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

C

Catholic University (KU) of Leuven

Status

Completed

Conditions

Congenital Heart Defect

Treatments

Behavioral: home-based exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT02240147
S2S-ACHD

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

home-based exercise training
Experimental group
Treatment:
Behavioral: home-based exercise training
Control group
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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