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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG061161-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Computerized brain game training and online interactive physical exercise training |
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| Control | Active Comparator | Control computer games and online interactive stretching exercises. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive training program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Global cognition | Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery | 3 months after discharge |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Program compliance | Compliance with program, feasibility, including sessions attended and completed, heart rate and exertion tracking during session | before surgery up to 3 months after discharge |
| Delirium |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher G Hughes, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41688121 | Derived | Rengel KF, Archer KR, Jackson JC, Raman R, Orun OM, Ellison T, Vanston SW, Ervin H, Lauck A, Provin M, Pandharipande PP, Hughes CG. Cognitive and physical exercise to improve outcomes after surgery (COPE-iOS) study: protocol for a randomised, controlled trial in the USA examining the efficacy of a combined cognitive and physical exercise programme performed before and after major surgery in improving cognitive and functional outcomes for older adults. BMJ Open. 2026 Feb 12;16(2):e110435. doi: 10.1136/bmjopen-2025-110435. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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Treatment assignment will be known only by the research coordinators, therapists, and research staff overseeing the administration of the program or active control. The remaining research staff, neuropsychology professionals performing the assessments, and clinicians will be blinded. Participants will be blinded to their group assignment.
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| Active control | Behavioral | 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. |
|
| 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 |
Confusion assessment method in the ICU
| up to 14 days in the hospital |
| Length of stay | Length of stay in the hospital | through hospital admission, an average of up to 14 days |
| Discharge location | Home, rehabilitation, skilled nursing facility, hospice | through hospital admission, an average of up to 14 days |
| Functional status | Duke Activity Status Index | 3 and 12 months after discharge |
| Chronic Pain | Behavioral Pain Index | 3 and 12 months after discharge |
| Adverse events | Safety evaluated by adverse event monitoring, including physical injury (e.g., discomfort, falls, myocardial ischemia, syncope, dyspnea), above maximum heart rate, and fatigue | before surgery up to 3 months after discharge |