NCT03094988

COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study

Completed NA Last updated 14 January 2021

What this trial tests

NA trial testing Cognitive and physical prehabilitation in Cognitive Impairment in 32 participants. Completed in 1 September 2018.

Timeline

1 March 2017

Primary endpoint
1 September 2018

1 September 2018

Quick facts

Lead sponsor	Vanderbilt University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	32
Start date	1 March 2017
Primary completion	1 September 2018
Estimated completion	1 September 2018
Sites	1 location across United States

Drugs / interventions tested

• Cognitive and physical prehabilitation
• Active attention control

Conditions studied

• Cognitive Impairment — all drugs for Cognitive Impairment →
• Physical Impairment — all drugs for Physical Impairment →
• Postoperative Complications — all drugs for Postoperative Complications →

Sponsor

Vanderbilt University

Who can join

18 and older, any sex, with Cognitive Impairment or Physical Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomised pilot trial of combined cognitive and physical exercise prehabilitation to improve outcomes in surgical patients.
   Rengel KF, Mehdiratta N, Vanston SW, Archer KR, et al · · 2021 · cited 13× · PMID 33317805 · DOI 10.1016/j.bja.2020.11.004