Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Consent rate |
The proportion of participants consented to participate in the study |
1 year |
|
| Primary |
Enrolment rate |
The proportion of participants who consented and eligible to participate in the study |
1 year |
|
| Primary |
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 |
1 year |
|
| Primary |
Completion rate |
The proportion of participants who completed the study intervention |
1 year |
|
| Primary |
Attrition rate |
The proportion of participants who withdrew or lost to follow up |
1 year |
|
| Primary |
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 |
1 year |
|
| Secondary |
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. |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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) (%) |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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) (%) |
From baseline to 3 months post intervention |
|
| Secondary |
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 (%) |
From baseline to 3 months post intervention |
|
| Secondary |
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 (%) |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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) (%) |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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 |
From baseline to 3 months post intervention |
|
| Secondary |
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 |
From baseline to 3 months post intervention |
|
| Secondary |
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. |
From baseline to 3 months post intervention |
|
| Secondary |
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. |
From baseline to 3 months post intervention |
|
| Secondary |
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. |
From baseline to 3 months post intervention |
|
| Secondary |
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. |
From baseline to 3 months post intervention |
|
| Secondary |
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) (%) |
From baseline to 3 months post intervention |
|
| Secondary |
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) (%) |
From baseline to 3 months post intervention |
|
| Secondary |
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) (%) |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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) |
From baseline to 3 months post intervention |
|
| Secondary |
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. |
From baseline to 3 months post intervention |
|
| Secondary |
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. |
From baseline to 3 months post intervention |
|
| Secondary |
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. |
From baseline to 3 months post intervention |
|
