CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis
NCT ID: NCT01512615
Last Updated: 2019-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
117 participants
INTERVENTIONAL
2011-12-31
2018-10-15
Brief Summary
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The hypothesis is, that integrated rehabilitation can improve mental health, physical capacity and other factors.
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Detailed Description
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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 treated for IE. The trial is a multi-centre, 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 and a survey-based pre-study will be undertaken, to investigate post-discharge experiences and rehabilitation needs of patients treated for IE. A qualitative post-intervention study will explore rehabilitation participation experiences.
The hypothesis is, that integrated rehabilitation can improve mental health, physical capacity, self-rated health, quality of life, nutritional status, sleep-quality and body-image and reduce anxiety, depression, fatigue, health care utilisation, work cessation and mortality in patients treated for IE and that it is cost effective.
150 patients treated for leftsided- (native- or prosthetic valve) or cardiac device endocarditis will be included in the trial
Questionnaires, cardiopulmonary testing, 6 minute walking test and qualitative interviews will be used to evaluate the effect and meaning of the programme.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention group
Complex Cardiac Rehabilitation
Complex Cardiac rehabilitation
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)
Control group
Usual care
Control group
Usual care, clinical control as provided by treating heart centre
Interventions
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Complex Cardiac rehabilitation
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)
Control group
Usual care, clinical control as provided by treating heart centre
Eligibility Criteria
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Inclusion Criteria
* treated for leftsided- (native- or prosthetic valve) or cardiac device endocarditis based on Duke Criteria
* 18 years or older
* speaking and understanding Danish
* providing written informed consent
Exclusion Criteria
* 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
18 Years
95 Years
ALL
No
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Selina Kikkenborg Berg
Principal investigator
Principal Investigators
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Trine B Rasmussen, PhD fellow
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital Rigshospitalet, University Hospital Gentofte
Selina K Berg, MScN, Ph.d.
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital Rigshospitalet, University Hospital Gentofte
Ann-Dorthe Zwisler, MD, Ph.d.
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital Rigshospitalet, National Institute of Public Health, University of Southern Denmark
Henning Bundgaard, MD, Ph.d.
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Philip Moons, Prof, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Health Services and Nursing Research, KU Leuven-University of
Locations
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Rigshospitalet / gentofte hospital
Copenhagen, , Denmark
Countries
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References
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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.
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.
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.
Other Identifiers
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RHCopenHeartIE
Identifier Type: -
Identifier Source: org_study_id
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