Cognitive Impairment, Physical Impairment, Postoperative Complications
Conditions
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.
Interventions
BEHAVIORALCognitive and physical prehabilitation
Participants engage in cognitive and physical training daily for approximately 2-4 weeks prior to surgery.
Participants will be provided with personal health educational materials and access to the control version of cognitive training program.
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation log and diary | From date of randomization to surgery, approximately 4 weeks | Proportion of eligible days that patients performed the cognitive and physical prehabilitation program, duration of time per day patients spent on each program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Instrumental activities of daily living | Approximately 1 month after surgery at the post-surgical clinic follow-up | FAQ questionnaire |
| Activities of daily living | Approximately 1 month after surgery at the post-surgical clinic follow-up | ADL questionnaire |
| Functional exercise capacity | Approximately 1 month after surgery at the post-surgical clinic follow-up | 2 min walk test |
| Muscle strength | Approximately 1 month after surgery at the post-surgical clinic follow-up | Hand grip strength |
| Cognitive assessment | Approximately 1 month after surgery at the post-surgical clinic follow-up | NIH toolbox cognitive battery |
| Acute brain dysfunction | During hospital stay after surgery, for up to 2 weeks | Delirium |
| Discharge location | From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days | Determination of location where patient was discharged from hospital to, including home, nursing facility, rehab |
| Pain levels | During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up | CPOT |
| Hospital length of stay | From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days | Duration of hospital stay |
| Pulmonary function | Approximately 1 month after surgery at the post-surgical clinic follow-up | Incentive spirometry |
Countries
United States
Outcome results
None listed