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TSA Exercise Prehabilitation in Older Adults

Primary Purpose

Postoperative Delirium and Delayed Functional Recovery

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise Training (AET)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Delirium and Delayed Functional Recovery focused on measuring aerobic exercise training, delirium

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
Patients scheduled for total shoulder replacement

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Aerobic Exercise Training (AET)

treatment as usual

Arm Description

20 sessions of AET over a 4 week period just prior to surgery

standard treatment

Outcomes

Primary Outcome Measures

Cognitive Function after surgery
Cognition will be assessed using the Nursing Delirium Screen (NU-DESC) scale to determine if there is any change
Cognitive Function after surgery
Cognition will be assessed using the Family Confusion Assessment Method (FAM-CAM) questionnaire to determine if there is any change

Secondary Outcome Measures

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
CyTOF of blood samples
Blood samples will be collected prior to the intervention, prior to and after surgery for high dimensional mass cytometry

Full Information

First Posted
July 6, 2017
Last Updated
August 12, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03212300
Brief Title
TSA Exercise Prehabilitation in Older Adults
Official Title
Plasticity in Recovery From Surgery: The Effects of Exercise "Prehabilitation" on Cognitive and Functional Recovery After Shoulder Replacement in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Inadequate data analysis
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
August 12, 2020 (Actual)
Study Completion Date
August 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium and Delayed Functional Recovery
Keywords
aerobic exercise training, delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise Training (AET)
Arm Type
Active Comparator
Arm Description
20 sessions of AET over a 4 week period just prior to surgery
Arm Title
treatment as usual
Arm Type
No Intervention
Arm Description
standard treatment
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise Training (AET)
Other Intervention Name(s)
High Intensity Interval Training (HIIT)
Intervention Description
20 sessions of AET over a 4 week period just prior to surgery
Primary Outcome Measure Information:
Title
Cognitive Function after surgery
Description
Cognition will be assessed using the Nursing Delirium Screen (NU-DESC) scale to determine if there is any change
Time Frame
up to hospital discharge (approximately 1 day)
Title
Cognitive Function after surgery
Description
Cognition will be assessed using the Family Confusion Assessment Method (FAM-CAM) questionnaire to determine if there is any change
Time Frame
up to 12 weeks post-operatively
Secondary Outcome Measure Information:
Title
Functional Recovery after surgery
Description
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
Time Frame
up to 12 weeks post-operatively
Title
CyTOF of blood samples
Description
Blood samples will be collected prior to the intervention, prior to and after surgery for high dimensional mass cytometry
Time Frame
Before exercise (approximately 4 weeks before surgery), after exercise (on the morning of surgery), and 1 hour, 6 hours, and 24 hours post-surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients scheduled for total shoulder replacement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mervyn Maze, MB, CHB
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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TSA Exercise Prehabilitation in Older Adults

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