Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-27 @ 11:22 AM
Study NCT ID:
NCT04208893
Status:
SUSPENDED
Last Update Posted:
2021-02-26
First Post:
2019-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Training Strategies for Children With Repaired Tetralogy of Fallot
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
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
Status:
SUSPENDED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study suspended due to COVID-19 restrictions.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: