A Personalized Prehabilitation Intervention In Elective Joint Replacement Surgery

Arthropathy of Knee Joint Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03601728
• Other study ID #: 826962
• Status: Suspended
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 28
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy of Hip Joint
• Arthropathy of Knee Joint
• Joint Diseases

Intervention

Behavioral:
• personalized prehabilitation
The 60-minute education session includes a 30-minute general education on exercise in older adults and a 30-minute instruction on participating in the study intervention (how to work with the personalized circadian-based activity guideline). The education session will be developed and presented by the PI and the certified exercise trainer. The general education session will be designed using materials from Go4Life program from the National Institute on Aging (https://go4life.nia.nig.gov). The personalized circadian-based activity guideline (exercise goal and plan) will be developed by the investigators and the exercise trainer based on the individual's typical daily circadian profile, functional status, preference for exercise.

Locations

Country	Name	City	State
United States	University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline, pre-prehabilitation cognitive function at 30±2 days post-operative	Difference in cognitive function as assessed by the CogState Brief Battery for the condition 'baseline, pre-prehabilitation' versus 30±2 days post-operative between Intervention vs. Control	30±2 days post-operative
Secondary	Change from baseline, pre-prehabilitation physical activity [vector magnitude] at 30±2 days post-operative	Difference in physical activity for the condition 'baseline, pre-prehabilitation' versus 30±2 days post-operative between Intervention vs. Control	30±2 days post-operative
Secondary	Change from baseline, pre-prehabilitation step count [number] at 30±2 days post-operative	Difference in step count for the condition 'baseline, pre-prehabilitation' versus 30±2 days post-operative between Intervention vs. Control	30±2 days post-operative
Secondary	Change from baseline, pre-prehabilitation sleep duration [hours] at 30±2 days post-operative Difference in sleep parameters	Difference in sleep duration for the condition 'baseline, pre-prehabilitation' versus 30±2 days post-operative between Intervention vs. Control	30±2 days post-operative
Secondary	Change from baseline, pre-prehabilitation circadian phase [hours] of activity	Difference in circadian phase for the condition 'baseline, pre-prehabilitation' versus 30±2 days post-operative between Intervention vs. Control	30±2 days post-operative
Secondary	Change from baseline, pre-prehabilitation circadian amplitude [difference between the maximum and minimum observed values] of activity	Difference in circadian phase for the condition 'baseline, pre-prehabilitation' versus 30±2 days post-operative between Intervention vs. Control	30±2 days post-operative
Secondary	Compliance	Compliance to the four-week prehabilitation paradigm assessed as the delta between the first and fourth (last) week of physical activity in the intervention group	2 months
Secondary	Difference in incidence of delirium	Difference in incidence of delirium between Intervention vs. Control assessed from patient charts at 'post-operative day 30±2'	30±2 days post-operative
Secondary	Difference in concentrations of Interleukin-6 (IL-6) [pg/mL]	Difference in concentrations between Intervention vs. Control	30±2 days post-operative
Secondary	Difference in concentrations of S100ß [ng/mL]	Difference in concentrations between Intervention vs. Control	30±2 days post-operative
Secondary	Difference in hospital length of stay	Difference in hospital length of stay [days] for Intervention vs. Control	30±2 days post-operative

External Links

•   Study description in a 1-minute YouTube video
•   Study support by the Penn Center for Precision Medicine (PCPM)