COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study

Vanderbilt University

Status: Completed

Conditions: Postoperative Complications; Cognitive Impairment; Physical Impairment

Treatments: Other: Active attention control; Behavioral: Cognitive and physical prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03094988

161802

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Control

Other group

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.

Treatment:

Other: Active attention control

Cognitive and physical prehabilitation

Experimental group

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.

Treatment:

Behavioral: Cognitive and physical prehabilitation