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

Not Applicable

Recruiting

• Conditions: Disability Physical; Cognitive Impairment; Surgery
• Interventions: Behavioral: Comprehensive training program; Behavioral: Active control

• Registration Number: NCT04889417
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-17
• Study Start: 2021-10-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-07-31
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Comprehensive training program	Computerized brain game training and online interactive physical exercise training
Control	Active control	Control computer games and online interactive stretching exercises.

Primary Outcome Measures

Name	Time	Method
Global cognition	3 months after discharge	Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery

Secondary Outcome Measures

Name	Time	Method
Global cognition	12 months after discharge	Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery
Basic activities of daily living	3 and 12 months after discharge	Katz activities of daily living
Instrumental activities of daily living	3 and 12 months after discharge	Functional activities questionnaire
Depression	3 and 12 months after discharge	Depression Anxiety and Stress Scale (DASS)
Endothelial injury	day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge	Plasma biomarker
Brain magnetic resonance imaging	3 months after discharge	Anatomical and functional magnetic resonance imaging of the brain
Blood brain barrier injury	day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge	Plasma biomarker

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States