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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00569478
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : December 4, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Quality of Life Other: rehabilitation Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Rehabilitation for Patients Living With an ICD
Study Start Date : October 2007
Primary Completion Date : August 2009
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
rehabilitation
Other: rehabilitation
Nursing consultations and physical training
No Intervention: 2
controls


Outcome Measures

Primary Outcome Measures :
  1. Quality of life [ Time Frame: 3 -6-12 month ]
  2. Physical capability [ Time Frame: 3-6-12 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569478


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Novo Nordisk A/S
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