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

Last updated: April 29, 2024
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Mild Cognitive Impairment

Mental Disability

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:

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

Exclusion

Exclusion Criteria:

  1. Blind, deaf, or inability to understand English as these conditions would preclude theability to perform the proposed comprehensive program and prevent assessment with thestudy 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 aseverity that precludes ability to self-consent and, thus, also participation in studyinterventions)
  5. Inability to obtain informed consent ≥2 weeks before scheduled surgery
  6. Surgical team unwilling to allow physical activity or other components of theintervention
  7. Inability or unwillingness to utilize a tablet device, laptop, or email
  8. Co-enrolled in another interventional trial examining similar outcomes or currentenrollment in a study that does not allow co-enrollment

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Comprehensive training program
Phase:
Study Start date:
October 12, 2021
Estimated Completion Date:
July 01, 2027

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.