Prehabilitation Exercise Plus Perioperative Optimization of Senior Health

Duke University

Status

Terminated

Conditions

Postoperative Complications

Age-Related Memory Disorders

Age-Related Atrophy

Cognitive Decline

Postoperative Cognitive Dysfunction

Treatments

Other: Exercise Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03291795

P30AG028716 (U.S. NIH Grant/Contract)

Pro00076925

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

60+ years old

Volunteers

No 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.