ClinicalTrials.gg
TerminatedNCT03291795Updated Jul 5, 2019

Prehabilitation Exercise Plus Perioperative Optimization of Senior Health

An interventional study of Exercise Intervention in Cognitive Decline, Age-Related Memory Disorders and Postoperative Complications, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-07-05.

Primary conditionPostoperative Cognitive ComplicationsRegistry: Cognitive DysfunctionReclassifiedWhy we changed it
Registry
Cognitive Dysfunction — the first condition term the registry derived for this study.
ClinicalTrials.gg
Postoperative Cognitive Complications
Why
  1. The study's listed conditions name Postoperative Cognitive Complications, a narrower term within Cognitive Dysfunction.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Duke University · Not applicable, Interventional, and Prevention

Why this study was terminated
feasibility challenges

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Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 35 studies in Postoperative Cognitive Complications with a site in United States — 6 open to participants now, 7 under way, none of them phase 3. Postoperative Cognitive Complications · United States.

Enrollment
20th of 22
6 · median 63
Started
2017
with 1 other
No phase
12 of 35
3 open now
Registered
19th of 35
by date
Lead sponsor
2 of 35
Duke University

Among the 35 studies in Postoperative Cognitive Complications with a site in United States, this one is the 20th largest by enrollment of the 22 interventional ones that give a count, is one of 2 that started in 2017, is one of 12 with no phase, and was the 19th registered.

Postoperative Cognitive Complications

260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.

Browse Postoperative Cognitive Complications studies →

Open to participants now

6 of the 35 studies in Postoperative Cognitive Complications with a site in United States are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 34 Postoperative Cognitive Complications studies recruiting now, 22 (65%) set no upper age limit and 4 (12%) stop at 75 or younger; 2 take children under 18; 6 take healthy volunteers.

This study: 60 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 35 studies in Postoperative Cognitive Complications with a site in United States, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Cognitive Decline
  • Age-Related Memory Disorders
  • Postoperative Complications
  • Age-Related Atrophy
  • Postoperative Cognitive Dysfunction
04

In context

Postoperative Cognitive Complications Reclassified

260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.

This study's enrollment of 6 is below the median of 107 across 145 interventional studies indexed under Postoperative Cognitive Complications.

Browse Postoperative Cognitive Complications studies →

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 272 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Compared within Postoperative Cognitive Complications, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cognitive Dysfunction. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Willing to perform prescribed exercises

Exclusion criteria

Exclusion Criteria:

  • Inmate of a correctional facility (i.e. prisoners).
  • Documented or suspected family or personal history of malignant hyperthermia.
  • Allergy or other 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

06

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Exercise Intervention

    Other: Exercise Intervention

Interventions

  • OtherExercise 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.

07

What researchers measure

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.

    Time frame: approximately 18 months

08

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in Jan 2018, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2017
First posted
Sep 25, 2017
StartActual
Aug 20, 2017
Primary completionActual
Jan 8, 2018
CompletionActual
Jan 8, 2018
Last update
Jul 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03291795
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
Aug 20, 2017
Primary completion
Jan 8, 2018
Completion
Jan 8, 2018
Last update
Jul 5, 2019

Study contacts

Miles Berger, MD, PhD
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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