Prehabilitation Exercise Plus Perioperative Optimization of Senior Health
Status: | Suspended |
---|---|
Conditions: | Cognitive Studies, Cognitive Studies, Cognitive Studies, Hospital |
Therapuetic Areas: | Psychiatry / Psychology, Other |
Healthy: | No |
Age Range: | 60 - Any |
Updated: | 1/19/2019 |
Start Date: | August 20, 2017 |
End Date: | December 1, 2019 |
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.
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.
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.
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.
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.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Miles Berger, MD, PhD
Phone: 919-691-2849
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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