COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study

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

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Cognitive Impairment; Physical Impairment
• Intervention / Treatment: Other: Active attention control; Behavioral: Cognitive and physical prehabilitation

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Control; The active attention control group will receive a binder with information about personal health including sleep hygiene, nutritional changes, and stress reduction. In addition, they will participate in a control version of the cognitive training program. They will receive weekly phone calls by cognitive and physical therapy teams to address issues with any aspects of the program.	Other: Active attention control; Participants will be provided with personal health educational materials and access to the control version of cognitive training program.
EXPERIMENTAL: Cognitive and physical prehabilitation; The intervention group will receive the prehabilitation program consisting of a guided progressive program of home-based aerobic and resistance training exercise, which will be adapted based on kinesiologist recommendation for each individual and the individual's perceived exertion. In addition, they will have access to the full cognitive training program. They will receive weekly phone calls by cognitive and physical therapy teams to address issues with any aspects of the program.	Behavioral: Cognitive and physical prehabilitation; Participants engage in cognitive and physical training daily for approximately 2-4 weeks prior to surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation log and diary	Proportion of eligible days that patients performed the cognitive and physical prehabilitation program, duration of time per day patients spent on each program	From date of randomization to surgery, approximately 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive assessment	NIH toolbox cognitive battery	Approximately 1 month after surgery at the post-surgical clinic follow-up
Instrumental activities of daily living	FAQ questionnaire	Approximately 1 month after surgery at the post-surgical clinic follow-up
Activities of daily living	ADL questionnaire	Approximately 1 month after surgery at the post-surgical clinic follow-up
Functional exercise capacity	2 min walk test	Approximately 1 month after surgery at the post-surgical clinic follow-up
Muscle strength	Hand grip strength	Approximately 1 month after surgery at the post-surgical clinic follow-up
Pulmonary function	Incentive spirometry	Approximately 1 month after surgery at the post-surgical clinic follow-up
Acute brain dysfunction	Delirium	During hospital stay after surgery, for up to 2 weeks
Discharge location	Determination of location where patient was discharged from hospital to, including home, nursing facility, rehab	From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days
Pain levels	CPOT	During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up
Pain levels	NRS	During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up
Hospital length of stay	Duration of hospital stay	From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days

Collaborators and Investigators

• Sponsor: Vanderbilt University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (ACTUAL): March 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 161802

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No