S2S-ACHD: Start-to-Sport - Home-based Exercise for Adolescents and Adults With Congenital Heart Disease

Sponsor

KU Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT02240147

Collaborator

(none)

Enrollment

Location

Arms

44.9

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Defect	Behavioral: home-based exercise training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Sep 30, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: home-based exercise training	Behavioral: home-based exercise training During 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.
No Intervention: Control group

Arm

Intervention/Treatment

Experimental: home-based exercise training

Behavioral: home-based exercise training

During 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.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

peak oxygen uptake [baseline, post-intervention, after 1 year]

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.