COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study

NCT ID: NCT03094988

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Active attention control

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Cognitive and physical prehabilitation

Intervention Type: BEHAVIORAL

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

Interventions

Cognitive and physical prehabilitation

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

Intervention Type: BEHAVIORAL

Active attention control

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Hughes

Associate Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 33317805 (View on PubMed)

Other Identifiers

161802

Identifier Type: -

Identifier Source: org_study_id