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

Congenital Heart Defect Clinical Trial

— S2S-ACHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240147
• Other study ID #: S2S-ACHD
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: September 30, 2018

Study information

• Verified date: January 2019
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Defect
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Budts W, Börjesson 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peak oxygen uptake		baseline, post-intervention, after 1 year
Secondary	physical activity	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.	baseline, post-intervention and after 1 year