The Effect of Rehabilitation for Patients Living With an Implantable Cardioverter Defibrillator
NCT ID: NCT00569478
Last Updated: 2012-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
196 participants
INTERVENTIONAL
2007-10-31
2011-10-31
Brief Summary
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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.
Detailed Description
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Patients, who receive an ICD are very much protected against SCD and it is assumed that they are less worried and effected by their heart disease than others. That is not correct though. Studies have shown, that living with an ICD can lead to anxiety, fear of shock and avoidance of situations, places and objects that are associated to shock. It often leads to social isolation, avoidance of physical activity and mood-disturbances.
The purpose of this study is to describe the effect and meaning of an outpatient-nursing programme including physical activity for patients with ICD.
Hypothesis: see above
Intervention: The outpatient nursing programme has a duration of 1 year and is directed towards parameters that ICD reportedly affect. The focus is prevention of the known risks and problems. The content is partly information and education in managing an ICD, partly emotional reactions and further discussion of handling life with ICD. 3-month into the program physical training lead by a physical therapist is started. It is optimal whether to carry out the twice-weekly physical training program at home or at the hospital.
180 patients, who get an ICD transplanted at Copenhagen university Hospital, Rigshospitalet, are included in the study prior to discharge. 90 patients in the intervention group and 90 controls.
Using questionnaires, qualitative interviews, work-test, 6 MWT and decoding ICD the effect and meaning of the programme is evaluated.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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1
rehabilitation
rehabilitation
Nursing consultations and physical training
2
controls
No interventions assigned to this group
Interventions
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rehabilitation
Nursing consultations and physical training
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Rigshospitalet, Denmark
OTHER
Responsible Party
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Selina Kikkenborg Berg
Ph.D.
Principal Investigators
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Selina K Berg, PhD Fellow
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Jesper H Svendsen
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Preben U Pedersen
Role: PRINCIPAL_INVESTIGATOR
Aarhus Universitet
Birthe D Pedersen
Role: PRINCIPAL_INVESTIGATOR
Aarhus Universitet
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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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.
Berg 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.
Other Identifiers
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1-Berg
Identifier Type: -
Identifier Source: org_study_id