COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study

Study Overview
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Brief Summary
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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.

Official Title
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COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study

Conditions
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Cognitive Impairment, Disability Physical, Surgery

Intervention / Treatment
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* Behavioral: Comprehensive training program
* Behavioral: Active control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥60 years old undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days Exclusion Criteria: Blind, deaf, or inability to understand English as these conditions would preclude the ability to perform the proposed comprehensive program and prevent assessment with the study instruments Prisoners Severe frailty or physical impairment that prohibits participation in the program Cognitively unable to consent for surgery (i.e., dementia or cognitive impairment of a severity that precludes ability to self-consent and, thus, also participation in study interventions) Inability to obtain informed consent ≥2 weeks before scheduled surgery Surgical team unwilling to allow physical activity or other components of the intervention Inability or unwillingness to utilize a tablet device, laptop, or email Co-enrolled in another interventional trial examining similar outcomes or current enrollment in a study that does not allow co-enrollment

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Computerized brain game training and online interactive physical exercise training | Behavioral: Comprehensive training program<br>* 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.<br>|
| Active Comparator: Control<br>Control computer games and online interactive stretching exercises. | Behavioral: Active control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global cognition | Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery | 3 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global cognition | Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery | 12 months after discharge | 
| Basic activities of daily living | Katz activities of daily living | 3 and 12 months after discharge | 
| Instrumental activities of daily living | Functional activities questionnaire | 3 and 12 months after discharge | 
| Depression | Depression Anxiety and Stress Scale (DASS) | 3 and 12 months after discharge | 
| Endothelial injury | Plasma biomarker | day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge | 
| Blood brain barrier injury | Plasma biomarker | 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 | 3 months after discharge |