Quality of LifePhase 2ICD-rehabNCT00569478
The Effect of Rehabilitation for Patients Living With an Implantable Cardioverter Defibrillator
A Phase 2 study testing rehabilitation in people with Quality of Life, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2007to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In-patients at Copenhagen University Hospital who just received an ICD for the first time.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- rehabilitation
- Keywords
- ICD, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitationOther
Nursing consultations and physical training
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | rehabilitation Receives: Other: rehabilitation |
| 2 | No intervention | controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: 3 -6-12 month
Physical capability
Measured: 3-6-12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2009
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Selina Kikkenborg Berg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Selina K Berg, PhD Fellow, Principal investigator, Copenhagen University Hospital, RigshospitaletJesper H Svendsen, Principal investigator, Copenhagen University Hospital, RigshospitaletPreben U Pedersen, Principal investigator, Aarhus UniversitetBirthe D Pedersen, Principal investigator, Aarhus Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569478
- Sponsor's protocol ID
- 1-Berg
- Acronym
- ICD-rehab
- Status last verified
- Dec 2012
- First submitted
- 6 Dec 2007
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Berg SK, Moons P, Zwisler AD, Winkel P, Pedersen BD, Pedersen PU, Svendsen JH. Phantom shocks in patients with implantable cardioverter defibrillator: results from a randomized rehabilitation trial (COPE-ICD). Europace. 2013 Oct;15(10):1463-7. doi: 10.1093/europace/eut087. Epub 2013 Apr 18.
PubMed 23599170Berg SK, Svendsen JH, Zwisler AD, Pedersen BD, Preisler P, Siersbaek-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. doi: 10.1186/1471-2261-11-33.
PubMed 21682864
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rehabilitation for Patients Living With an ICD
- ClinicalTrials.gov ID
- NCT00569478
- Acronym / sponsor ID
- ICD-rehab / 1-Berg
- Conditions
- Quality of Life
- Keywords
- ICD, Rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Oct 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 7 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: rehabilitationrehabilitation |
| 2 | No intervention | –controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In-patients at Copenhagen University Hospital who just received an ICD for the first time.
Key exclusion criteria (6 listed)
- Patients who:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rehabilitationNursing consultations and physical training | Other | 1 |
Primary outcome
Quality of life
Time frame: 3 -6-12 month
Physical capability
Time frame: 3-6-12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Derived from this study: PubMed 23599170Berg SK, Moons P, Zwisler AD, Winkel P, Pedersen BD, Pedersen PU, Svendsen JH. Phantom shocks in patients with implantable cardioverter defibrillator: results from a randomized rehabilitation trial (COPE-ICD). Europace. 2013 Oct;15(10):1463-7. doi: 10.1093/europace/eut087. Epub 2013 Apr 18.
- Derived from this study: PubMed 21682864Berg SK, Svendsen JH, Zwisler AD, Pedersen BD, Preisler P, Siersbaek-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. doi: 10.1186/1471-2261-11-33.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selina K Berg, PhD Fellow principal investigator
Copenhagen University Hospital, Rigshospitalet
Jesper H Svendsen principal investigator
Copenhagen University Hospital, Rigshospitalet
Preben U Pedersen principal investigator
Aarhus Universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rehabilitation in people with Quality of Life, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 3 -6-12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00569478, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.