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CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery

This study is currently recruiting participants.
Verified March 2012 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01558765
First received: March 16, 2012
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Change in physical capacity [ Time Frame: 1,4,12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Measured by total score and the mental health component scale (MSC) in the SF-36 questionnaire.


Estimated Enrollment: 210
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558765

Contacts
Contact: Kirstine Laerum Sibilitz, MD +45 3545 1205/ +45 3545 1489 kirstine.laerum.sibilitz@rh.regionh.dk
Contact: Ann-Dorhte Zwisler, MD, Ph.d. +45 3061 6697 ado@dadlnet.dk

Locations
Denmark
Rigshospitalet / Copenhagen University Hospital Recruiting
Copenhagen, Denmark, 2100
Contact: Kirstine Laerum Sibilitz, MD     +45 35451489     kirstine.laerum.sibilitz@rh.regionh.dk    
Contact: The CopenHeart group     +45 35451205     copenheart@rh.regionh.dk    
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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, RN, MScN, 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

No publications provided

Responsible Party: Selina Kikkenborg Berg, Principal Investigator, RN, MSN, PhD, FESC., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01558765     History of Changes
Other Study ID Numbers: RHCopenHeartVR
Study First Received: March 16, 2012
Last Updated: March 19, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013