Clinical trial NCT02240147: Start-to-Sport - Home-based Exercise for Adolescents and Adults With Congenital Heart Disease
Official title: Start-to-Sport - Feasibility and Efficacy of Individualized, Telemonitored, Home-based Exercise for Adolescents and Adults With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defect
Keywords: adult congenital heart disease
exercise capacity
exercise training
physical activity
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: peak oxygen uptake
timeFrame: baseline, post-intervention, after 1 year
Secondary outcomes:
measure: physical activity
timeFrame: baseline, post-intervention and after 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: KU Leuven
name: Roselien Buys, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Werner Budts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Budts W, Borjesson M, Chessa M, van Buuren F, Trigo Trindade P, Corrado D, Heidbuchel H, Webb G, Holm J, Papadakis M. Physical activity in adolescents and adults with congenital heart defects: individualized exercise prescription. Eur Heart J. 2013 Dec;34(47):3669-74. doi: 10.1093/eurheartj/eht433. Epub 2013 Nov 7. No abstract available.