Start-to-Sport - Home-based Exercise for Adolescents and Adults With Congenital Heart Disease

Not Applicable

Completed

• Conditions: Congenital Heart Defect
• Interventions: Behavioral: home-based exercise training

• Registration Number: NCT02240147
• Lead Sponsor: KU Leuven

Brief Summary

Almost 1% of all baby's is born with a heart defect (CHD) and most of them survive. Even though outcomes are good, they need lifelong follow-up because of a higher risk for cardiovascular diseases. Studies have shown that patients with CHD are not active enough and that a substantial amount of patients is overweight. Hence preventive strategies and education should not only focus on the heart problem, but also on a healthy lifestyle including physical activity. Recently a new guideline introduced exercise prescription based on the absence/presence of certain key elements. However, a number of important questions remain that preclude implementation in clinical practice. Therefore a 'Start-to-Sport' program for adults with CHD, based on this new guideline, will be investigated. This study is a randomized controlled trial that investigates the effects of the program on daily physical activity, exercise capacity, quality of life and exercise self-efficacy both in short (12 weeks) and long (52 weeks) term, along with possible mechanisms for the training effects by using a new exercise-testing protocol that looks simultaneously to all body parts that are involved during exercise. Ultimately, our findings will result in the implementation of the guideline in clinical practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-15
• Study Start: 2015-01-01
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• adolescents and adults with congenital heart disease
• 16 to 65 years

Exclusion Criteria

• congenital rhythm or conduction disorders
• isolated congenital coronary artery anomalies
• pregnancy
• being listed for heart transplantation
• inability to perform standard physical activities due to mental/physical disability.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
home-based exercise training	home-based exercise training	-

Primary Outcome Measures

Name	Time	Method
peak oxygen uptake	baseline, post-intervention, after 1 year

Secondary Outcome Measures

Name	Time	Method
physical activity	baseline, post-intervention and after 1 year	Physical activity will be assessed by means of the Sensewear mini armband. The patient will be asked to wear the device day and night during 1 week, while also taking notes of the physical activities undertaken by means of a logbook.

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium