NCT01558765

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

3.2 years

First QC Date

March 16, 2012

Last Update Submit

November 12, 2015

Conditions

Heart Valve Disease

Keywords

RehabilitationIntegrated rehabilitation programmeExercise trainingPsycho-educational care

Outcome Measures

Primary Outcomes (1)

  • Change in physical capacity

    Measured by Vo2peak by ergospirometry testing

    1,4,12 months

Secondary Outcomes (1)

  • Change in self-rated mental health and quality of life

    0, 1, 4, 6, 12 and 24 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients receive integrated rehabilitation

Other: Integrated rehabilitation

Control group

NO INTERVENTION

Patients receive usual follow-up care without physical exercise

Interventions

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).

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet / Copenhagen University Hospital

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 27492941DERIVED

  • 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.

    PMID: 25887433DERIVED

  • 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.

    PMID: 23782510DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, RN, MSN, PhD, FESC.

Study Record Dates

First Submitted

March 16, 2012

First Posted

March 20, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

DK(1)