Clinical Trials Directory

Trials / Completed

CompletedNCT02240147

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

Start-to-Sport - Feasibility and Efficacy of Individualized, Telemonitored, Home-based Exercise for Adolescents and Adults With Congenital Heart Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
KU Leuven · Academic / Other
Sex
All
Age
16 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALhome-based exercise trainingDuring a 30 minute face-to-face motivational interview with an exercise specialist, the patient will be advised and coached about his exercise prescription, on how to implement it in his own daily life and on how to prevent relapse. Furthermore, the patients will receive instructions on how to monitor their exercise intensity and on recognizing adverse signals. During the following 12 weeks, patients will be asked to exercise 4.5 hours per week within the prescribed exercise intensity range according to the guidelines.

Timeline

Start date
2015-01-01
Primary completion
2018-09-30
Completion
2018-09-30
First posted
2014-09-15
Last updated
2019-01-15

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT02240147. Inclusion in this directory is not an endorsement.