Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2018-09-28
2020-08-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Aerobic Exercise Training (AET)
20 sessions of AET over a 4 week period just prior to surgery
Aerobic Exercise Training (AET)
20 sessions of AET over a 4 week period just prior to surgery
treatment as usual
standard treatment
No interventions assigned to this group
Interventions
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Aerobic Exercise Training (AET)
20 sessions of AET over a 4 week period just prior to surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
55 Years
75 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Mervyn Maze, MB, CHB
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California San Francisco
San Francisco, California, United States
Countries
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Other Identifiers
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1620740
Identifier Type: -
Identifier Source: org_study_id
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