← Back to Search

Comprehensive Training Program for Surgery Recovery (COPEiOS Trial)

N/A
Recruiting
Led By Christopher G Hughes, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days
≥60 years old
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after discharge
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a combination of computerized cognitive training and physical exercise before and after surgery can improve long-term cognitive and disability outcomes in older surgical patients.

Who is the study for?
The COPE-iOS study is for individuals aged 60 or older who are scheduled for elective major non-cardiac surgery with a hospital stay of at least 3 days. Participants must be able to consent, use a tablet or laptop, and understand English. Those with severe frailty, cognitive impairment preventing self-consent, or enrolled in similar trials cannot join.
What is being tested?
This trial tests if combining computerized brain exercises and physical training before and after surgery can improve long-term mental function and reduce disability in older patients. Half will receive the comprehensive program while the other half gets control activities like simple games and stretching.
What are the potential side effects?
Since this trial involves cognitive and physical exercises rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue but are expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a major surgery that is not heart-related and will be in the hospital for 3 or more days.
Select...
I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am too frail or physically impaired to participate in the program.
Select...
I am able to understand and consent to surgery on my own.
Select...
My surgical team does not approve of me participating in physical activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Basic activities of daily living
Blood brain barrier injury
Brain magnetic resonance imaging
+4 more
Other study objectives
Aerobic exercise capacity
Chronic Pain
Delirium
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Computerized brain game training and online interactive physical exercise training
Group II: ControlActive Control1 Intervention
Control computer games and online interactive stretching exercises.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
908 Previous Clinical Trials
934,590 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,805 Previous Clinical Trials
28,194,607 Total Patients Enrolled
Christopher G Hughes, MDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Active control Clinical Trial Eligibility Overview. Trial Name: NCT04889417 — N/A
Cognitive Impairment Research Study Groups: Intervention, Control
Cognitive Impairment Clinical Trial 2023: Active control Highlights & Side Effects. Trial Name: NCT04889417 — N/A
Active control 2023 Treatment Timeline for Medical Study. Trial Name: NCT04889417 — N/A
~83 spots leftby Jul 2026