COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study (COPEiOS)

Vanderbilt University Medical Center

Status: Active, not recruiting

Conditions: Cognitive Impairment; Surgery; Disability Physical

Treatments: Behavioral: Active control; Behavioral: Comprehensive training program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04889417

U11775

1R01AG061161-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 2 patient groups

Intervention

Experimental group

Description:

Computerized brain game training and online interactive physical exercise training

Treatment:

Behavioral: Comprehensive training program

Control

Active Comparator group

Description:

Control computer games and online interactive stretching exercises.

Treatment:

Behavioral: Active control