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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
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 moreOther study objectives
Aerobic exercise capacity
Chronic Pain
Delirium
+4 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am too frail or physically impaired to participate in the program.I am able to understand and consent to surgery on my own.I am scheduled for a major surgery that is not heart-related and will be in the hospital for 3 or more days.I am 60 years old or older.I was unable to give informed consent at least 2 weeks before my scheduled surgery.My surgical team does not approve of me participating in physical activities.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.