The Effect of Rehabilitation for Patients Living With an Implantable Cardioverter Defibrillator (ICD-rehab)
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | December 6, 2007 | ||||||||||||||||
| Last Updated Date | December 3, 2012 | ||||||||||||||||
| Start Date ICMJE | October 2007 | ||||||||||||||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00569478 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | The Effect of Rehabilitation for Patients Living With an Implantable Cardioverter Defibrillator | ||||||||||||||||
| Official Title ICMJE | The Effect of Rehabilitation for Patients Living With an ICD | ||||||||||||||||
| 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. |
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| Detailed Description | Implantable cardioverter defibrillators (ICD) are used in the treatment of life-threatening heart arrhythmia and the prevention of sudden cardiac death (SCD). The ICD terminates arrhythmia by delivering therapy in the form of electrical impulses to the heart. Patients have described the high energy shock administered by the devise as feeling like a painful kick in the chest. 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Phase 2 | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Quality of Life | ||||||||||||||||
| Intervention ICMJE | Other: rehabilitation
Nursing consultations and physical training |
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| Study Arm (s) |
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| Publications * | Berg SK, Svendsen JH, Zwisler AD, Pedersen BD, Preisler P, Siersbæk-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. | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | 196 | ||||||||||||||||
| Completion Date | October 2011 | ||||||||||||||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Denmark | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00569478 | ||||||||||||||||
| Other Study ID Numbers ICMJE | 1-Berg | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | Selina Kikkenborg Berg, Rigshospitalet, Denmark | ||||||||||||||||
| Study Sponsor ICMJE | Rigshospitalet, Denmark | ||||||||||||||||
| Collaborators ICMJE | Novo Nordisk | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Rigshospitalet, Denmark | ||||||||||||||||
| Verification Date | December 2012 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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