TSA Exercise Prehabilitation in Older Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Plasticity in Recovery From Surgery: The Effects of Exercise Prehabilitation on Cognitive and Functional Recovery After Shoulder Replacement in Older Adults

Conditions
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Postoperative Delirium and Delayed Functional Recovery

Intervention / Treatment
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* Behavioral: Aerobic Exercise Training (AET)


Participation Criteria
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Eligibility Criteria
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Patients scheduled for total shoulder replacement

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aerobic Exercise Training (AET)<br>20 sessions of AET over a 4 week period just prior to surgery | Behavioral: Aerobic Exercise Training (AET)<br>* 20 sessions of AET over a 4 week period just prior to surgery<br>* Other names: High Intensity Interval Training (HIIT);|
| No Intervention: treatment as usual<br>standard treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Function after surgery | Cognition will be assessed using the Nursing Delirium Screen (NU-DESC) scale to determine if there is any change | up to hospital discharge (approximately 1 day) | 
| Cognitive Function after surgery | Cognition will be assessed using the Family Confusion Assessment Method (FAM-CAM) questionnaire to determine if there is any change | up to 12 weeks post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Recovery after surgery | 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 | up to 12 weeks post-operatively | 
| CyTOF of blood samples | Blood samples will be collected prior to the intervention, prior to and after surgery for high dimensional mass cytometry | Before exercise (approximately 4 weeks before surgery), after exercise (on the morning of surgery), and 1 hour, 6 hours, and 24 hours post-surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aerobic exercise training, delirium