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NCT04889417 · ClinicalTrials.gov registry record · NA
COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study
A NA study of Surgery and Cognitive Impairment, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT04889417: Active NA study of Surgery and Cognitive Impairment, sponsored by Vanderbilt University Medical Center.
NCT04889417 is a NA study of Surgery and Cognitive Impairment that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 250 participants, below the 52,850-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04889417, a NA study of Surgery and Cognitive Impairment, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery
Conditions Studied
Interventions
- BEHAVIORAL Active control
- BEHAVIORAL Comprehensive training program
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2021-10-12 |
| Est. Completion | 2027-07-01 |
| Phase | NA |
What the registry record for NCT04889417 still lists
NCT04889417 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 52,850-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Surgery appearing as the primary indexed condition, and to 2 interventions - of which Active control is the first listed.
NCT04889417 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04889417 about?
NCT04889417 is a clinical study titled "COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study". 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 ol...
What is the current status of trial NCT04889417?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2021-10-12. Estimated completion is 2027-07-01.
What conditions does trial NCT04889417 study?
This clinical trial studies the following conditions: Surgery, Cognitive Impairment, Disability Physical.
What interventions are being tested in trial NCT04889417?
The interventions under investigation include: Active control (BEHAVIORAL), Comprehensive training program (BEHAVIORAL).
Who is sponsoring clinical trial NCT04889417?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04889417 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04889417's enrollment target sits among peer trials
250 35th of 120 higher than 85 of 120 other Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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