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

Study acronym: COPEiOS
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Oct 31, 2026 → Jan 31, 2027
See other at-risk trials from Vanderbilt University Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion pushed from Oct 31, 2026 to Jan 31, 2027
    • Eligibility criteria expanded, about 10 words
    • Publications: details revised at 1 of 1 entry
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jul 31, 2026 to Oct 31, 2026
    • Site details revised
    v11
  3. Minor 2 versions Re-verified since Apr 29, 2024, no change to tracked fieldsv9-v10
  4. Minor Secondary endpoints: details revised at 1 of 7 entriesv8
  5. Minor Re-verified, no change to tracked fieldsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Primary completion date: Jun 2026 to Jul 31, 2026
    • Study completion date: Jun 2026 to Jul 1, 2027
    v6
  2. Minor Collaborators expanded, about 5 wordsv5
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 1, 2021 to Oct 12, 2021
    v4
  4. Notable Start date: Sep 1, 2021 to Nov 1, 2021v3
  5. Notable Start date: Jun 1, 2021 to Sep 1, 2021v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04889417
Lead Sponsor Vanderbilt University Medical Center
Collaborators: National Institute on Aging (NIA)
Conditions
(from sponsor)
Cognitive Impairment, Disability Physical, Surgery
Related terms Cognitive Dysfunction
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov