The Effect of Exercise Prescription and Delivery in Congenital Heart Disease – The Congenital Heart Fitness Intervention Trial: CH-FIT

Not Applicable

• Conditions: Congenital Heart Disease; Fontan circulation; Hypoplastic Left Heart Syndrome; Tricuspid Atresia; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Tetralogy of Fallot; Transposition of the Great Arteries; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12622000050752
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-17
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

Aged 10 to 55 years
-People with congenital heart disease of moderate or great complexity
-At least 6 months post surgical repair
-Medically stable and on stable therapy for at least 3 months

Exclusion Criteria

-Physiological stage D
-Planned intervention within 2 years
-Mental or physical disability that prevents participation in exercise training
-Current or actively planned pregnancy within one year
-Uncontrolled (systemic) hypertension at rest of exercise
-Clinically unstable or recent major change in therapy within 3 months
-COVID-19 unvaccinated people despite being eligible according to ATAGI
-People with unreliable internet connection
-People currently participating in more than 30 minutes of sports or exercise training three times a week

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in peak oxygen uptake assessed by cardiopulmonary exercise testing[Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).]