Heart Valve DiseasePhase 2CopenHeartVRNCT01558765
CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery
A Phase 2 study testing Integrated rehabilitation in people with Heart Valve Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the effect of an integrated rehabilitation programme, consisting of physical exercise training and psycho-educational consultations, for patients after heart valve surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Valve Disease
- What is being tested?
- Integrated rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to May 2015
- 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
- Admitted to hospital for elective heart valve surgery at Rigshospitalet, Denmark
- 18 years or older
- Speak and understand Danish
- Providing written informed consent
Who cannot join
- Known ischemic heart disease prior to heart valve surgery
- Is included in an other clinical trial investigating the effects of physical training and psycho-educational intervention
- Unable to understand and cooperate to study instructions
- Pregnant and/or breast feeding
- Performing exercise training at high level and several times a week
- No written informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet / Copenhagen University Hospital
Copenhagen, Copenhagen, 2100
About this study
Official title: CopenHeartVR - A Randomized Clinical Trial Investigating the Effect of Integrated Rehabilitation Versus Usual Care Without Physical Exercise After Heart Valve Surgery.
The aim of the study is to investigate the effect of an integrated rehabilitation programme, consisting of physical exercise training and psycho-educational consultations, for patients after heart valve surgery.
The hypothesis is that integrated rehabilitation can improve physical capacity measured by V02 peak, self-rated mental health and life quality by validated questionnaires such as SF-36, and other objective parameters such as cardiac-specific biomarkers and echocardiographic measurements.
Read the detailed description
Worldwide, the incidence of heart valve disease is increasing. Improved surgical techniques, rising age and possibility for re-operation leads to a rising number of patients having heart valve surgery. The gap between hospital discharge and returning to normal life is obvious. Integrated rehabilitation could probably reduce hospital readmissions, increase physical capacity and increase self-rated mental health and quality of life. Therefore the aim of this study is to explore if patients after heart valve surgery will benefit from an integrated rehabilitation programme consisting of physical exercise and psycho-educational intervention.
A randomized clinical trial is conducted to investigate the effect and meaning of an integrated rehabilitation programme on the physical and psychosocial functioning of patients after heart valve surgery. The trial is a parallel arm design.
A mixed methods embedded experimental design is chosen to include both quantitative and qualitative data to evaluate the intervention. The intervention consists of five psycho-educational consultations provided by specialized nurses and a twelve week individualized exercise training programme provided by physiotherapists. A qualitative post-intervention study will explore rehabilitation participation experiences.
Along with the above stated hypothesis, it will be observed whether integrated rehabilitation can reduce anxiety, depression, health care utilisation, mortality and work cessation.
210 patients will be included.
Validated questionnaires (e.g. SF-36), cardiopulmonary exercise testing, 6 minute walking test, echocardiography, cardiac-specific biomarkers and qualitative interviews will be used to evaluate the effect and meaning of the programme.
- Conditions
- Heart Valve Disease
- Being tested
- Integrated rehabilitation
- Keywords
- Rehabilitation, Integrated rehabilitation programme, Exercise training, Psycho-educational care
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated rehabilitationOther
Integrated rehabilitation consisting of exercise training (3 times per week (1 hour) for 12 weeks) and psycho-educational care (5 consultations over 6 months by special trained nurses).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients receive integrated rehabilitation Receives: Other: Integrated rehabilitation |
| Control group | No intervention | Patients receive usual follow-up care without physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical capacity
Measured by Vo2peak by ergospirometry testing
Measured: 1,4,12 months
Secondary outcomes (1)
Change in self-rated mental health and quality of life
Measured by total score and the mental health component scale (MSC) in the SF-36 questionnaire.
Measured: 0, 1, 4, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selina Kikkenborg Berg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kirstine Laerum Sibilitz, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletAnn-Dorthe Zwisler, MD, Ph.d., Principal investigator, Rigshospitalet / Copenhagen University Hospital, National Institute of Public Health, University of Southern DenmarkSelina Kikkenborg Berg, Ph.d., Principal investigator, Copenhagen University Hospital, RigshospitaletChristian Hassager, MD, DMSc, Principal investigator, Copenhagen University Hospital, RigshospitaletLars Køber, MD, DMSc, Principal investigator, Copenhagen University Hospital, RigshospitaletDaniel Steinbrüchel, MD, DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558765
- Sponsor's protocol ID
- RHCopenHeartVR
- Acronym
- CopenHeartVR
- Status last verified
- Nov 2015
- First submitted
- 16 Mar 2012
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sibilitz KL, Berg SK, Rasmussen TB, Risom SS, Thygesen LC, Tang L, Hansen TB, Johansen PP, Gluud C, Lindschou J, Schmid JP, Hassager C, Kober L, Taylor RS, Zwisler AD. Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial. Heart. 2016 Dec 15;102(24):1995-2003. doi: 10.1136/heartjnl-2016-309414. Epub 2016 Aug 4.
PubMed 27492941Sibilitz KL, Berg SK, Hansen TB, Risom SS, Rasmussen TB, Hassager C, Kober L, Gluud C, Thygesen LC, Lindschou J, Schmid JP, Taylor RS, Zwisler AD. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control: the CopenHeartVR trial. Trials. 2015 Feb 5;16:38. doi: 10.1186/s13063-015-0562-z.
PubMed 25887433Sibilitz KL, Berg SK, Hansen TB, Risom SS, Rasmussen TB, Hassager C, Kober L, Steinbruchel D, Gluud C, Winkel P, Thygesen LC, Hansen JL, Schmid JP, Conraads V, Brocki BC, Zwisler AD. Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial. Trials. 2013 Apr 22;14:104. doi: 10.1186/1745-6215-14-104.
PubMed 23782510
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CopenHeartVR - A Randomized Clinical Trial Investigating the Effect of Integrated Rehabilitation Versus Usual Care Without Physical Exercise After Heart Valve Surgery.
- ClinicalTrials.gov ID
- NCT01558765
- Acronym / sponsor ID
- CopenHeartVR / RHCopenHeartVR
- Conditions
- Heart Valve Disease
- Keywords
- Rehabilitation, Integrated rehabilitation programme, Exercise training, Psycho-educational care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Mar 2012 (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 aim of the study is to investigate the effect of an integrated rehabilitation programme, consisting of physical exercise training and psycho-educational consultations, for patients after heart valve surgery.
The hypothesis is that integrated rehabilitation can improve physical capacity measured by V02 peak, self-rated mental health and life quality by validated questionnaires such as SF-36, and other objective parameters such as cardiac-specific biomarkers and echocardiographic measurements.
Detailed description
Worldwide, the incidence of heart valve disease is increasing. Improved surgical techniques, rising age and possibility for re-operation leads to a rising number of patients having heart valve surgery. The gap between hospital discharge and returning to normal life is obvious. Integrated rehabilitation could probably reduce hospital readmissions, increase physical capacity and increase self-rated mental health and quality of life. Therefore the aim of this study is to explore if patients after heart valve surgery will benefit from an integrated rehabilitation programme consisting of physical exercise and psycho-educational intervention.
A randomized clinical trial is conducted to investigate the effect and meaning of an integrated rehabilitation programme on the physical and psychosocial functioning of patients after heart valve surgery. The trial is a parallel arm design.
A mixed methods embedded experimental design is chosen to include both quantitative and qualitative data to evaluate the intervention. The intervention consists of five psycho-educational consultations provided by specialized nurses and a twelve week individualized exercise training programme provided by physiotherapists. A qualitative post-intervention study will explore rehabilitation participation experiences.
Along with the above stated hypothesis, it will be observed whether integrated rehabilitation can reduce anxiety, depression, health care utilisation, mortality and work cessation.
210 patients will be included.
Validated questionnaires (e.g. SF-36), cardiopulmonary exercise testing, 6 minute walking test, echocardiography, cardiac-specific biomarkers and qualitative interviews will be used to evaluate the effect and meaning of the programme.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Integrated rehabilitationPatients receive integrated rehabilitation |
| Control group | No intervention | –Patients receive usual follow-up care without physical exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted to hospital for elective heart valve surgery at Rigshospitalet, Denmark
- 18 years or older
- Speak and understand Danish
- Providing written informed consent
Key exclusion criteria (6 listed)
- Known ischemic heart disease prior to heart valve surgery
- Is included in an other clinical trial investigating the effects of physical training and psycho-educational intervention
- Unable to understand and cooperate to study instructions
- Pregnant and/or breast feeding
- Performing exercise training at high level and several times a week
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 |
|---|---|---|
| Integrated rehabilitationIntegrated rehabilitation consisting of exercise training (3 times per week (1 hour) for 12 weeks) and psycho-educational care (5 consultations over 6 months by special trained nurses). | Other | Intervention group |
Primary outcome
Change in physical capacity
Time frame: 1,4,12 months
Measured by Vo2peak by ergospirometry testing
1 secondary outcome
Change in self-rated mental health and quality of life
Time frame: 0, 1, 4, 6, 12 and 24 months
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 13 Nov 2015.
- Derived from this study: PubMed 27492941Sibilitz KL, Berg SK, Rasmussen TB, Risom SS, Thygesen LC, Tang L, Hansen TB, Johansen PP, Gluud C, Lindschou J, Schmid JP, Hassager C, Kober L, Taylor RS, Zwisler AD. Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial. Heart. 2016 Dec 15;102(24):1995-2003. doi: 10.1136/heartjnl-2016-309414. Epub 2016 Aug 4.
- Derived from this study: PubMed 25887433Sibilitz KL, Berg SK, Hansen TB, Risom SS, Rasmussen TB, Hassager C, Kober L, Gluud C, Thygesen LC, Lindschou J, Schmid JP, Taylor RS, Zwisler AD. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control: the CopenHeartVR trial. Trials. 2015 Feb 5;16:38. doi: 10.1186/s13063-015-0562-z.
- Derived from this study: PubMed 23782510Sibilitz KL, Berg SK, Hansen TB, Risom SS, Rasmussen TB, Hassager C, Kober L, Steinbruchel D, Gluud C, Winkel P, Thygesen LC, Hansen JL, Schmid JP, Conraads V, Brocki BC, Zwisler AD. Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial. Trials. 2013 Apr 22;14:104. doi: 10.1186/1745-6215-14-104.
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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.
Kirstine Laerum Sibilitz, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Ann-Dorthe Zwisler, MD, Ph.d. principal investigator
Rigshospitalet / Copenhagen University Hospital, National Institute of Public Health, University of Southern Denmark
Selina Kikkenborg Berg, Ph.d. principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Integrated rehabilitation in people with Heart Valve Disease, 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 4 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 13 Nov 2015. 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?
Change in physical capacity (time frame: 1,4,12 months). 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 NCT01558765, which also lists 3 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 13 Nov 2015.