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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04889417
Other study ID # U11775
Secondary ID 1R01AG061161-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date October 12, 2021
Est. completion date July 1, 2027

Study information

Verified date April 2024
Source Vanderbilt University Medical Center
Contact Christopher G Hughes, MD
Phone 16153436268
Email christopher.hughes@vumc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date July 1, 2027
Est. primary completion date July 31, 2026
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: 1. =60 years old 2. undergoing elective major non-cardiac surgery with expected hospitalization =3 days Exclusion Criteria: 1. Blind, deaf, or inability to understand English as these conditions would preclude the ability to perform the proposed comprehensive program and prevent assessment with the study instruments 2. Prisoners 3. Severe frailty or physical impairment that prohibits participation in the program 4. Cognitively unable to consent for surgery (i.e., dementia or cognitive impairment of a severity that precludes ability to self-consent and, thus, also participation in study interventions) 5. Inability to obtain informed consent =2 weeks before scheduled surgery 6. Surgical team unwilling to allow physical activity or other components of the intervention 7. Inability or unwillingness to utilize a tablet device, laptop, or email 8. Co-enrolled in another interventional trial examining similar outcomes or current enrollment in a study that does not allow co-enrollment

Study Design


Intervention

Behavioral:
Comprehensive training program
The COPE-iOS program is a pragmatic comprehensive training program that combines computerized cognitive training and progressive supervised video conference physical exercise sessions performed 2-4 weeks prior to surgery and for 3 months after discharge.
Active control
The active attention control will include control computer games and supervised video conference stretching exercises performed 2-4 weeks prior to surgery and for 3 months after discharge.

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Medical Center National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Program compliance Compliance with program, feasibility before surgery up to 3 months after discharge
Other Delirium Confusion assessment method in the ICU up to 14 days in the hospital
Other Length of stay Length of stay in the hospital through hospital admission, an average of up to 14 days
Other Discharge location Home, rehabilitation, skilled nursing facility, hospice through hospital admission, an average of up to 14 days
Other Functional status Duke Activity Status Index 3 and 12 months after discharge
Other Aerobic exercise capacity 6-minute walk test 3 months after discharge
Other Chronic Pain Behavioral Pain Index 3 and 12 months after discharge
Primary Global cognition Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery 3 months after discharge
Secondary Global cognition Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery 12 months after discharge
Secondary Basic activities of daily living Katz activities of daily living 3 and 12 months after discharge
Secondary Instrumental activities of daily living Functional activities questionnaire 3 and 12 months after discharge
Secondary Depression Depression Anxiety and Stress Scale (DASS) 3 and 12 months after discharge
Secondary Endothelial injury Plasma biomarker day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
Secondary Blood brain barrier injury Plasma biomarker day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
Secondary Brain magnetic resonance imaging Anatomical and functional magnetic resonance imaging of the brain 3 months after discharge
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