NCT01512615

Brief Summary

The aim of the study is to describe the effect and meaning of an integrated rehabilitation programme, consisting of physical training and psycho-educational care, for patients treated for infective endocarditis. The hypothesis is, that integrated rehabilitation can improve mental health, physical capacity and other factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

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

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

4.8 years

First QC Date

January 11, 2012

Last Update Submit

September 10, 2019

Conditions

Infective Endocarditis

Keywords

RehabilitationExercise trainingPsycho-educational care

Outcome Measures

Primary Outcomes (1)

  • Change in Mental component scale

    Measured by the mental component scale (MCS) in the SF-36 questionnaire

    1, 4, 6 and 12 months

Secondary Outcomes (1)

  • Change in physical capacity

    1, 4 and 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Complex Cardiac Rehabilitation

Other: Complex Cardiac rehabilitation

Control group

EXPERIMENTAL

Usual care

Other: Control group

Interventions

Complex Cardiac rehabilitationOTHER

Complex Cardiac Rehabilitation consisting of exercise training (minimum 3 times a week for a total of twelve weeks) and psychoeducational care (5 sessions over 6 months)

Intervention group
Control groupOTHER

Usual care, clinical control as provided by treating heart centre

Control group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients:
  • treated for leftsided- (native- or prosthetic valve) or cardiac device endocarditis based on Duke Criteria
  • years or older
  • speaking and understanding Danish
  • providing written informed consent

You may not qualify if:

  • Patients:
  • unable to understand study instructions
  • with an ischemic event within the past 6 months
  • who are pregnant or breastfeeding
  • with reduced ability to follow the planned programme due to i.e. substance abuse problems or other somatic illness
  • with considerable illness in the musculoskeletal system or with physical disability, which complicates exercise training
  • whose physician advise against participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet / gentofte hospital

Copenhagen, 2100, Denmark

Location

Related Publications (3)

  • Rasmussen TB, Zwisler AD, Risom SS, Sibilitz KL, Christensen J, Bundgaard H, Moons P, Thygesen LC, Lindschou J, Norekval TM, Berg SK. Comprehensive cardiac rehabilitation for patients following infective endocarditis: results of the randomized CopenHeartIE trial. Eur J Cardiovasc Nurs. 2022 Apr 9;21(3):261-270. doi: 10.1093/eurjcn/zvab047.

    PMID: 34089600DERIVED

  • Rasmussen TB, Zwisler AD, Moons P, Berg SK. Insufficient living: experiences of recovery after infective endocarditis. J Cardiovasc Nurs. 2015 May-Jun;30(3):E11-9. doi: 10.1097/JCN.0000000000000144.

    PMID: 24704921DERIVED

  • Rasmussen TB, Zwisler AD, Sibilitz KL, Risom SS, Bundgaard H, Gluud C, Moons P, Winkel P, Thygesen LC, Hansen JL, Norekval TM, Berg SK; CopenHeartIE Group. A randomised clinical trial of comprehensive cardiac rehabilitation versus usual care for patients treated for infective endocarditis--the CopenHeartIE trial protocol. BMJ Open. 2012 Nov 21;2(6):e001929. doi: 10.1136/bmjopen-2012-001929. Print 2012.

    PMID: 23175738DERIVED

MeSH Terms

Conditions

Endocarditis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Trine B Rasmussen, PhD fellow

    Copenhagen University Hospital Rigshospitalet, University Hospital Gentofte

    PRINCIPAL INVESTIGATOR

  • Selina K Berg, MScN, Ph.d.

    Copenhagen University Hospital Rigshospitalet, University Hospital Gentofte

    PRINCIPAL INVESTIGATOR

  • Ann-Dorthe Zwisler, MD, Ph.d.

    Copenhagen University Hospital Rigshospitalet, National Institute of Public Health, University of Southern Denmark

    PRINCIPAL INVESTIGATOR

  • Henning Bundgaard, MD, Ph.d.

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Philip Moons, Prof, PhD

    Centre for Health Services and Nursing Research, KU Leuven-University of

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 19, 2012

Study Start

December 1, 2011

Primary Completion

October 1, 2016

Study Completion

October 15, 2018

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations

DK(1)