Effect of eHealth Encouragements to Intensive Exercise in Adolescents With Congenital Heart Disease
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): Lifestyle counseling; eHealth intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): One health conversation at baseline; SMS based encouragements to intensive exercise
Other intervention name(s): Health conversations with chronically ill adolescents; SMS based encouragements to intensive exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research