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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04889417
The ClinicalTrials.gov registry entry for NCT04889417 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 52,850-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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