COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study
Purpose
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.
Conditions
- Cognitive Impairment
- Disability Physical
- Surgery
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥60 years old 2. 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 2. Prisoners 3. Severe frailty or physical impairment that prohibits participation in the program 4. 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) 5. Inability to obtain informed consent ≥2 weeks before scheduled surgery 6. Surgical team unwilling to allow physical activity or other components of the intervention 7. Inability or unwillingness to utilize a tablet device, laptop, or email 8. Co-enrolled in another interventional trial examining similar outcomes or current enrollment in a study that does not allow co-enrollment
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
- Masking Description
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention |
Computerized brain game training and online interactive physical exercise training |
|
|
Active Comparator Control |
Control computer games and online interactive stretching exercises. |
|
Recruiting Locations
Nashville, Tennessee 37212
More Details
- Status
- Recruiting
- Sponsor
- Vanderbilt University Medical Center