Cognitive ImpairmentCOPEiOSNCT04889417
COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study
A study testing Comprehensive training program in people with Cognitive Impairment and Disability Physical, run by Vanderbilt University Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment, Disability Physical, Surgery
- What is being tested?
- Comprehensive training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥60 years old
- undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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.
- Conditions
- Cognitive Impairment, Disability Physical, Surgery
- Being tested
- Comprehensive training program, Active control
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive training programBehavioural
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 controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Computerized brain game training and online interactive physical exercise training Receives: Behavioral: Comprehensive training program |
| Control | Active comparator | Control computer games and online interactive stretching exercises. Receives: Behavioral: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognition
Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery
Measured: 3 months after discharge
Secondary outcomes (7)
Global cognition
Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery
Measured: 12 months after discharge
Basic activities of daily living
Katz activities of daily living
Measured: 3 and 12 months after discharge
Instrumental activities of daily living
Functional activities questionnaire
Measured: 3 and 12 months after discharge
Depression
Depression Anxiety and Stress Scale (DASS)
Measured: 3 and 12 months after discharge
Endothelial injury
Plasma biomarker
Measured: day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
Blood brain barrier injury
Plasma biomarker
Measured: day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
Brain magnetic resonance imaging
Anatomical and functional magnetic resonance imaging of the brain
Measured: 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start12 Oct 2021
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Christopher G Hughes, Vanderbilt University Medical Center
- Investigators
- Christopher G Hughes, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889417
- Sponsor's protocol ID
- U11775
- Other IDs
- 1R01AG061161-01A1
- Acronym
- COPEiOS
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Rengel KF, Archer KR, Jackson JC, Raman R, Orun OM, Ellison T, Vanston SW, Ervin H, Lauck A, Provin M, Pandharipande PP, Hughes CG. Cognitive and physical exercise to improve outcomes after surgery (COPE-iOS) study: protocol for a randomised, controlled trial in the USA examining the efficacy of a combined cognitive and physical exercise programme performed before and after major surgery in improving cognitive and functional outcomes for older adults. BMJ Open. 2026 Feb 12;16(2):e110435. doi: 10.1136/bmjopen-2025-110435.
PubMed 41688121