Exercise Training Strategies for Children With Repaired Tetralogy of Fallot

NCT04208893 | Suspended

• 1 other identifier: 1000062584
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• Consent rate

  The proportion of participants consented to participate in the study

  1 year

• Enrolment rate

  The proportion of participants who consented and eligible to participate in the study

  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

  1 year

• Completion rate

  The proportion of participants who completed the study intervention

  1 year

• Attrition rate

  The proportion of participants who withdrew or lost to follow up

  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

  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)

  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))

  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))

  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) (%))

  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)

  From baseline to 3 months post intervention

Study Arms (2)

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.

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.

Behavioral: Exercise training

Interventions

Exercise training BEHAVIORAL

See description of Arms

Aerobic training only; Combined aerobic and strength training

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Brian W. McCrindle

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 33112424 DERIVED

MeSH Terms

Conditions

Tetralogy of Fallot; Heart Defects, Congenital; Congenital Abnormalities; Cardiovascular Diseases; Heart Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Brian McCrindle, MD

  The Hospital for Sick Children, Toronto, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: December 23, 2019
• Study Start: August 20, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2022
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

CA (1)