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CompletedNCT01189981PReVaiLUpdated Oct 1, 2014

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

A Phase 2 interventional study of Lifestyle counseling and eHealth intervention in Congenital Heart Disease, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 13 Years to 16 Years. Per ClinicalTrials.gov, last updated 2014-10-01.

Sponsored by Rigshospitalet, Denmark · Phase 2, Interventional, and Health services research

Phase
Phase 2
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
13 Years to 16 Years
Sex
All
01

Study summary

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.

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Conditions studied

  • Congenital Heart Disease
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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 158 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Mental retardation
  • Untreated asthma
  • Syndromes related to CHD
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Study design

Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
158 participants (actual)

Study arms

  • Experimental
    eHealth intervention

    Standard lifestyle counseling. Short Message Service (SMS) encouragements for physical activity,

    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

Interventions

  • BehavioralLifestyle counseling

    One health conversation at baseline

    Also known as: Health conversations with chronically ill adolescents

  • BehavioraleHealth intervention

    SMS based encouragements to intensive exercise

    Also known as: SMS based encouragements to intensive exercise

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What researchers measure

Primary outcomes

  1. Cardiopulmonary exercise capacity

    Online V02 max bicycle test

    Time frame: 12 months

Secondary outcomes

  1. Level of physical exercise

    Actigraph and Questionnaire

    Time frame: 12 months

  2. Quality of Life

    PedsQl

    Time frame: 12 months

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Study locations

1 site
  • University Hospital Copenhagen
    Copenhagen, RegionH 2100, Denmark
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References and documents

Publications

  • Klausen SH, Andersen LL, Sondergaard 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. PubMed 27448540 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01189981
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Susanne Hwiid Klausen (ph.d student, Rigshospitalet, Denmark) — Principal investigator
First posted
Aug 27, 2010
Start date
Oct 2010
Primary completion
May 2014
Completion
May 2014
Last update
Oct 1, 2014

Study contacts

Lars Søndergaard, MD, DMSc
study director · Rigshospitalet, Denmark
Susanne Klausen, MSc
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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