To assess perioperative physical activity and fitness, and muscle strength in cardiac surgical patients and to explore the association with POCD after heart surgery.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters will be:
• Pre-operative levels of physical activity as assessed by the SQUASH
questionnaire and the SenseWear activity meter
• Pre-operative mobility/fitness as assessed by the get-up-and-go test
• Pre- and operative muscle strength, as assessed by a simple mechanical device.
• Development of POCD, defined as a decline of cognitive performance (relative
to baseline) of >= 2 SD in 2 or more of the 4 cognitive tests.
Secondary outcome
Secondary outcome parameters will include routinely recorded process and
outcome variables.
Background summary
Post-operative cognitive decline (POCD) is a common after cardiac surgery,
particularly in the elderly. Epidemiological studies show that the risk factors
include advanced age and low baseline cognitive function. The reasons for this
are uncertain. Some theories tend to focus on the inflammatory response to
surgery and anesthesia, but in a recent study at the UMCG we found no
association between inflammatory marker levels and POCD in patients undergoing
coronary artery bypass surgery. We have not entirely abandoned the inflammation
hypothesis (and are collaborating with the group of Dr Barbara van Leeuwen on a
larger scale study - METC 2014/095 - of the relationship between perioperative
inflammatory state and POCD) in patients undergoing oncological surgery). We
also plan to examine other possible hypotheses.
In general physical activity is associated with better health, and muscle
strength is a marker for physical fitness. Recent work in elderly non-surgical
population groups suggests an association between low muscle mass and muscle
weakness, and cognitive decline. The reasons for this association are not
clear, although there is some evidence to suggest physical activity and a good
muscle mass suppresses harmful inflammatory activity. The relation between
preoperative activity and physical fitness, and the incidence of POCD in
cardiac surgical patients is unknown. We hypothesize that preoperative and
postoperative physical inactivity and poor fitness may be associated related
towith POCD and other adverse outcomes changes in cardiac surgical patients.
Study objective
To assess perioperative physical activity and fitness, and muscle strength in
cardiac surgical patients and to explore the association with POCD after heart
surgery.
Study design
Observational study
Study burden and risks
In this study the participants will have no benefit. Due to the observational
and non-invasive nature of the study, the risks of participation are minimal.
The burden of participation is modest. In addition to usual clinical care, only
cognitive tests, questionnaires and fitness tests will be applied. Patients
selected for the study will be asked to complete the SQUASH questionnaires
about their physical activity before and 3 months after, their operation. It
takes about 10 minutes to do this. CogState tests (computerized cognitive
function tests) will be performed 3 times - a practise run and a baseline test
before surgery and then again 3 months after surgery. Before the CogOGsState
test the patient will be asked to complete a HADS (anxiety and depression)
questionnaire. It takes a couple of minutes to complete the HADS, and about 15
mins to complete each battery of CogsState tests. In order to get an impression
of physical fitness, hand grip strength and the get-up-and-go test will be
performed. The hand grip strength will be measured at the preoperative
screening clinic and also after 3 days and again 3 months after surgery. The
timed get-up-and-go test will be performed twice at the pre-operative screening
visit and 3 months after surgery. The patient is asked for this test to stand
up (from sitting), walk 3 metres, and return to the sitting position, if
possible three times. General health perception and quality of life will be
assessed with the SP36 questionnaire and the EQ 5D test, both performed pre and
3 months postoperative. These questionnaires take a few minutes
hanzeplein 1
groningen 9713 EZ
NL
hanzeplein 1
groningen 9713 EZ
NL
Listed location countries
Age
Inclusion criteria
- Scheduled for elective cardiac coronary surgery, and booked for routine clinical assessment on the cardiosurgical preoperative screening unit.
- 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
- Exentended 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49262.042.14 |