The Effect of Rehabilitation for Patients Living With an Implantable Cardioverter Defibrillator (ICD-rehab)

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00569478
First received: December 6, 2007
Last updated: December 3, 2012
Last verified: December 2012

December 6, 2007
December 3, 2012
October 2007
August 2009   (final data collection date for primary outcome measure)
  • Quality of life [ Time Frame: 3 -6-12 month ] [ Designated as safety issue: No ]
  • Physical capability [ Time Frame: 3-6-12 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00569478 on ClinicalTrials.gov Archive Site
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The Effect of Rehabilitation for Patients Living With an Implantable Cardioverter Defibrillator
The Effect of Rehabilitation for Patients Living With an ICD

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Quality of Life
Other: rehabilitation
Nursing consultations and physical training
  • Active Comparator: 1
    rehabilitation
    Intervention: Other: rehabilitation
  • No Intervention: 2
    controls

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
196
October 2011
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • In-patients at Copenhagen University Hospital who just received an ICD for the first time.

Exclusion Criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00569478
1-Berg
No
Selina Kikkenborg Berg, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Novo Nordisk A/S
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
Rigshospitalet, Denmark
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP