TSA Exercise Prehabilitation in Older Adults

NCT03212300 | Terminated

• 1 other identifier: 1620740
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium and Delayed Functional Recovery

Keywords

aerobic exercise training; delirium

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Functional Recovery after surgery

  up to 12 weeks post-operatively

• CyTOF of blood samples

  Before exercise (approximately 4 weeks before surgery), after exercise (on the morning of surgery), and 1 hour, 6 hours, and 24 hours post-surgery.

Study Arms (2)

Aerobic Exercise Training (AET)

ACTIVE COMPARATOR

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

Behavioral: Aerobic Exercise Training (AET)

treatment as usual

NO INTERVENTION

standard treatment

Interventions

Aerobic Exercise Training (AET) BEHAVIORAL

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

Also known as: High Intensity Interval Training (HIIT)

Aerobic Exercise Training (AET)

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Patients scheduled for total shoulder replacement

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Emergence Delirium; Delirium

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mervyn Maze, MB, CHB

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: September 28, 2018
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)