precontemplation, contemplation, preparation, action, and maintenance.
Time frame: From baseline to 3 months post intervention
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)
Change in time in oxygen consumption at anaerobic exercise (ml/kg/min). The cardiopulmonary exercise test will be used report objective values for oxygen consumption at anaerobic exercise.
Time frame: From baseline to 3 months post intervention
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