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CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis

CopenHeart IE - A Randomized Clinical Trial Investigating the Effect and Meaning of Integrated Rehabilitation Versus Usual Follow-up of Patients Treated for Infective Endocarditis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01512615
Enrollment
117
Registered
2012-01-19
Start date
2011-12-31
Completion date
2018-10-15
Last updated
2019-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infective Endocarditis

Keywords

Rehabilitation, Exercise training, Psycho-educational care

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.

Detailed description

Infective endocarditis (IE) is among the most serious infectious diseases in the western world. Treatment requires lengthy hospitalization, high dosage antibiotics and possible valve replacement surgery. Studies indicate that patients experience persisting physical symptoms, diminished quality of life and difficulties returning to work, up to a year post-discharge. No studies investigating the effect of, interventions aimed at relieving these problems, have been published. 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.

Interventions

OTHERComplex 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)

OTHERControl group

Usual care, clinical control as provided by treating heart centre

Sponsors

University Hospital, Gentofte, Copenhagen
CollaboratorOTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

RCT

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

Patients: * 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

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Mental component scale1, 4, 6 and 12 monthsMeasured by the mental component scale (MCS) in the SF-36 questionnaire

Secondary

MeasureTime frameDescription
Change in physical capacity1, 4 and 6 monthsMeasured by Peak VO2 via ergospirometry testing

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026