COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094988
• Other study ID #: 161802
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: January 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Impairment
• Physical Impairment
• Postoperative Complications

Intervention

Behavioral:
• Cognitive and physical prehabilitation
Participants engage in cognitive and physical training daily for approximately 2-4 weeks prior to surgery.

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & 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. 2020 Dec 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cognitive assessment	NIH toolbox cognitive battery	Approximately 1 month after surgery at the post-surgical clinic follow-up
Secondary	Instrumental activities of daily living	FAQ questionnaire	Approximately 1 month after surgery at the post-surgical clinic follow-up
Secondary	Activities of daily living	ADL questionnaire	Approximately 1 month after surgery at the post-surgical clinic follow-up
Secondary	Functional exercise capacity	2 min walk test	Approximately 1 month after surgery at the post-surgical clinic follow-up
Secondary	Muscle strength	Hand grip strength	Approximately 1 month after surgery at the post-surgical clinic follow-up
Secondary	Pulmonary function	Incentive spirometry	Approximately 1 month after surgery at the post-surgical clinic follow-up
Secondary	Acute brain dysfunction	Delirium	During hospital stay after surgery, for up to 2 weeks
Secondary	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
Secondary	Pain levels	CPOT	During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up
Secondary	Pain levels	NRS	During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up
Secondary	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