Cognitive and physical exercise program for older surgical patients
COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study
This study is testing if a program that combines brain training and physical exercise can help older patients recover better after major surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT04889417 on ClinicalTrials.gov |
What this trial studies
The COPE-iOS study investigates whether a combined program of computerized cognitive training and physical exercise can enhance cognitive and functional outcomes in older patients undergoing major non-cardiac surgery. This randomized trial will involve 250 participants aged 60 and above, who will either engage in the comprehensive training program or an active control group for 2-4 weeks before surgery and for three months post-discharge. Assessments will include evaluations of cognition, daily living activities, depression, and neuroimaging to measure the impact of the interventions.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 and older who are scheduled for elective major non-cardiac surgery with a hospitalization expectation of three days or more.
Not a fit: Patients who are severely frail, cognitively impaired, or unable to participate in the program due to physical limitations will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve cognitive function and reduce disability in older adults after surgery.
How similar studies have performed: While the approach of combining cognitive and physical training is promising, it is relatively novel and has not been extensively tested in this specific surgical context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Christopher G Hughes, MD — Vanderbilt University Medical Center
- Study coordinator: Christopher G Hughes, MD
- Email: christopher.hughes@vumc.org
- Phone: 16153436268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.