COPEiOS: COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Computerized brain game training and online interactive physical exercise training |
Behavioral: Comprehensive training program
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.
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| Active Comparator: Control Control computer games and online interactive stretching exercises. |
Behavioral: Active control
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.
|
Outcome Measures
Primary Outcome Measures
- Global cognition [3 months after discharge]
Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery
Secondary Outcome Measures
- Global cognition [12 months after discharge]
Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery
- Basic activities of daily living [3 and 12 months after discharge]
Katz activities of daily living
- Instrumental activities of daily living [3 and 12 months after discharge]
Functional activities questionnaire
- Depression [3 and 12 months after discharge]
Hospital Anxiety and Depression Scale (HADS) which ranges from 0 to 21 for depression with higher scores indicating more depression symptoms
- Endothelial injury [day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge]
Plasma biomarker
- Blood brain barrier injury [day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge]
Plasma biomarker
- Brain magnetic resonance imaging [3 months after discharge]
Anatomical and functional magnetic resonance imaging of the brain
Other Outcome Measures
- Program compliance [before surgery up to 3 months after discharge]
Compliance with program, feasibility
- Delirium [up to 14 days in the hospital]
Confusion assessment method in the ICU
- Length of stay [through hospital admission, an average of up to 14 days]
Length of stay in the hospital
- Discharge location [through hospital admission, an average of up to 14 days]
Home, rehabilitation, skilled nursing facility, hospice
- Functional status [3 and 12 months after discharge]
Duke Activity Status Index
- Aerobic exercise capacity [3 months after discharge]
6-minute walk test
- Chronic Pain [3 and 12 months after discharge]
Behavioral Pain Index
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥60 years old
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undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days
Exclusion Criteria:
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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
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Prisoners
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Severe frailty or physical impairment that prohibits participation in the program
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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)
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Inability to obtain informed consent ≥2 weeks before scheduled surgery
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Surgical team unwilling to allow physical activity or other components of the intervention
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Inability or unwillingness to utilize a tablet device, laptop, or email
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Co-enrolled in another interventional trial examining similar outcomes or current enrollment in a study that does not allow co-enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37212 |
Sponsors and Collaborators
- Vanderbilt University Medical Center
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Christopher G Hughes, MD, Vanderbilt University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- U11775
- 1R01AG061161-01A1