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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Internet, Mobil Applications and SMS-based Encouragements to Intensive Exercise in Adolescents With Congenital Heart Disease

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Behavioral: Lifestyle counseling
* Behavioral: eHealth intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eHealth intervention<br>Standard lifestyle counseling. Short Message Service (SMS) encouragements for physical activity, | Behavioral: eHealth intervention<br>* SMS based encouragements to intensive exercise<br>* Other names: SMS based encouragements to intensive exercise;|
| Active Comparator: Lifestyle counseling<br>Standard lifestyle counseling. No Short Message Service (SMS) encouragements for physical activity. | Behavioral: Lifestyle counseling<br>* One health conversation at baseline<br>* Other names: Health conversations with chronically ill adolescents;Behavioral: eHealth intervention<br>* SMS based encouragements to intensive exercise<br>* Other names: SMS based encouragements to intensive exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary exercise capacity | Online V02 max bicycle test | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of physical exercise | Actigraph and Questionnaire | 12 months | 
| Quality of Life | PedsQl | 12 months |