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
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.
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 →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.
Exclusion Criteria:
Standard lifestyle counseling. Short Message Service (SMS) encouragements for physical activity,
Behavioral: eHealth intervention
Standard lifestyle counseling. No Short Message Service (SMS) encouragements for physical activity.
Behavioral: Lifestyle counseling · Behavioral: eHealth intervention
One health conversation at baseline
Also known as: Health conversations with chronically ill adolescents
SMS based encouragements to intensive exercise
Also known as: SMS based encouragements to intensive exercise
Cardiopulmonary exercise capacity
Online V02 max bicycle test
Time frame: 12 months
Level of physical exercise
Actigraph and Questionnaire
Time frame: 12 months
Quality of Life
PedsQl
Time frame: 12 months
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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Rigshospitalet, Denmark