COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study

Not Applicable

Completed

• Conditions: Cognitive Impairment; Physical Impairment; Postoperative Complications
• Interventions: Behavioral: Cognitive and physical prehabilitation; Other: Active attention control

• Registration Number: NCT03094988
• Lead Sponsor: Vanderbilt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-29
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive and physical prehabilitation	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.
Control	Active attention 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.

Primary Outcome Measures

Name	Time	Method
Participation log and diary	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 Outcome Measures

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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States