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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01189981
First Posted: August 27, 2010
Last Update Posted: October 1, 2014
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.
Information provided by (Responsible Party):
Susanne Hwiid Klausen, Rigshospitalet, Denmark
  Purpose

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.


Condition Intervention Phase
Congenital Heart Disease Behavioral: Lifestyle counseling Behavioral: eHealth intervention Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of Internet, Mobil Applications and SMS-based Encouragements to Intensive Exercise in Adolescents With Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Susanne Hwiid Klausen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Cardiopulmonary exercise capacity [ Time Frame: 12 months ]
    Online V02 max bicycle test


Secondary Outcome Measures:
  • Level of physical exercise [ Time Frame: 12 months ]
    Actigraph and Questionnaire

  • Quality of Life [ Time Frame: 12 months ]
    PedsQl


Enrollment: 158
Study Start Date: October 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eHealth intervention
Standard lifestyle counseling. Short Message Service (SMS) encouragements for physical activity,
Behavioral: eHealth intervention
SMS based encouragements to intensive exercise
Other Name: SMS based encouragements to intensive exercise
Active Comparator: Lifestyle counseling
Standard lifestyle counseling. No Short Message Service (SMS) encouragements for physical activity.
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

  Eligibility

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Ages Eligible for Study:   13 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189981


Locations
Denmark
University Hospital Copenhagen
Copenhagen, RegionH, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Director: Lars Søndergaard, MD, DMSc Rigshospitalet, Denmark
Principal Investigator: Susanne Klausen, MSc Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susanne Hwiid Klausen, ph.d student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01189981     History of Changes
Other Study ID Numbers: SHK 3341
959515921 ( Other Identifier: Rigshospitalet )
First Submitted: August 25, 2010
First Posted: August 27, 2010
Last Update Posted: October 1, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities