COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study (COPEiOS)
Primary Purpose
Cognitive Impairment, Disability Physical, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive training program
Active control
Sponsored by
About this trial
This is an interventional prevention trial for Cognitive Impairment
Eligibility Criteria
Inclusion Criteria:
- ≥60 years old
- undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days
Exclusion Criteria:
- 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
- Prisoners
- Severe frailty or physical impairment that prohibits participation in the program
- 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)
- Inability to obtain informed consent ≥2 weeks before scheduled surgery
- Surgical team unwilling to allow physical activity or other components of the intervention
- Inability or unwillingness to utilize a tablet device, laptop, or email
- Co-enrolled in another interventional trial examining similar outcomes or current enrollment in a study that does not allow co-enrollment
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Computerized brain game training and online interactive physical exercise training
Control computer games and online interactive stretching exercises.
Outcomes
Primary Outcome Measures
Global cognition
Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery
Secondary Outcome Measures
Global cognition
Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery
Basic activities of daily living
Katz activities of daily living
Instrumental activities of daily living
Functional activities questionnaire
Depression
Depression Anxiety and Stress Scale (DASS)
Endothelial injury
Plasma biomarker
Blood brain barrier injury
Plasma biomarker
Brain magnetic resonance imaging
Anatomical and functional magnetic resonance imaging of the brain
Full Information
NCT ID
NCT04889417
First Posted
April 1, 2021
Last Updated
April 20, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04889417
Brief Title
COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study
Acronym
COPEiOS
Official Title
COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Disability Physical, Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Treatment assignment will be known only by the research coordinators, therapists, and research staff overseeing the administration of the program or active control. The remaining research staff, neuropsychology professionals performing the assessments, and clinicians will be blinded. Participants will be blinded to their group assignment.
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Computerized brain game training and online interactive physical exercise training
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control computer games and online interactive stretching exercises.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive training program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global cognition
Description
Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery
Time Frame
3 months after discharge
Secondary Outcome Measure Information:
Title
Global cognition
Description
Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery
Time Frame
12 months after discharge
Title
Basic activities of daily living
Description
Katz activities of daily living
Time Frame
3 and 12 months after discharge
Title
Instrumental activities of daily living
Description
Functional activities questionnaire
Time Frame
3 and 12 months after discharge
Title
Depression
Description
Depression Anxiety and Stress Scale (DASS)
Time Frame
3 and 12 months after discharge
Title
Endothelial injury
Description
Plasma biomarker
Time Frame
day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
Title
Blood brain barrier injury
Description
Plasma biomarker
Time Frame
day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
Title
Brain magnetic resonance imaging
Description
Anatomical and functional magnetic resonance imaging of the brain
Time Frame
3 months after discharge
Other Pre-specified Outcome Measures:
Title
Program compliance
Description
Compliance with program, feasibility
Time Frame
before surgery up to 3 months after discharge
Title
Delirium
Description
Confusion assessment method in the ICU
Time Frame
up to 14 days in the hospital
Title
Length of stay
Description
Length of stay in the hospital
Time Frame
through hospital admission, an average of up to 14 days
Title
Discharge location
Description
Home, rehabilitation, skilled nursing facility, hospice
Time Frame
through hospital admission, an average of up to 14 days
Title
Functional status
Description
Duke Activity Status Index
Time Frame
3 and 12 months after discharge
Title
Aerobic exercise capacity
Description
6-minute walk test
Time Frame
3 months after discharge
Title
Chronic Pain
Description
Behavioral Pain Index
Time Frame
3 and 12 months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥60 years old
undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days
Exclusion Criteria:
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
Prisoners
Severe frailty or physical impairment that prohibits participation in the program
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)
Inability to obtain informed consent ≥2 weeks before scheduled surgery
Surgical team unwilling to allow physical activity or other components of the intervention
Inability or unwillingness to utilize a tablet device, laptop, or email
Co-enrolled in another interventional trial examining similar outcomes or current enrollment in a study that does not allow co-enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher G Hughes, MD
Phone
16153436268
Email
christopher.hughes@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher G Hughes, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher G Hughes, MD
Phone
615-343-5860
Email
christopher.hughes@vumc.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
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COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study
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