Status:
COMPLETED
Perioperative Cognitive Protection - Cognitive Exercise and Cognitive Reserve (The Neurobics Trial)
Lead Sponsor:
Ohio State University
Conditions:
Delirium
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
Many individuals experience an acute change in thinking and reasoning skills after surgery. This is called post-operative delirium (PD). PD symptoms typically start 1-3 days after surgery. Advanced ag...
Detailed Description
Potential study participants will be identified one of two ways, either by the treating physician in clinic when the decision is made to pursue surgery or by researchers monitoring the OR schedule. Wh...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 60 years of age or older
- Capable and willing to consent
- Non-cardiac/non-neurological surgery with expected hospital stay of at least 72 H
- American Society of Anesthesiologists (ASA) physical status I-IV
- English speaking
- Willingness to use a provided tablet device
- Willingness to commit at least 1 hour per day to experimental intervention (cognitive activity/exercise) to complete a minimum of 10 hours within at least 8 days prior to surgery.
- Exclusion criteria
- Severe visual or auditory deficits
- Illiterate
- Surgery within the previous 6 months requiring general anesthesia
- Score \< 26 on initial Mini Mental Status Exam (MMSE - modified version) (24 for patients with less than high school education)
- Positive pre-surgery Confusion Assessment Method test (CAM)
- Active depression as indicated by Geriatric Depression Scale screening test (score ≥ 10)
- History of Axis I or II psychiatric disorders including bipolar disorder, schizophrenia, dementia, alcohol or drug abuse
- ASA physical status V, VI
- Planned postoperative intubation
Exclusion
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2019
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT02230605
Start Date
July 1 2015
End Date
August 20 2019
Last Update
September 11 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210