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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02240147
Recruitment Status : Completed
First Posted : September 15, 2014
Last Update Posted : January 15, 2019
Information provided by (Responsible Party):
Roselien Buys, 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.

Condition or disease Intervention/treatment Phase
Congenital Heart Defect Behavioral: home-based exercise training Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2015
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. peak oxygen uptake [ Time Frame: baseline, post-intervention, after 1 year ]

Secondary Outcome Measures :
  1. physical activity [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02240147

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University Hospitals Leuven
Leuven, Belgium
Sponsors and Collaborators
KU Leuven
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Principal Investigator: Roselien Buys, PhD KU Leuven
Principal Investigator: Werner Budts, PhD KU Leuven

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Responsible Party: Roselien Buys, Dr., KU Leuven Identifier: NCT02240147     History of Changes
Other Study ID Numbers: S2S-ACHD
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

Keywords provided by Roselien Buys, KU Leuven:
adult congenital heart disease
exercise capacity
exercise training
physical activity

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities