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Active, Not Recruiting

NCT Number: NCT04889417

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Disability Physical Mental Disorders Neurocognitive Disorders Surgery

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥60 years old
  • undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days

Exclusion criteria

  • 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
  • Prisoners
  • 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)
  • Inability to obtain informed consent ≥2 weeks before scheduled surgery
  • Surgical team unwilling to allow physical activity or other components of the intervention
  • Inability or unwillingness to utilize a tablet device, laptop, or email
  • Co-enrolled in another interventional trial examining similar outcomes or current enrollment in a study that does not allow co-enrollment

Treatment and study plan

Comprehensive training program

Behavioral

The COPE-iOS program is a pragmatic comprehensive training program that combines computerized cognitive training and progressive supervised video conference physical exercise sessions performed 2-4 weeks prior to surgery and for 3 months after discharge.

Active Control

Behavioral

The active attention control will include control computer games and supervised video conference stretching exercises performed 2-4 weeks prior to surgery and for 3 months after discharge.

Primary outcomes

  1. Global cognition

    Time frame: 3 months after discharge

    Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery

Secondary outcomes

  1. Global cognition

    Time frame: 12 months after discharge

    Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery

  2. Basic activities of daily living

    Time frame: 3 and 12 months after discharge

    Katz activities of daily living

  3. Instrumental activities of daily living

    Time frame: 3 and 12 months after discharge

    Functional activities questionnaire

  4. Depression

    Time frame: 3 and 12 months after discharge

    Depression Anxiety and Stress Scale (DASS)

  5. Endothelial injury

    Time frame: day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge

    Plasma biomarker

  6. Blood brain barrier injury

    Time frame: day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge

    Plasma biomarker

  7. Brain magnetic resonance imaging

    Time frame: 3 months after discharge

    Anatomical and functional magnetic resonance imaging of the brain

Other outcomes

  1. Program compliance

    Time frame: before surgery up to 3 months after discharge

    Compliance with program, feasibility, including sessions attended and completed, heart rate and exertion tracking during session

  2. Delirium

    Time frame: up to 14 days in the hospital

    Confusion assessment method in the ICU

  3. Length of stay

    Time frame: through hospital admission, an average of up to 14 days

    Length of stay in the hospital

  4. Discharge location

    Time frame: through hospital admission, an average of up to 14 days

    Home, rehabilitation, skilled nursing facility, hospice

  5. Functional status

    Time frame: 3 and 12 months after discharge

    Duke Activity Status Index

  6. Chronic Pain

    Time frame: 3 and 12 months after discharge

    Behavioral Pain Index

  7. Adverse events

    Time frame: before surgery up to 3 months after discharge

    Safety evaluated by adverse event monitoring, including physical injury (e.g., discomfort, falls, myocardial ischemia, syncope, dyspnea), above maximum heart rate, and fatigue

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: COPEiOS

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
May 17, 2021
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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