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Search / Trial NCT04889417

COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · May 11, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The COPE-iOS study is looking at how a program that combines brain training and physical exercise can help older patients recover better after surgery. Researchers want to see if this program can improve thinking skills and reduce disability in patients aged 60 and older who are having major surgery and are at risk of cognitive decline. The study will involve 250 participants who will either take part in the training program or engage in a control group with different activities for a few weeks before their surgery and for three months after they go home.

To qualify for the study, participants must be at least 60 years old and scheduled for a major surgery that requires a hospital stay of three days or more. Unfortunately, those who are unable to understand English, have severe physical limitations, or are currently in other similar studies cannot participate. Throughout the study, researchers will assess various aspects of the participants' mental and physical health to see how well the training program works. This research aims to find out which patients benefit the most and how different parts of the program affect recovery.

Gender

ALL

Eligibility 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

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.

Locations

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Christopher G Hughes, MD

Principal Investigator

Vanderbilt University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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