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

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Quality of Life
 Other: rehabilitation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effect of Rehabilitation for Patients Living With an ICD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ]

Enrollment: 196
Study Start Date: October 2007
Study Completion Date: October 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
rehabilitation
 Other: rehabilitation
Nursing consultations and physical training
No Intervention: 2
controls

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569478

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Novo Nordisk
Investigators
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
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Selina Kikkenborg Berg, Ph.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00569478     History of Changes
Other Study ID Numbers: 1-Berg
Study First Received: December 6, 2007
Last Updated: December 3, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
ICD
Rehabilitation

ClinicalTrials.gov processed this record on May 16, 2013