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Summary

for people ages 55–75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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 could be experienced after undergoing surgery.

Official Title

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

Details

In this study, patients awaiting TSR who consent to participate in the study will be randomly assigned to receive 4 weeks of high intensity interval aerobic exercise training or treatment as usual for the 4 weeks prior to surgery. Exercise training will be on a recumbent cycle ergometer provided by the study. All patients will receive cognitive testing before and on several days after surgery. Blood also will be drawn on several occasions throughout the study to measure inflammatory markers.

Keywords

Post-operative Delirium aerobic exercise training delirium

Eligibility

You can join if…

Open to people ages 55–75

  1. scheduled for total shoulder replacement
  2. 55-75 years of age.
  3. Willing and able to sign an informed consent form and HIPAA authorization and to comply with study procedures.
  4. Medical clearance from the treating physician in order to participate in the study and perform the training.
  5. BMI < 35 kg/m2.
  6. Normal EKG determined by the treating
  7. Montreal Cognitive Assessment score ≥ 24.
  8. Access to a computer or smartphone.
  9. Surgery is scheduled after completing the four weeks of High Intensity Interval Training or Treatment as usual.
  10. . Agree to abstain from exercise for a four-week period prior to surgery if randomized to the Treatment as Usual group.

You CAN'T join if...

  1. Infectious disease within the last month.
  2. Immune- suppressant therapy within the last 2 months (e.g., azathioprine or cyclosporine).
  3. Chronic medication with potential immune-modulatory effects.
  4. Major surgery within the last 3 months or minor surgery within the last month.
  5. History of substance abuse (e.g., alcoholism, drug dependency).
  6. Pregnancy.
  7. Autoimmune disease interfering with data interpretation (e.g. lupus).
  8. Renal, hepatic, cardiovascular, or respiratory diseases resulting in clinically relevant impaired function.
  9. Pre-existing CVA, dementia, and other neurological conditions that would interfere with their ability to participate physically and cognitively.
  10. . Active malignancy.
  11. . Participation in another clinical trial within the last month that, in the Investigators' opinion, would create an increased risk to the patient or compromise the study's integrity.
  12. . Abnormal EKG determined by the treating physician.
  13. . Have no access to a computer or smartphone.
  14. . Engage in routinely vigorous exercise. Baecke activity score ≥ 10

Locations

  • Columbia University Medical Center accepting new patients
    New York, New York, 10032, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
New York State Psychiatric Institute
ID
NCT03212300
Study Type
Interventional
Last Updated
July 1, 2017
I’m interested in this study!