Back to results

Prehabilitation Exercise Plus Perioperative Optimization of Senior Health

Primary Purpose

Cognitive Decline, Age-Related Memory Disorders, Postoperative Complications

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Intervention

About this trial

This is an interventional prevention trial for Cognitive Decline

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise Intervention

Arm Description

Outcomes

Primary Outcome Measures

Feasibility of Preoperative exercise program

The number of patients contacted versus the number of patients enrolled will be tracked to determine recruitment feasibility. Reasons for refusal will be assessed.

Secondary Outcome Measures

Full Information

NCT ID

NCT03291795

First Posted

September 13, 2017

Last Updated

July 1, 2019

Sponsor

Duke University

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT03291795

Brief Title

Prehabilitation Exercise Plus Perioperative Optimization of Senior Health

Official Title

Prehabilitation Exercise Plus Perioperative Optimization of Senior Health

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Why Stopped

feasibility challenges

Study Start Date

August 20, 2017 (Actual)

Primary Completion Date

January 8, 2018 (Actual)

Study Completion Date

January 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Decline, Age-Related Memory Disorders, Postoperative Complications, Age-Related Atrophy, Postoperative Cognitive Dysfunction

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise Intervention

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Exercise Intervention

Intervention Description

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 Measure Information:

Title

Feasibility of Preoperative exercise program

Description

The number of patients contacted versus the number of patients enrolled will be tracked to determine recruitment feasibility. Reasons for refusal will be assessed.

Time Frame

approximately 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miles Berger, MD, PhD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Prehabilitation Exercise Plus Perioperative Optimization of Senior Health

We'll reach out to this number within 24 hrs