NCT04889417

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cognitive Impairment
• Disability Physical
• Surgery

Interventions

Type	Name	Description
BEHAVIORAL	Comprehensive 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.
BEHAVIORAL	Active 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.

Timeline

• Start date: 2021-10-12
• Primary completion: 2026-10-31
• Completion: 2027-07-01
• First posted: 2021-05-17
• Last updated: 2025-12-02

Locations

1 site across 1 country: United States