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TSA Exercise Prehabilitation in Older Adults

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Terminated

Conditions

Postoperative Delirium and Delayed Functional Recovery

Treatments

Behavioral: Aerobic Exercise Training (AET)

Study type

Interventional

Funder types

Other

Identifiers

NCT03212300
1620740

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

55 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Patients scheduled for total shoulder replacement

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

3 participants in 2 patient groups

Aerobic Exercise Training (AET)
Active Comparator group
Description:
20 sessions of AET over a 4 week period just prior to surgery
Treatment:
Behavioral: Aerobic Exercise Training (AET)
treatment as usual
No Intervention group
Description:
standard treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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