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

Phase

N/A

Condition

Mental Disability

Surgery

Memory Loss

Treatment

Comprehensive training program

Active control

Clinical Study ID

NCT04889417

U11775

1R01AG061161-01A1

Ages > 60
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

≥60 years old
undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days

Exclusion

Exclusion Criteria:

Blind, deaf, or inability to understand English as these conditions would precludethe ability to perform the proposed comprehensive program and prevent assessmentwith 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 ofa severity that precludes ability to self-consent and, thus, also participation instudy interventions)
Inability to obtain informed consent ≥2 weeks before scheduled surgery
Surgical team unwilling to allow physical activity or other components of theintervention
Inability or unwillingness to utilize a tablet device, laptop, or email
Co-enrolled in another interventional trial examining similar outcomes or currentenrollment in a study that does not allow co-enrollment

Study Design