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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Cognitive Impairment
Intervention / Treatment

-

Contacts and Locations

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. ≥60 years old
  • 2. undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days
  • 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

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

Christopher G Hughes, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

2027-07-01