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

NCT01189981 | Completed Phase 2 DMC

• 2 other identifiers: SHK 3341959515921
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Cardiopulmonary exercise capacity

  Online V02 max bicycle test

  12 months

Secondary Outcomes (2)

• Level of physical exercise

  12 months

• Quality of Life

  12 months

Study Arms (2)

eHealth intervention

EXPERIMENTAL

Standard lifestyle counseling. Short Message Service (SMS) encouragements for physical activity,

Behavioral: eHealth intervention

Lifestyle counseling

ACTIVE COMPARATOR

Standard lifestyle counseling. No Short Message Service (SMS) encouragements for physical activity.

Behavioral: Lifestyle counseling; Behavioral: eHealth intervention

Interventions

Lifestyle counseling BEHAVIORAL

One health conversation at baseline

Also known as: Health conversations with chronically ill adolescents

Lifestyle counseling

eHealth intervention BEHAVIORAL

SMS based encouragements to intensive exercise

Also known as: SMS based encouragements to intensive exercise

Lifestyle counseling; eHealth intervention

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• years of age

You may not qualify if:

• Mental retardation
• Untreated asthma
• Syndromes related to CHD

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

University Hospital Copenhagen

Copenhagen, RegionH, 2100, Denmark

Location

Related Publications (1)

• Klausen SH, Andersen LL, Sondergaard L, Jakobsen JC, Zoffmann V, Dideriksen K, Kruse A, Mikkelsen UR, Wetterslev J. Effects of eHealth physical activity encouragement in adolescents with complex congenital heart disease: The PReVaiL randomized clinical trial. Int J Cardiol. 2016 Oct 15;221:1100-6. doi: 10.1016/j.ijcard.2016.07.092. Epub 2016 Jul 16.

  PMID: 27448540 DERIVED

Related Links

• A detailed statistical analysis plan for the results of the PReVaiL trial

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lars Søndergaard, MD, DMSc

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Susanne Klausen, MSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ph.d student

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 27, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 1, 2014

Record last verified: 2014-09

Locations

DK (1)