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Physical fitness predictive for morbidity after heartsurgery


- candidate number20386
- NTR NumberNTR4861
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-okt-2014
- Secondary IDsNL2014 Fitness METC 2014/219
- Public TitlePhysical fitness predictive for morbidity after heartsurgery
- Scientific TitleAssessment of Physical Fitness and Activity in cardiac surgery patients in relation to cognitive function decline and perioperative morbidity
- ACRONYM
- hypothesisTo assess perioperative physical activity and fitness, and muscle strength in cardiac surgical patients and to explore the association with POCD after heart surgery
- Healt Condition(s) or Problem(s) studiedCardiac surgery
- Inclusion criteria•In order to be eligible to participate in this study, a subject must meet all of the following criteria: Scheduled for elective cardiac coronary surgery, and booked for routine clinical assessment on the cardiosurgical preoperative screening unit.
•Age 55 years and older
•Able to stand and walk independently
•Able to participate in the online screenings module for cognitive function (ie able to operate a computer touch pad or mouse, and to read large text on a computer screen).
•They should be prepared to allow a researcher to visit them at home 3 months after their operation.
•Patients need to be able to perform the handgrip strength test on both sides.
- Exclusion criteria•A potential subject who meets any of the following criteria will be excluded from participation in this study: Extended postoperative ICU stay is expected.
•Inability to understand or read Dutch instructions
•Recent history of depression or severe anxiety
•History of dementia or other neurological disorders
•History of stroke, or other severe cerebrovascular insults
•Patient is not able to perform get-up-and-go test or any of the other tests
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-nov-2014
- planned closingdate31-dec-2016
- Target number of participants100
- InterventionsNone
- Primary outcomeThe primary parameters are:
-Physical activity (Squash questionnaire)
-Muscle strength (poundsforce) baseline, after 3-4 days post IC and after 3 months
-Incidence of cognitive dysfunction at 3 months (compared to baseline)
-Results of get-up-and-go test (secs) baseline and after 3 months
- Secondary outcome1.Analysis of factors associated with POCD: Multiple binary logistic regression analysis will be performed to determine the relative strengths of association between potential factors (age, baseline cognitive function, physical inactivity, baseline inflammatory markers) and POCD.
2.Correlation analysis and ANOVA after dichotomisation of physical activity and fitness with morbidity and outcome variables
- Timepoints3 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R. Spanjersberg
- CONTACT for SCIENTIFIC QUERIES A.R. Absalom
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD16-okt-2014 - 22-nov-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl