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Prehabilitation Exercise Plus Perioperative Optimization of Senior Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03291795
Recruitment Status : Terminated (feasibility challenges)
First Posted : September 25, 2017
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is the examine the feasibility of and estimate the efficacy of a preoperative exercise (i.e. prehabilitation) program in 40 up to sedentary older adults (i.e. age 60 and over) undergoing abdominal, urologic or gynecologic surgery under the Enhanced Recovery After Surgery (ERAS) protocol at Duke, using a variety of techniques to measure the possible effect of this intervention. Study patients will undergo a program of prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist, for up to 4 weeks prior to surgery. Study participants will undergo four types of assessments: Functional/Cognitive testing; Blood/cerebrospinal fluid (CSF) samples and Muscle biopsies; Brain Imaging; and Brain Activity Recording. Clinical Outcomes will also be obtained from the Duke electronic medical record system. The risks of the exercise intervention are generally mild, since moderate exercise in this patient population generally results in improved health outcomes. Data from these patients will be analyzed in comparison to propensity matched patients from the Duke Markers of Alzheimer's Disease and neurocognitive Outcomes after Perioperative Care (MADCO-PC) study who did not undergo this prehabilitation exercise intervention. Taken together, the results of this study will allow the investigators to estimate the possible effect of prehabilitation exercise on multiple domains of postoperative recovery (cognition, brain connectivity, biomarkers, brain activity, etc) and will provide important preliminary data.

Condition or disease Intervention/treatment Phase
Cognitive Decline Age-Related Memory Disorders Postoperative Complications Age-Related Atrophy Postoperative Cognitive Dysfunction Other: Exercise Intervention Not Applicable

Detailed Description:
The purpose of this study is the examine the feasibility of and estimate the efficacy of a preoperative exercise (i.e. prehabilitation) program in 40 up to sedentary older adults (i.e. age 60 and over) undergoing abdominal, urologic or gynecologic surgery under the Enhanced Recovery After Surgery (ERAS) protocol at Duke, using a variety of techniques to measure the possible effect of this intervention. Study patients will undergo a program of prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist, for up to 4 weeks prior to surgery. Study participants will undergo four types of assessments: Functional/Cognitive testing; Blood/CSF samples and Muscle biopsies; Brain Imaging; and Brain Activity Recording. Clinical Outcomes will also be obtained from the Duke electronic medical record system. The risks of the exercise intervention are generally mild, since moderate exercise in this patient population generally results in improved health outcomes. Data from these patients will be analyzed in comparison to propensity matched patients from the Duke Markers of Alzheimer's Disease and neurocognitive Outcomes after Perioperative Care (MADCO-PC) study who did not undergo this prehabilitation exercise intervention. Taken together, the results of this study will allow the investigators to estimate the possible effect of prehabilitation exercise on multiple domains of postoperative recovery (cognition, brain connectivity, biomarkers, brain activity, etc) and will provide important preliminary data and will help design future more definitive studies to test these hypotheses.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prehabilitation Exercise Plus Perioperative Optimization of Senior Health
Actual Study Start Date : August 20, 2017
Actual Primary Completion Date : January 8, 2018
Actual Study Completion Date : January 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Intervention Other: Exercise Intervention
Study patients will undergo a program of prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist, for up to 4 weeks prior to surgery.




Primary Outcome Measures :
  1. Feasibility of Preoperative exercise program [ Time Frame: approximately 18 months ]
    The number of patients contacted versus the number of patients enrolled will be tracked to determine recruitment feasibility. Reasons for refusal will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 60 and above
  • Able to speak English.
  • seen, scheduled to be seen, or eligible to be seen in Preoperative Optimization of Senior Health (POSH) clinic prior to surgery
  • scheduled for general, gynecologic or urologic surgery under the Enhanced Recovery After Surgery (ERAS) protocol, or eligible for ERAS protocol
  • Lives within a ~1 hr drive of Duke
  • Sedentary (not currently following physical activity guidelines)
  • Ambulatory (assistive devices ok)
  • Able to give informed consent
  • Willing to perform prescribed exercises

Exclusion Criteria:

  • Inmate of a correctional facility (i.e. prisoners).
  • Documented or suspected family or personal history of malignant hyperthermia.
  • Allergy or other contraindication to receiving isoflurane
  • Receiving systemic chemotherapy after the first cognitive testing session and before the 6 wk follow up cognitive testing sessions.
  • Major head trauma that occurs after the first cognitive testing session and before the 6 wk follow up cognitive testing sessions.
  • Anginal symptoms, known coronary artery disease (CAD), or high cardiovascular risk per American College of Cardiology (ACC)/ American Heart Association (AHA) guidelines
  • Taking anticoagulants that would preclude lumbar puncture per the American Society of Regional Anesthesia guidelines.
  • Diagnosed history of dementia.
  • Inability to ambulate independently.
  • Otherwise not appropriate for study participation in the judgement of the Principal Investigator, such as (but not limited to) because the patient does not have the cardiopulmonary capacity to complete the exercise regimen.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291795


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Miles Berger, MD, PhD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03291795    
Other Study ID Numbers: Pro00076925
P30AG028716 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Memory Disorders
Atrophy
Postoperative Complications
Cognitive Dysfunction
Pathological Conditions, Anatomical
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases