NCT02240147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

3.7 years

First QC Date

September 11, 2014

Last Update Submit

January 14, 2019

Conditions

Congenital Heart Defect

Keywords

adult congenital heart diseaseexercise capacityexercise trainingphysical activity

Outcome Measures

Primary Outcomes (1)

  • peak oxygen uptake

    baseline, post-intervention, after 1 year

Secondary Outcomes (1)

  • physical activity

    baseline, post-intervention and after 1 year

Study Arms (2)

home-based exercise training

EXPERIMENTAL
Behavioral: home-based exercise training

Control group

NO INTERVENTION

Interventions

home-based exercise trainingBEHAVIORAL

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.

home-based exercise training

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adolescents and adults with congenital heart disease
  • to 65 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 24204010BACKGROUND

MeSH Terms

Conditions

Heart Defects, CongenitalMotor Activity

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Study Officials

  • Roselien Buys, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

  • Werner Budts, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 15, 2014

Study Start

January 1, 2015

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

BE(1)