TSA Exercise Prehabilitation in Older Adults

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

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Delirium and Delayed Functional Recovery
• Intervention / Treatment: Behavioral: Aerobic Exercise Training (AET)

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Patients scheduled for total shoulder replacement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2018
• Primary Completion (Actual): August 12, 2020
• Study Completion (Actual): August 12, 2020

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: delirium; aerobic exercise training
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 1620740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No