Cognitive Impairment, Disability Physical, Surgery
Conditions
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.
Interventions
BEHAVIORALComprehensive 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.
BEHAVIORALActive 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.
Sponsors
National Institute on Aging (NIA)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥60 years old 2. undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days
Exclusion criteria
1. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global cognition | 3 months after discharge | Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Depression Anxiety and Stress Scale (DASS) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Program compliance | before surgery up to 3 months after discharge | Compliance with program, feasibility, including sessions attended and completed, heart rate and exertion tracking during session |
| Delirium | up to 14 days in the hospital | Confusion assessment method in the ICU |
| 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 |
| Chronic Pain | 3 and 12 months after discharge | Behavioral Pain Index |
| Adverse events | before surgery up to 3 months after discharge | Safety evaluated by adverse event monitoring, including physical injury (e.g., discomfort, falls, myocardial ischemia, syncope, dyspnea), above maximum heart rate, and fatigue |
| Length of stay | through hospital admission, an average of up to 14 days | Length of stay in the hospital |
Countries
United States
Outcome results
None listed