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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Surgery; Disability Physical
• Intervention / Treatment: Behavioral: Comprehensive training program; Behavioral: Active control

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Computerized brain game training and online interactive physical exercise training	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.
Active Comparator: Control; Control computer games and online interactive stretching exercises.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global cognition	Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery	3 months after discharge

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program compliance	Compliance with program, feasibility	before surgery up to 3 months after discharge
Delirium	Confusion assessment method in the ICU	up to 14 days in the hospital
Length of stay	Length of stay in the hospital	through hospital admission, an average of up to 14 days
Discharge location	Home, rehabilitation, skilled nursing facility, hospice	through hospital admission, an average of up to 14 days
Functional status	Duke Activity Status Index	3 and 12 months after discharge
Aerobic exercise capacity	6-minute walk test	3 months after discharge
Chronic Pain	Behavioral Pain Index	3 and 12 months after discharge

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Anticipated): July 31, 2026
• Study Completion (Anticipated): July 1, 2027

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: U11775; 1R01AG061161-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No