Postoperative Delirium and Delayed Functional Recovery
Conditions
Keywords
aerobic exercise training, delirium
Brief summary
This is a randomized study to examine whether aerobic exercise training (AET) before total shoulder replacement (TSR) surgery reduces the incidence of post-operative delirium (POD) and shorten time to recovery in elderly patients. POD is a form of sudden change in mental function that can be experienced after undergoing surgery.
Detailed description
This randomized clinical trial will determine whether aerobic exercise training (AET) before total shoulder replacement (TSR) surgery reduces the incidence of post-operative delirium (POD) and shortens time to recovery in elderly patients. Delayed recovery affects up to 30% of surgical patients and imposes enormous costs on patients, caregivers, and society. Patients over 65 are four times more likely to experience POD, a form of sudden change in mental function that could be experienced after undergoing surgery. POD is associated with impaired daily functioning, longer hospital stay, more frequent institutionalization, and increased mortality. Prevention of POD is a high clinical priority. Evidence suggests that an exaggerated inflammatory response contributes to POD. Human studies show that AET may exert anti-inflammatory effects. Furthermore, recent animal data show that AET attenuates the inflammatory response to surgery and prevents associated cognitive dysfunction. The trial will enroll elderly patients undergoing TSR surgery to examine whether a low-cost intervention before surgery can improve clinical outcomes (reduction in POD and decrease recovery time). The effects of a 4-week AET program, specifically a type known as high-intensity interval training (HIIT), on the incidence of POD and time to recovery from fatigue and functional impairment. We will also analyze patients' immune state before and after surgery with modern techniques (high-dimensional mass cytometry). Understanding the immune-modulatory effects of AET will reveal mechanisms that can be targeted by interventions other than or in addition to exercise, which may benefit patients who are physically disabled or require urgent surgery, and help identify non-surgical diseases that may benefit from exercise.
Interventions
BEHAVIORALAerobic Exercise Training (AET)
20 sessions of AET over a 4 week period just prior to surgery
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients scheduled for total shoulder replacement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function after surgery | up to hospital discharge (approximately 1 day) | Cognition will be assessed using the Nursing Delirium Screen (NU-DESC) scale to determine if there is any change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Recovery after surgery | up to 12 weeks post-operatively | Functional recovery will be assessed with the Surgery Recovery Scale (SRS).The SRS sensitively and reliably captures changes in individual patients, which allows construction of patient-specific recovery trajectories |
| CyTOF of blood samples | Before exercise (approximately 4 weeks before surgery), after exercise (on the morning of surgery), and 1 hour, 6 hours, and 24 hours post-surgery. | Blood samples will be collected prior to the intervention, prior to and after surgery for high dimensional mass cytometry |
Countries
United States
Outcome results
None listed