Tetralogy of FallotNCT04208893
Exercise Training Strategies for Children With Repaired Tetralogy of Fallot
A study testing Exercise training in people with Tetralogy of Fallot and Congenital Heart Defects, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Tetralogy of Fallot, Congenital Heart Defects, Congenital Abnormalities
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Tetralogy of Fallot, Congenital Heart Defects, Congenital Abnormalities, Cardiovascular Diseases, Heart Diseases
- Being tested
- Exercise training
- Keywords
- Pediatrics, Tetralogy of Fallot, Exercise intervention, Physical fitness, Congenital Heart Defects, Exercise rehabilitation
- Medical subject headings
- Tetralogy of Fallot, Heart Defects, Congenital, Congenital Abnormalities, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
See description of Arms
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training only | Experimental | The aerobic training intervention will include 60 minutes/session, 3 times/week for 12 weeks at an intensity of 65% - 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 10-minute of 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. Receives: Behavioral: Exercise training |
| Combined aerobic and strength training | Experimental | Participants in this group will perform a combination of aerobic and strength training activities for 60 minutes/session, 3 times/week for 12 weeks. Aerobic activities for this group will be similar to Arm 1. Strength training will be based on participant's individual assessment findings and developmental status. Resistance level will be set at approximately 50% of the patient maximal load and increased by 3 pounds (or the next level of resistance band) once the patient is able to perform 30 repetitions. Closed kinetic chain exercises such as pushups, squats, and lunges will be made more challenging by the addition of weight or change in body position. Training sessions will include a 10-minute warm up, 40-minute aerobic and strength exercises, and a 10-minute cooldown. Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate
The proportion of participants consented to participate in the study
Measured: 1 year
Enrolment rate
The proportion of participants who consented and eligible to participate in the study
Measured: 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
Measured: 1 year
Completion rate
The proportion of participants who completed the study intervention
Measured: 1 year
Attrition rate
The proportion of participants who withdrew or lost to follow up
Measured: 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
Measured: 1 year
Secondary outcomes (32)
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.
Measured: 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)
Measured: 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)
Measured: 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) (%)
Measured: 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)
Measured: 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)
Measured: 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) (%)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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)
Measured: 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)
Measured: 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) (%)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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) (%)
Measured: 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) (%)
Measured: 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) (%)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start20 Aug 2019
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2022 (estimated)
Why it stopped: Study suspended due to COVID-19 restrictions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian McCrindle, The Hospital for Sick Children
- Investigators
- Brian McCrindle, MD, Principal investigator, The Hospital for Sick Children, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208893
- Sponsor's protocol ID
- 1000062584
- Status last verified
- Feb 2021
- First submitted
- 8 Nov 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33112424
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04208893
- Acronym / sponsor ID
- 1000062584
- 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
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study suspended due to COVID-19 restrictions.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic training only | Experimental | Behavioral: Exercise trainingThe aerobic training intervention will include 60 minutes/session, 3 times/week for 12 weeks at an intensity of 65% - 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 10-minute of 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. |
| Combined aerobic and strength training | Experimental | Behavioral: Exercise trainingParticipants in this group will perform a combination of aerobic and strength training activities for 60 minutes/session, 3 times/week for 12 weeks. Aerobic activities for this group will be similar to Arm 1. Strength training will be based on participant's individual assessment findings and developmental status. Resistance level will be set at approximately 50% of the patient maximal load and increased by 3 pounds (or the next level of resistance band) once the patient is able to perform 30 repetitions. Closed kinetic chain exercises such as pushups, squats, and lunges will be made more challenging by the addition of weight or change in body position. Training sessions will include a 10-minute warm up, 40-minute aerobic and strength exercises, and a 10-minute cooldown. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingSee description of Arms | Behavioural | Aerobic training only, Combined aerobic and strength training |
Primary outcome
Consent rate
Time frame: 1 year
The proportion of participants consented to participate in the study
Enrolment rate
Time frame: 1 year
The proportion of participants who consented and eligible to participate in the study
Adherence rate
Time frame: 1 year
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
Completion rate
Time frame: 1 year
The proportion of participants who completed the study intervention
Attrition rate
Time frame: 1 year
The proportion of participants who withdrew or lost to follow up
Acceptability questionnaire (Investigator-generated satisfaction questionnaire)
Time frame: 1 year
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
32 secondary outcomes
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)
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))
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))
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) (%))
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)
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)
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)
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 (%))
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 (%))
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))
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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)
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
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
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))
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))
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))
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
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
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)
Time frame: From baseline to 3 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Derived from this study: PubMed 33112424Williams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian McCrindle, MD principal investigator
The Hospital for Sick Children, Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Tetralogy of Fallot and Congenital Heart Defects, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rate (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04208893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.