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COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study

Primary Purpose

Cognitive Impairment, Physical Impairment, Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive and physical prehabilitation
Active attention control
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Cognitive and physical prehabilitation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cognitive assessment
NIH toolbox cognitive battery
Instrumental activities of daily living
FAQ questionnaire
Activities of daily living
ADL questionnaire
Functional exercise capacity
2 min walk test
Muscle strength
Hand grip strength
Pulmonary function
Incentive spirometry
Acute brain dysfunction
Delirium
Discharge location
Determination of location where patient was discharged from hospital to, including home, nursing facility, rehab
Pain levels
CPOT
Pain levels
NRS
Hospital length of stay
Duration of hospital stay

Full Information

First Posted
March 6, 2017
Last Updated
January 11, 2021
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT03094988
Brief Title
COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study
Official Title
COgnitive and Physical Exercise (COPE) Prehabilitation to Improve Outcomes in Surgical Patients: A Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Physical Impairment, Postoperative Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
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.
Arm Title
Cognitive and physical prehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive and physical prehabilitation
Intervention Description
Participants engage in cognitive and physical training daily for approximately 2-4 weeks prior to surgery.
Intervention Type
Other
Intervention Name(s)
Active attention control
Intervention Description
Participants will be provided with personal health educational materials and access to the control version of cognitive training program.
Primary Outcome Measure Information:
Title
Participation log and diary
Description
Proportion of eligible days that patients performed the cognitive and physical prehabilitation program, duration of time per day patients spent on each program
Time Frame
From date of randomization to surgery, approximately 4 weeks
Secondary Outcome Measure Information:
Title
Cognitive assessment
Description
NIH toolbox cognitive battery
Time Frame
Approximately 1 month after surgery at the post-surgical clinic follow-up
Title
Instrumental activities of daily living
Description
FAQ questionnaire
Time Frame
Approximately 1 month after surgery at the post-surgical clinic follow-up
Title
Activities of daily living
Description
ADL questionnaire
Time Frame
Approximately 1 month after surgery at the post-surgical clinic follow-up
Title
Functional exercise capacity
Description
2 min walk test
Time Frame
Approximately 1 month after surgery at the post-surgical clinic follow-up
Title
Muscle strength
Description
Hand grip strength
Time Frame
Approximately 1 month after surgery at the post-surgical clinic follow-up
Title
Pulmonary function
Description
Incentive spirometry
Time Frame
Approximately 1 month after surgery at the post-surgical clinic follow-up
Title
Acute brain dysfunction
Description
Delirium
Time Frame
During hospital stay after surgery, for up to 2 weeks
Title
Discharge location
Description
Determination of location where patient was discharged from hospital to, including home, nursing facility, rehab
Time Frame
From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days
Title
Pain levels
Description
CPOT
Time Frame
During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up
Title
Pain levels
Description
NRS
Time Frame
During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up
Title
Hospital length of stay
Description
Duration of hospital stay
Time Frame
From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33317805
Citation
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.
Results Reference
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COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study

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