COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study (COPEiOS)
R
Roman Natoli, MD
Primary Investigator
Enrolling By Invitation
60 years and older
All
Phase
N/A
250 participants needed
1 Location
Overview
The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study isg the hypothesis that a pragmatic program combining computerized cognitive training andhysical 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 majordiac surgery with expected hospitalization ≥3 days to a pragmatic comprehensiveg program (computerized cognitive training and supervised progressive physical) or to active control (control computer game, stretching exercises) for 2-4 weeksurgery and for 3 months after discharge. At baseline and after discharge, thevestigators will assess global cognition, activities of daily living, depression,dothelial and blood brain barrier function (blood biomarkers), and neuroimaging (anatomicald functional MRI). In this early stage trial, the Investigators will determine if certainubgroups benefit most, program aspects with greatest effect on outcomes, mechanisticwith outcomes, and additional exploratory analyses.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Cognitive Impairment, Disability Physical, Surgery
-
Age: 60 Years
-
Gender: All
Inclusion Criteria:
- ≥60 years old
- 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 thebility to perform the proposed comprehensive program and prevent assessment with theudy 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 of averity that precludes ability to self-consent and, thus, also participation in studyventions)
- Inability to obtain informed consent ≥2 weeks before scheduled surgery
- Surgical team unwilling to allow physical activity or other components of thevention
- Inability or unwillingness to utilize a tablet device, laptop, or email
- Co-enrolled in another interventional trial examining similar outcomes or currentudy that does not allow co-enrollment
Updated on
15 May 2024.
Study ID: U11775
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