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Clinical Trials/NCT00569478
NCT00569478
Completed
Phase 2

The Effect of Rehabilitation for Patients Living With an ICD

Rigshospitalet, Denmark1 site in 1 country196 target enrollmentOctober 2007
ConditionsQuality of Life

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Quality of Life
Sponsor
Rigshospitalet, Denmark
Enrollment
196
Locations
1
Primary Endpoint
Physical capability
Status
Completed
Last Updated
13 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2007
End Date
October 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Selina Kikkenborg Berg

Ph.D.

Rigshospitalet, Denmark

Eligibility 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.

Outcomes

Primary Outcomes

Physical capability

Time Frame: 3-6-12 month

Quality of life

Time Frame: 3 -6-12 month

Study Sites (1)

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