ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is testing the hypothesis that a pragmatic program combining computerized cognitive training and physical training throughout the perioperative period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. To accomplish these goals, the Investigators are randomizing 250 patients ≥60 years old undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days to a pragmatic comprehensive training program (computerized cognitive training and supervised progressive physical exercise) or to active control (control computer game, stretching exercises) for 2-4 weeks prior to surgery and for 3 months after discharge. At baseline and after discharge, the Investigators will assess global cognition, activities of daily living, depression, endothelial and blood brain barrier function (blood biomarkers), and neuroimaging (anatomical and functional MRI). In this early stage trial, the Investigators will determine if certain subgroups benefit most, program aspects with greatest effect on outcomes, mechanistic associations with outcomes, and additional exploratory analyses.

Official Title

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

Quick Facts

Study Start:2021-10-12
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04889417

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥60 years old
  2. 2. undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days
  1. 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. 2. Prisoners
  3. 3. Severe frailty or physical impairment that prohibits participation in the program
  4. 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. 5. Inability to obtain informed consent ≥2 weeks before scheduled surgery
  6. 6. Surgical team unwilling to allow physical activity or other components of the intervention
  7. 7. Inability or unwillingness to utilize a tablet device, laptop, or email
  8. 8. Co-enrolled in another interventional trial examining similar outcomes or current enrollment in a study that does not allow co-enrollment

Contacts and Locations

Principal Investigator

Christopher G Hughes, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37212
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Christopher G Hughes, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-12
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2021-10-12
Study Completion Date2027-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cognitive Impairment
  • Disability Physical
  • Surgery