The Effect of Rehabilitation for Patients Living With an Implantable Cardioverter Defibrillator
ICD-rehab
1 other identifier
interventional
196
1 country
1
Brief Summary
The purpose of this study is to describe the effect and meaning of an outpatient-nursing programme including physical activity for patients with implantable cardioverter defibrillators (ICD). Hypothesis: The outpatient nursing programme will increase the perceived health and quality of life; improve the management of life from a patient perspective; reduce fear of exercise and increase physical capability and reduce the number of treatment-demanding arrhythmias.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 quality-of-life
Started Oct 2007
Typical duration for phase_2 quality-of-life
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 6, 2007
CompletedFirst Posted
Study publicly available on registry
December 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedDecember 4, 2012
December 1, 2012
1.8 years
December 6, 2007
December 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Quality of life
3 -6-12 month
Physical capability
3-6-12 month
Study Arms (2)
1
ACTIVE COMPARATORrehabilitation
2
NO INTERVENTIONcontrols
Interventions
Eligibility Criteria
You may qualify if:
- In-patients at Copenhagen University Hospital who just received an ICD for the first time.
You may not qualify if:
- Patients who:
- do not understand the instructions,
- are under 18 years old,
- are diagnosed with a mental disease,
- suffer from a competing disease,
- can not participate in physical training.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Novo Nordisk A/Scollaborator
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (2)
Berg SK, Moons P, Zwisler AD, Winkel P, Pedersen BD, Pedersen PU, Svendsen JH. Phantom shocks in patients with implantable cardioverter defibrillator: results from a randomized rehabilitation trial (COPE-ICD). Europace. 2013 Oct;15(10):1463-7. doi: 10.1093/europace/eut087. Epub 2013 Apr 18.
PMID: 23599170DERIVEDBerg SK, Svendsen JH, Zwisler AD, Pedersen BD, Preisler P, Siersbaek-Hansen L, Hansen MB, Nielsen RH, Pedersen PU. COPE-ICD: a randomised clinical trial studying the effects and meaning of a comprehensive rehabilitation programme for ICD recipients -design, intervention and population. BMC Cardiovasc Disord. 2011 Jun 17;11:33. doi: 10.1186/1471-2261-11-33.
PMID: 21682864DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Selina K Berg, PhD Fellow
Rigshospitalet, Denmark
- PRINCIPAL INVESTIGATOR
Jesper H Svendsen
Rigshospitalet, Denmark
- PRINCIPAL INVESTIGATOR
Preben U Pedersen
Aarhus Universitet
- PRINCIPAL INVESTIGATOR
Birthe D Pedersen
Aarhus Universitet
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D.
Study Record Dates
First Submitted
December 6, 2007
First Posted
December 7, 2007
Study Start
October 1, 2007
Primary Completion
August 1, 2009
Study Completion
October 1, 2011
Last Updated
December 4, 2012
Record last verified: 2012-12