The Influence of Cognitive Decline on Quality of Life After Coronary Bypass
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in cognitive functioning
研究概览
简要总结
During the last decades improvements in operative techniques and perioperative care have led to a steady decline in mortality after cardiac surgery. Good survival rates have been shown repeatedly although elderly patients have an increased risk for prolonged hospital stay and postoperative complications such as neurological and pulmonary problems. Post-operative cognitive decline (POCD) is common after cardiac surgery and although this cognitive decline can be subtle, in elderly vulnerable patients even a small decline can have important consequences such as a decreased quality of life and loss of independence. Recent studies among patients after coronary artery bypass grafting (CABG) found that the incidence of POCD varied between 30-60% depending on cognitive tests, time of assessment and patient populations.
Cognitive and physical impairment frequently co-occur in older people. The association between cognitive impairment and functional disability has been investigated in several studies, which demonstrated that cognitive decline is associated with functional disability, also after cardiac surgery. One method for estimation of patients' physical performance is to evaluate sarcopenia. Sarcopenia is defined as a syndrome characterised by progressive and generalised loss of skeletal muscle mass and strength, leading to an increased risk of adverse outcomes such as physical disability, poor quality of life and death. Data on the prevalence of sarcopenia in community-dwelling residents or nursing-homes are widely available, but little is known on (elderly) hospitalized patients after cardiac surgery. The aim of this study is to evaluate the association between post-operative cognitive decline, quality of life (QoL) and sarcopenia in adult patients after coronary artery bypass grafting. The investigators hypothesize that a decreased postoperative QoL is mainly explained by POCD, therefore the primary research question of this study is: What is the influence of post-operative cognitive decline on QoL after CABG? The secondary research question is: Is there an association between postoperative sarcopenia and a decreased postoperative QoL?
详细描述
Study design:
The investigators will conduct a prospective observational cohort study to evaluate QoL, cognitive decline and sarcopenia in adult patients after coronary artery bypass grafting. The investigators hypothesize that cognitive decline is more associated with QoL than sarcopenia. QoL will be measured using the RAND-36 questionnaire. Cognitive functioning will be measured using several cognitive tests and sarcopenia will be evaluated by measuring muscle mass and muscle strength. The investigators will explore different subgroups according to age including elderly patients (e.g. patients aged 80 years or older at the time of surgery), according to a prolonged stay at the Intensive Care Unit (>24 hours) and according to comorbidities (i.e. diabetes, pulmonary disease, renal failure).
Data collection method:
Routinely, patients planned for CABG are admitted to the cardiothoracic ward one day before surgery. On the day of admittance (one day before surgery) patients will be asked to perform a simple brief battery of 4 computerized tests of cognitive function. At the same time, muscle mass will be assessed using a bioelectrical impedance instrument (BIA) and muscle strength will be assessed using a handgrip strength device. Patients wil also be asked to fill-in a quality of life questionnaire (RAND-36 health survey). Three days after surgery assessments of cognitive functioning, muscle mass and muscle strength will be repeated. Six months after surgery patients will be visited at home where cognitive functioning, muscle strength, muscle mass and QoL will be reassessed.
Study parameters:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients scheduled for elective, isolated on-pump CABG
- •able to stand and walk independently
- •able to participate in the online screenings module for cognitive function to reduce the amount of missing data for cognitive function
排除标准
- •Pre-existing neurological deficits
- •Psychiatric illness
- •previous cardiac surgery
- •pre-existing muscular diseases or missing extremities
- •presence of an Internal Cardioverter Defibrillator (ICD), assist device or pacemaker
- •large amounts of metal in or around the body
- •inability to read or understand Dutch instructions
结局指标
主要结局
Change in cognitive functioning
时间窗: Two sets of cognitive tests will be performed on the day before surgery; one practice test and a second test that will be used as a baseline test. Follow-up tests will be performed at 3 days and 6 months after surgery.
Cognitive function will be assessed using a set of computerised cognitive tests.This set of tests consists of the detection task, the identification task, the one card learning task and the one back task assessing psychomotor speed, selective attention, visual learning and working memory, respectively.
Change in quality of life
时间窗: at baseline (one day before surgery) and 6 months after surgery
Quality of life will be assessed using the RAND-36 version 2 questionnaire, a widely validated questionnaire including eight health domains; physical functioning, social functioning, role limitations due to physical health problems, role limitations due to emotional problems, mental health, vitality, pain and general health perception. Outcomes at each domain will be defined on a scale from a minimum score of 0 to a maximum score of 100. A higher score is equivalent to a better health.
次要结局
- Change in muscle strength(All tests will be performed on the day before surgery, three days after surgery and 6 months after surgery.)
- Change in muscle mass(All tests will be performed on the day before surgery, three days after surgery and 6 months after surgery.)
研究者
I.C.C. van der Horst
Associate professor
University Medical Center Groningen