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

NCT ID: NCT02240147

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2018-09-30

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.

Conditions

Congenital Heart Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

home-based exercise training

Group Type: EXPERIMENTAL

home-based exercise training

Intervention Type: BEHAVIORAL

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.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Roselien Buys

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roselien Buys, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Werner Budts, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

University Hospitals Leuven

Leuven, , Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 24204010 (View on PubMed)

Other Identifiers

S2S-ACHD

Identifier Type: -

Identifier Source: org_study_id