Clinical trial NCT03094988: COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study
Official title: COgnitive and Physical Exercise (COPE) Prehabilitation to Improve Outcomes in Surgical Patients: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Physical Impairment
Postoperative Complications
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Participation log and diary
timeFrame: From date of randomization to surgery, approximately 4 weeks
Secondary outcomes:
measure: Cognitive assessment
timeFrame: Approximately 1 month after surgery at the post-surgical clinic follow-up
measure: Instrumental activities of daily living
timeFrame: Approximately 1 month after surgery at the post-surgical clinic follow-up
measure: Activities of daily living
timeFrame: Approximately 1 month after surgery at the post-surgical clinic follow-up
measure: Functional exercise capacity
timeFrame: Approximately 1 month after surgery at the post-surgical clinic follow-up
measure: Muscle strength
timeFrame: Approximately 1 month after surgery at the post-surgical clinic follow-up
measure: Pulmonary function
timeFrame: Approximately 1 month after surgery at the post-surgical clinic follow-up
measure: Acute brain dysfunction
timeFrame: During hospital stay after surgery, for up to 2 weeks
measure: Discharge location
timeFrame: From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days
measure: Pain levels
timeFrame: During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up
measure: Pain levels
timeFrame: During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up
measure: Hospital length of stay
timeFrame: From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
citation: Rengel KF, Mehdiratta N, Vanston SW, Archer KR, Jackson JC, Thompson JL, Pandharipande PP, Hughes CG. A randomised pilot trial of combined cognitive and physical exercise prehabilitation to improve outcomes in surgical patients. Br J Anaesth. 2021 Feb;126(2):e55-e57. doi: 10.1016/j.bja.2020.11.004. Epub 2020 Dec 13. No abstract available.