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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Patients receive integrated rehabilitation |
|
| Control group | No Intervention | Patients receive usual follow-up care without physical exercise |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated rehabilitation | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical capacity | Measured by Vo2peak by ergospirometry testing | 1,4,12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 1, 4, 6, 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirstine Laerum Sibilitz, MD | Rigshospitalet, Denmark | Principal Investigator |
| Ann-Dorthe Zwisler, MD, Ph.d. | Rigshospitalet / Copenhagen University Hospital, National Institute of Public Health, University of Southern Denmark | Principal Investigator |
| Selina Kikkenborg Berg, Ph.d. | Rigshospitalet, Denmark | Principal Investigator |
| Christian Hassager, MD, DMSc | Rigshospitalet, Denmark | Principal Investigator |
| Lars Køber, MD, DMSc | Rigshospitalet, Denmark | Principal Investigator |
| Daniel Steinbrüchel, MD, DMSc | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet / Copenhagen University Hospital | Copenhagen | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27492941 | Derived | 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. | |
| 25887433 |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Derived |
| Sibilitz 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. |
| 23782510 | Derived | Sibilitz 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. |