Effect of eHealth Encouragements to Intensive Exercise in Adolescents With Congenital Heart Disease (PReVaiL)

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: NCT01189981
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : October 1, 2014
Information provided by (Responsible Party):
Susanne Hwiid Klausen, Rigshospitalet, Denmark

August 25, 2010
August 27, 2010
October 1, 2014
October 2010
May 2014   (Final data collection date for primary outcome measure)
Cardiopulmonary exercise capacity [ Time Frame: 12 months ]
Online V02 max bicycle test
Cardiopulmonary exercise capacity [ Time Frame: 12 months ]
Online V02 max bicycletest
Complete list of historical versions of study NCT01189981 on Archive Site
  • Level of physical exercise [ Time Frame: 12 months ]
    Actigraph and Questionnaire
  • Quality of Life [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
Effect of eHealth Encouragements to Intensive Exercise in Adolescents With Congenital Heart Disease
Effect of Internet, Mobil Applications and SMS-based Encouragements to Intensive Exercise in Adolescents With Congenital Heart Disease

All over the world 0.8 % of all live children are born with a Congenital Heart Disease (CHD) due to genetic end environmental causes. Advanced treatment and care has enhanced survival substantially, and adults with CHD are a growing population requiring continuous monitoring and care. Presently 25% of young adults acquire complicating Cardio Vascular Diseases (CVD) in young adulthood amongst other co-morbidities.

It is known that adolescents with CHD are not as physical fit (PF) as their cardiac capability allows, most likely for reasons concerning safety, ability plus inactive everyday life. However, in 2006 The European Society of Cardiology states, that regular exercise at recommended levels can be performed and should be encouraged in all patients with CHD. Training programmes in hospitals have an effect on PF and Quality of Life (QoL) for the few, as most adolescents' find it impossible to fit into everyday life.

It is the investigators hypothesis that an eHealth intervention, to facilitate intensive exercise in the patients' neighbourhood environs, may improve physical fitness more efficiently than standard lifestyle education.

The purpose of the study is to create evidence to recommend an efficient, fun and safe cardiac rehabilitation programme to adolescents with CHD.

Primary outcome measure

Cardiopulmonary exercise capacity: Online V02 max bicycle test

Secondary outcome measure

Level of physical exercise: Actigraph and Questionnaire

Tertiary outcome measure

Quality of Life: PedsQl

Prevail is a national prospective, randomized clinical trial including 216 adolescents aged 13-16 years, who have had cardiac surgery in childhood owing to complex CHD. The patients included are all recommended to be as physical active as their healthy peers and pursue the principle guideline from The National Board of Health: "All children and young people must be physically active for at least 60 minutes a day, preferably longer". Patients with mental retardation and FEV1 at baseline < 80% of predicted are excluded.

The risk of participating in the purposed trial is not regarded as higher than everyday daily living.

Results will be interpreted according to affiliation to health related fitness clusters.

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Congenital Heart Disease
  • Behavioral: Lifestyle counseling
    One health conversation at baseline
    Other Name: Health conversations with chronically ill adolescents
  • Behavioral: eHealth intervention
    SMS based encouragements to intensive exercise
    Other Name: SMS based encouragements to intensive exercise
  • Experimental: eHealth intervention
    Standard lifestyle counseling. Short Message Service (SMS) encouragements for physical activity,
    Intervention: Behavioral: eHealth intervention
  • Active Comparator: Lifestyle counseling
    Standard lifestyle counseling. No Short Message Service (SMS) encouragements for physical activity.
    • Behavioral: Lifestyle counseling
    • Behavioral: eHealth intervention
Klausen SH, Andersen LL, Søndergaard L, Jakobsen JC, Zoffmann V, Dideriksen K, Kruse A, Mikkelsen UR, Wetterslev J. Effects of eHealth physical activity encouragement in adolescents with complex congenital heart disease: The PReVaiL randomized clinical trial. Int J Cardiol. 2016 Oct 15;221:1100-6. doi: 10.1016/j.ijcard.2016.07.092. Epub 2016 Jul 16.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2014
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Congenital heart disease with allowance for unrestricted exercise
  • Diagnosis: Q20.0 Truncus arteriosus communis, Q20.1 Transpositio vasorum incompleta, Q20.3 Transpositio vasorum completa, Q20.5 Inversio ventriculorum cordis, Q21.2 Defectus septi atrioventriculorum cordis, Q21.3 Tetralogia Steno-Fallot, Q22.4 Tricusspidalatresia , Q22.5 Anomalia Ebstein, Q23.2 Mitralatresia, Double outlet right ventricle, Q23.3 Hypoplasia ventriculi sinistri cordis syndrome, Q23.3 Hypoplasia ventriculi dextrii cordis syndrome, Q24.4 Stenosis subaortae congenita, Q25.1 Coarctatio aortae, Q25.1 Coarctatio Aortae, Double inlet left ventricle, Q25.3 Stenosis aortae supravalvularis, Q25.5 Pulmonalatresia.
  • Successful Total Cavo Pulmonal Connex (TCPC procedure)
  • 13- 16 years of age

Exclusion Criteria:

  • Mental retardation
  • Untreated asthma
  • Syndromes related to CHD
Sexes Eligible for Study: All
13 Years to 16 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
SHK 3341
959515921 ( Other Identifier: Rigshospitalet )
Not Provided
Not Provided
Susanne Hwiid Klausen, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Study Director: Lars Søndergaard, MD, DMSc Rigshospitalet, Denmark
Principal Investigator: Susanne Klausen, MSc Rigshospitalet, Denmark
Rigshospitalet, Denmark
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP