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NCT Number: NCT03094988

COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study

Cognitive and functional impairment are debilitating problems for survivors of major surgery. Efforts to modify medical treatments to prevent such impairment are ongoing and may yet yield significant benefits. An area in need of study is whether building patients' cognitive and physical reserve through a prescribed program of cognitive and physical exercise before the physiological insult (a prehabilitation effort) can improve long-term outcomes. Prehabilitation efforts before surgery thus far have focused on preemptive physical therapy to improve post-surgical functional outcomes. No work, however, has been done to attenuate the cognitive decline commonly seen after surgical illness by exercising the brain before the surgical insult. Cognitive prehabilitation is a novel therapeutic approach that applies well-understood techniques derived from brain plasticity research. Our approach is bolstered by data that demonstrate that cognitive training programs are effective and have a very high likelihood of fostering improvement in patient outcomes across a range of populations. It is not yet known if these programs can improve cognitive reserve, allowing patients' minds to better manage the acute stress of surgery and hospitalization. The primary aim of this pilot study is to evaluate the feasibility of cognitive and physical prehabilitation training in adult patients undergoing major non-cardiac surgery who are at risk for postoperative cognitive and functional decline. The secondary aim is to study the effects of cognitive and physical prehabilitation training on cognitive abilities, functional status, and quality of life after surgery.

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Key information

Age range

18 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

  • Adults undergoing major surgery with the likelihood of prolonged hospitalization or critical illness among the following surgical services: general surgery, surgical oncology, otolaryngology, hepatobiliary, thoracic, and vascular surgery

Exclusion criteria

  • Blind, deaf, or unable to speak English, as these conditions would preclude our ability to perform the proposed cognitive and physical program
  • Pregnancy
  • Prisoners
  • Severe frailty or physical impairment that prohibits participation in prehabilitation program
  • Patients with documented dementia or cognitive impairment that precludes ability to self-consent for surgery and study participation
  • Less than 2 weeks from scheduled surgery
  • Patients without home internet access

Treatment and study plan

Cognitive and physical prehabilitation

Behavioral

Participants engage in cognitive and physical training daily for approximately 2-4 weeks prior to surgery.

Active attention control

Other

Participants will be provided with personal health educational materials and access to the control version of cognitive training program.

Primary outcomes

  1. Participation log and diary

    Time frame: From date of randomization to surgery, approximately 4 weeks

    Proportion of eligible days that patients performed the cognitive and physical prehabilitation program, duration of time per day patients spent on each program

Secondary outcomes

  1. Cognitive assessment

    Time frame: Approximately 1 month after surgery at the post-surgical clinic follow-up

    NIH toolbox cognitive battery

  2. Instrumental activities of daily living

    Time frame: Approximately 1 month after surgery at the post-surgical clinic follow-up

    FAQ questionnaire

  3. Activities of daily living

    Time frame: Approximately 1 month after surgery at the post-surgical clinic follow-up

    ADL questionnaire

  4. Functional exercise capacity

    Time frame: Approximately 1 month after surgery at the post-surgical clinic follow-up

    2 min walk test

  5. Muscle strength

    Time frame: Approximately 1 month after surgery at the post-surgical clinic follow-up

    Hand grip strength

  6. Pulmonary function

    Time frame: Approximately 1 month after surgery at the post-surgical clinic follow-up

    Incentive spirometry

  7. Acute brain dysfunction

    Time frame: During hospital stay after surgery, for up to 2 weeks

    Delirium

  8. Discharge location

    Time frame: From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days

    Determination of location where patient was discharged from hospital to, including home, nursing facility, rehab

  9. Pain levels

    Time frame: During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up

    CPOT

  10. Pain levels

    Time frame: During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up

    NRS

  11. Hospital length of stay

    Time frame: From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days

    Duration of hospital stay

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

COgnitive and Physical Exercise (COPE) Prehabilitation to Improve Outcomes in Surgical Patients: A Pilot Feasibility Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2017
Registry last updated
Jan 14, 2021

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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