COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Cognitive Impairment, Physical Impairment, Postoperative Complications

Intervention / Treatment
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* Behavioral: Cognitive and physical prehabilitation
* Other: Active attention control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>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<br>* Participants will be provided with personal health educational materials and access to the control version of cognitive training program.<br>|
| Experimental: Cognitive and physical prehabilitation<br>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<br>* Participants engage in cognitive and physical training daily for approximately 2-4 weeks prior to surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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