A Personalized Prehabilitation Intervention In Elective Joint Replacement Surgery



Status:Not yet recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:55 - Any
Updated:2/14/2019
Start Date:April 1, 2019
End Date:December 31, 2024
Contact:Lavenia Banas, CRN
Email:banas@pennmedicine.upenn.edu
Phone:215-573-1862

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A Personalized Medicine Prehabilitation Intervention Delivered Using Wearable Mobile Devices to Improve Cognitive Function in Elective Joint Replacement Surgery

The mission is to develop novel interventions to improve cognitive function, and thereby
reducing delirium in hospitalized patients to improve perioperative outcomes. Delirium
affects up to 42% of hospitalized patients and disproportionately increases morbidity and
mortality in older adults, especially after surgical procedures. Current approaches prevent
only 30-40% of delirium cases. The goal is to use prehabilitation (an individualized exercise
regimen performed in the 2-4 weeks prior to admission) to improve peri-operative cognitive
status, mobility and recovery. Based on preliminary data, the investigators propose to deeply
phenotype patients, meaning to study the patient, the disease and surgery in a very detailed
fashion, with elective knee or hip replacement surgery and use a personalized prehabilitation
intervention compared to standard pre-operative care. To facilitate data collection over the
course of the study, the investigators use wearable devices and mobile phone applications.

The fiscal burden estimated at $164 billion annually in the US alone, with delirium often
leading to significant increases in hospital length of stay. The pathophysiology of delirium
is multifactorial and incompletely understood. Disruption of circadian rhythms, with
subsequent impairment of alertness, and increased inflammation including neuroinflammation,
is common in hospital environments, and is associated with poorer outcome, particularly in
the elderly.

An intriguing new therapeutic concept currently emerging in the area of elective surgery is
prehabilitation, a form of exercise training, which when pre-emptively administered in the
weeks prior to admission, has the potential to improve postoperative cognitive status,
mobility and recovery, thereby minimizing complications such as delirium. Our team has
recently developed a novel personalized medicine intervention that uses wearable devices
(smartwatches) to create an individualized exercise regimen for older adults that can
facilitate prehabilitation and monitor adherence to the prehabilitation regimen while the
patient is at home. In one sense, prehabilitation can be conceptualized as bouts of physical
exercise performed at home prior to admission, which, when adequately timed using guidance by
a wrist-worn biometric mobile device (smartwatch), augment the robustness of circadian
rhythms, particularly in the elderly. This intervention has the potential to have a high
impact because of its low cost, personalized nature, and ability to monitor adherence to
confirm maximization of functional status prior to admission.

Inclusion Criteria:

- Adults scheduled for elective arthroplasty;

- ≥55 years of age;

- Capable of giving informed consent;

- Willing to comply either to undergo prehabilitation (cases) or standard preoperative
care (control);

- Own a smartphone.

Exclusion Criteria:

- Patients with bilateral or revision surgeries;

- Diagnosis of pre-existing dementia;

- Test result of <20 in the MoCA indicating moderate to severe dementia;

- Diagnosis of acute stroke;

- Diagnosis of neurologic injury;

- Current alcohol (more than 2 drinks a day with last drink within the past 3 days) or
substance abuse (positive urine dip test for illicit drugs) history at risk of
postoperative withdrawal;

- Active diagnosis of alcohol or substance abuse;

- Recent travel across more than two (2) time zones (within the past month);

- Planned travel across more than two (2) time zones during the planned study
activities;

- Subjects, who have received an experimental drug, used an experimental medical device
within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8
weeks prior to screening;

- Subjects without access to WiFi in their or close to home or at work.
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
Principal Investigator: Carsten Skarke, M.D.
Phone: 215-573-1862
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mi
from
Philadelphia, PA
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