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

NCT04889417 | Active Not Recruiting DMC

• 2 other identifiers: U117751R01AG061161-01A1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Disability Physical; Surgery

Outcome Measures

Primary Outcomes (1)

• Global cognition

  Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery

  3 months after discharge

Secondary Outcomes (7)

• Global cognition

  12 months after discharge

• Basic activities of daily living

  3 and 12 months after discharge

• Instrumental activities of daily living

  3 and 12 months after discharge

• Depression

  3 and 12 months after discharge

• Endothelial injury

  day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge

Other Outcomes (7)

• Program compliance

  before surgery up to 3 months after discharge

• Delirium

  up to 14 days in the hospital

• Length of stay

  through hospital admission, an average of up to 14 days

Study Arms (2)

Intervention

EXPERIMENTAL

Computerized brain game training and online interactive physical exercise training

Behavioral: Comprehensive training program

Control

ACTIVE COMPARATOR

Control computer games and online interactive stretching exercises.

Behavioral: Active control

Interventions

Comprehensive training program BEHAVIORAL

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.

Intervention

Active control BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Prisoners
• Severe frailty or physical impairment that prohibits participation in the program
• 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)
• Inability to obtain informed consent ≥2 weeks before scheduled surgery
• Surgical team unwilling to allow physical activity or other components of the intervention
• Inability or unwillingness to utilize a tablet device, laptop, or email
• Co-enrolled in another interventional trial examining similar outcomes or current enrollment in a study that does not allow co-enrollment

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Christopher G Hughes, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Treatment assignment will be known only by the research coordinators, therapists, and research staff overseeing the administration of the program or active control. The remaining research staff, neuropsychology professionals performing the assessments, and clinicians will be blinded. Participants will be blinded to their group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: May 17, 2021
• Study Start: October 12, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)