Clinical trial NCT04889417: COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study
Official title: COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Disability Physical
Surgery
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-05-17
Enrollment: 250
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Global cognition
timeFrame: 3 months after discharge
Secondary outcomes:
measure: Global cognition
timeFrame: 12 months after discharge
measure: Basic activities of daily living
timeFrame: 3 and 12 months after discharge
measure: Instrumental activities of daily living
timeFrame: 3 and 12 months after discharge
measure: Depression
timeFrame: 3 and 12 months after discharge
measure: Endothelial injury
timeFrame: day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
measure: Blood brain barrier injury
timeFrame: day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
measure: Brain magnetic resonance imaging
timeFrame: 3 months after discharge
Other outcomes:
measure: Program compliance
timeFrame: before surgery up to 3 months after discharge
measure: Delirium
timeFrame: up to 14 days in the hospital
measure: Length of stay
timeFrame: through hospital admission, an average of up to 14 days
measure: Discharge location
timeFrame: through hospital admission, an average of up to 14 days
measure: Functional status
timeFrame: 3 and 12 months after discharge
measure: Aerobic exercise capacity
timeFrame: 3 months after discharge
measure: Chronic Pain
timeFrame: 3 and 12 months after discharge
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Christopher G Hughes, MD
role: PRINCIPAL_INVESTIGATOR
References: