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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Susanne Hwiid Klausen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01189981
First received: August 25, 2010
Last updated: September 30, 2014
Last verified: September 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Cardiopulmonary exercise capacity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Online V02 max bicycle test


Secondary Outcome Measures:
  • Level of physical exercise [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Actigraph and Questionnaire

  • Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   13 Years to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Susanne Hwiid Klausen, ph.d student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01189981     History of Changes
Other Study ID Numbers: SHK 3341, 959515921
Study First Received: August 25, 2010
Last Updated: September 30, 2014
Health Authority: Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014