Prehabilitation Exercise Plus Perioperative Optimization of Senior Health

July 1, 2019 updated by: Duke University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
approximately 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute on Aging (NIA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2017

Primary Completion (ACTUAL)

January 8, 2018

Study Completion (ACTUAL)

January 8, 2018

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 20, 2017

First Posted (ACTUAL)

September 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00076925
  • P30AG028716 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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