Exercise Training Strategies for Children With Repaired Tetralogy of Fallot

NCT ID: NCT04208893

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-20
• Study Completion Date: 2022-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Aerobic training only

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.

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

See description of Arms

Combined aerobic and strength training

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.

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

See description of Arms

Interventions

Exercise training

See description of Arms

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Brian McCrindle

Staff Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian McCrindle, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto, Canada

Locations

Brian W. McCrindle

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33112424 (View on PubMed)

Other Identifiers

1000062584

Identifier Type: -

Identifier Source: org_study_id