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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after discharge
Awards & highlights
COPEiOS Trial 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.Check my eligibility
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.See study design
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.
COPEiOS Trial 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.
COPEiOS Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Basic activities of daily living
Blood brain barrier injury
Brain magnetic resonance imaging
+4 moreOther outcome measures
Aerobic exercise capacity
Chronic Pain
Delirium
+4 moreCOPEiOS 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.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
861 Previous Clinical Trials
672,553 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,684 Previous Clinical Trials
28,025,591 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are eligible to participate in this research endeavor?
"Affirmative. Clinicaltrials.gov has evidence that this investigation is actively seeking out participants; the protocol was first unveiled on December 10th 2021 and revised February 2nd 2022. The researchers require 250 volunteers from a single site to take part in their findings."
Answered by AI
Does this research endeavor accept new participants?
"Clinicaltrials.gov currently lists this experiment as actively recruiting participants, having opened recruitment on October 12th 2021 and last edited the listing on February 2nd 2022."
Answered by AI
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