A Personalized Prehabilitation Intervention In Elective Joint Replacement Surgery

NCT ID: NCT03601728

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2028-12-31

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.

Conditions

Arthropathy of Knee Joint; Arthropathy of Hip Joint

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Enhanced Monitoring Program

Four weeks prior to the scheduled (elective) surgery, participants will receive a 60-minute in person education session how to increase the level of physical activity. This will be followed by 4 weeks of keeping this level of physical activity, which will be monitored and supported by personalized interactive prompts delivered by a smartwatch. This approach is called personalized prehabilitation.

Group Type: EXPERIMENTAL

personalized prehabilitation

Intervention Type: BEHAVIORAL

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.

Regular Monitoring Program

Participants randomized to this arm will receive standard perioperative care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Enhanced Monitoring Program

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Carsten Skarke, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carsten Skarke, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29215023 (View on PubMed)

Related Links

https://lp.pennmedicine.org/precision-medicine/general?hcmacid=pm

Study support by the Penn Center for Precision Medicine (PCPM)

https://www.youtube.com/watch?v=XpEu03PQM0Q

Study description in a 1-minute YouTube video

Other Identifiers

826962

Identifier Type: -

Identifier Source: org_study_id