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Revalidatiebegeleiding van de patiŽnt voor en na een hartoperatie ter vermindering van complicaties en verbetering van de kwaliteit van het leven (Heart-ROCQ) - een haalbaarheid pilot studie


- candidate number22325
- NTR NumberNTR5246
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jun-2015
- Secondary IDs52279 
- Public TitleRevalidatiebegeleiding van de patiŽnt voor en na een hartoperatie ter vermindering van complicaties en verbetering van de kwaliteit van het leven (Heart-ROCQ) - een haalbaarheid pilot studie
- Scientific TitleHEART optimalization & lifestyle management in patients undergoing caRdiovascular Operations to prevent Complications and to improve Quality of life (Heart-ROCQ) -A feasibility pilot study
- ACRONYMHeart-ROCQ
- hypothesis
- Healt Condition(s) or Problem(s) studiedCardiothoracic surgery, Quality of life, Rehabilitation
- Inclusion criteria- Age > 18 years - Accepted for cardiovascular surgery under general anesthesia - Patients (age > 18 years) admitted for coronary bypass surgery, valve surgery or aortic surgery (or combined) - Bed available in the rehabilitation center during the post-operative clinical phase
- Exclusion criteria- Co-morbidities that prevent participation in one program elements (e.g. disorders to the nervous or musculoskeletal system that limits exercise capacity, severe COPD (GOLD class 3-4), non-coping behaviour/ addiction/ serious psychological illness) or when it is undesirable to exercise - Unable to understand or read Dutch instructions - Unable to sign informed consent before surgery - MRSA-positive - Pregnancy, childbearing potential
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 2-aug-2015
- planned closingdate3-jul-2016
- Target number of participants0
- InterventionsThis intervention consists of 1) a preoperative outward patient clinical optimization period (three times a week for 4-6 weeks), 2) a three week clinical rehabilitation period starting at four days after surgery and a subsequent four week outward patient clinical rehabilitation period (two times a week). During each phase, patients will regularly visit a physical therapist, a dietician and a psychologist to optimize general health and receive advices with regard to lifestyle management. Non-elective patients are starting with the second phase of the intervention.
- Primary outcomeThis study will mainly evaluate post-operative complications (infections, stroke, and heart rhythm problems), duration at the intensive care unit, hospital stay and mortality.
- Secondary outcomeSecondary, psychophysical parameters (e.g. delirium, post-operative cognitive decline, disability free survival, quality of life, physical fitness, labor participation, and life style) will be evaluated.
- TimepointsThere are five timepoints. The first two measurements (four to seven weeks before surgery (T0) and in the last week before surgery (T1) are baseline measurements and evaluate the preoperative outward patient phase in elective patients. The three measurements after surgery (four days after surgery (T2), at the end of the post-operative clinical phase (T3) and at the end of the post-operative outward patient phase (T4) will evaluate the two post-operative phases. A follow up measurement (T5) is performed after three to four months.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES J. Hartog
- CONTACT for SCIENTIFIC QUERIES J. Hartog
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD9-jun-2015 - 15-aug-2015


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