COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study

NCT03094988 | Completed

• 1 other identifier: 161802
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Physical Impairment; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Cognitive assessment

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

• Instrumental activities of daily living

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

• Activities of daily living

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

• Functional exercise capacity

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

• Muscle strength

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

Study Arms (2)

Control

OTHER

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

Cognitive and physical prehabilitation

EXPERIMENTAL

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

Interventions

Cognitive and physical prehabilitation BEHAVIORAL

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

Cognitive and physical prehabilitation

Active attention control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• 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.

  PMID: 33317805 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction; Postoperative Complications

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 29, 2017
• Study Start: March 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

US (1)