Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889417
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2021-04-01
Brief Title:
COgnitive and Physical Exercise to Improve Outcomes After Surgery COPE-iOS Study
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
COgnitive and Physical Exercise to Improve Outcomes After Surgery COPE-iOS Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPEiOS
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AG061161-01A1 | NIH | None | httpsreporternihgovquickSearch1R01AG061161-01A1 |