Prehabilitation Exercise Plus Perioperative Optimization of Senior Health

NCT03291795 | Terminated

• 2 other identifiers: Pro00076925P30AG028716
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  approximately 18 months

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

Other: Exercise Intervention

Interventions

Exercise Intervention OTHER

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.

Exercise Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders; Postoperative Complications; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

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

Study Officials

• Miles Berger, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 25, 2017
• Study Start: August 20, 2017
• Primary Completion: January 8, 2018
• Study Completion: January 8, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-06

Locations

US (1)