Clinical trial NCT03601728: A Personalized Prehabilitation Intervention In Elective Joint Replacement Surgery
Official title: A Personalized Medicine Prehabilitation Intervention Delivered Using Wearable Mobile Devices to Improve Cognitive Function in Elective Joint Replacement Surgery
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Arthropathy of Knee Joint
Arthropathy of Hip Joint
Keywords: elective
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 28
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Matched case-control study design
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline, pre-prehabilitation cognitive function at 30±2 days post-operative
timeFrame: 30±2 days post-operative
Secondary outcomes:
measure: Change from baseline, pre-prehabilitation physical activity [vector magnitude] at 30±2 days post-operative
timeFrame: 30±2 days post-operative
measure: Change from baseline, pre-prehabilitation step count [number] at 30±2 days post-operative
timeFrame: 30±2 days post-operative
measure: Change from baseline, pre-prehabilitation sleep duration [hours] at 30±2 days post-operative Difference in sleep parameters
timeFrame: 30±2 days post-operative
measure: Change from baseline, pre-prehabilitation circadian phase [hours] of activity
timeFrame: 30±2 days post-operative
measure: Change from baseline, pre-prehabilitation circadian amplitude [difference between the maximum and minimum observed values] of activity
timeFrame: 30±2 days post-operative
measure: Compliance
timeFrame: 2 months
measure: Difference in incidence of delirium
timeFrame: 30±2 days post-operative
measure: Difference in concentrations of Interleukin-6 (IL-6) [pg/mL]
timeFrame: 30±2 days post-operative
measure: Difference in concentrations of S100β [ng/mL]
timeFrame: 30±2 days post-operative
measure: Difference in hospital length of stay
timeFrame: 30±2 days post-operative
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Carsten Skarke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skarke C, Lahens NF, Rhoades SD, Campbell A, Bittinger K, Bailey A, Hoffmann C, Olson RS, Chen L, Yang G, Price TS, Moore JH, Bushman FD, Greene CS, Grant GR, Weljie AM, FitzGerald GA. A Pilot Characterization of the Human Chronobiome. Sci Rep. 2017 Dec 7;7(1):17141. doi: 10.1038/s41598-017-17362-6.