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

R
Roman Natoli, MD

Primary Investigator

Enrolling By Invitation
60 years or above
All
Phase N/A
250 participants needed
1 Location

Brief description of study

What is the purpose of this study?
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. 
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients will be identified during morning conference at IU Health Methodist Hospital where we go through all patients on the orthopaedic trauma service with the surgeons and advanced practice providers. Patients with qualifying injuries will be flagged as potential candidates and further medical record review will be conducted by the study team.

Detailed description of study

What will happen during the study?
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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cognitive Impairment, Physical disability
  • Age: 60 years or above
  • Gender: All

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 thebility to perform the proposed comprehensive program and prevent assessment with theudy 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 averity that precludes ability to self-consent and, thus, also participation in studyventions)
  5. Inability to obtain informed consent ≥2 weeks before scheduled surgery
  6. Surgical team unwilling to allow physical activity or other components of thevention
  7. Inability or unwillingness to utilize a tablet device, laptop, or email
  8. Co-enrolled in another interventional trial examining similar outcomes or currentudy that does not allow co-enrollment

Updated on 26 Feb 2025. Study ID: U11775, ORTHO-MCMASTER-COPE, 13592
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