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CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery (CopenHeartVR)

This study has been completed.
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark Identifier:
First received: March 16, 2012
Last updated: November 12, 2015
Last verified: November 2015

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.

Condition Intervention Phase
Heart Valve Disease Other: Integrated rehabilitation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: CopenHeartVR - A Randomized Clinical Trial Investigating the Effect of Integrated Rehabilitation Versus Usual Care Without Physical Exercise After Heart Valve Surgery.

Resource links provided by NLM:

Further study details as provided by Selina Kikkenborg Berg, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Change in physical capacity [ Time Frame: 1,4,12 months ]
    Measured by Vo2peak by ergospirometry testing

Secondary Outcome Measures:
  • Change in self-rated mental health and quality of life [ Time Frame: 0, 1, 4, 6, 12 and 24 months ]
    Measured by total score and the mental health component scale (MSC) in the SF-36 questionnaire.

Enrollment: 147
Study Start Date: March 2012
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
Patients receive integrated rehabilitation
Other: Integrated rehabilitation
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).
No Intervention: Control group
Patients receive usual follow-up care without physical exercise

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Admitted to hospital for elective heart valve surgery at Rigshospitalet, Denmark
  • 18 years or older
  • Speak and understand Danish
  • Providing written informed consent

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01558765

Rigshospitalet / Copenhagen University Hospital
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: 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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Selina Kikkenborg Berg, Principal Investigator, RN, MSN, PhD, FESC., Rigshospitalet, Denmark Identifier: NCT01558765     History of Changes
Other Study ID Numbers: RHCopenHeartVR
Study First Received: March 16, 2012
Last Updated: November 12, 2015

Keywords provided by Selina Kikkenborg Berg, Rigshospitalet, Denmark:
Integrated rehabilitation programme
Exercise training
Psycho-educational care

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases processed this record on August 16, 2017