The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is testing the hypothesis that a pragmatic program combining computerized cognitive training and physical training throughout the perioperative period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. To accomplish these goals, the Investigators are randomizing 250 patients ≥60 years old undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days to a pragmatic comprehensive training program (computerized cognitive training and supervised progressive physical exercise) or to active control (control computer game, stretching exercises) for 2-4 weeks prior to surgery and for 3 months after discharge. At baseline and after discharge, the Investigators will assess global cognition, activities of daily living, depression, endothelial and blood brain barrier function (blood biomarkers), and neuroimaging (anatomical and functional MRI). In this early stage trial, the Investigators will determine if certain subgroups benefit most, program aspects with greatest effect on outcomes, mechanistic associations with outcomes, and additional exploratory analyses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
250
The COPE-iOS program is a pragmatic comprehensive training program that combines computerized cognitive training and progressive supervised video conference physical exercise sessions performed 2-4 weeks prior to surgery and for 3 months after discharge.
The active attention control will include control computer games and supervised video conference stretching exercises performed 2-4 weeks prior to surgery and for 3 months after discharge.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Global cognition
Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery
Time frame: 3 months after discharge
Global cognition
Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery
Time frame: 12 months after discharge
Basic activities of daily living
Katz activities of daily living
Time frame: 3 and 12 months after discharge
Instrumental activities of daily living
Functional activities questionnaire
Time frame: 3 and 12 months after discharge
Depression
Depression Anxiety and Stress Scale (DASS)
Time frame: 3 and 12 months after discharge
Endothelial injury
Plasma biomarker
Time frame: day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
Blood brain barrier injury
Plasma biomarker
Time frame: day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
Brain magnetic resonance imaging
Anatomical and functional magnetic resonance imaging of the brain
Time frame: 3 months after discharge
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