A Personalized Prehabilitation Intervention In Elective Joint Replacement Surgery

May 28, 2026 updated by: Carsten Skarke, MD, University of Pennsylvania

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania School of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Other Names:
  • Enhanced Monitoring Program
No Intervention: Regular Monitoring Program
Participants randomized to this arm will receive standard perioperative care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline, pre-prehabilitation cognitive function at 30±2 days post-operative
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline, pre-prehabilitation physical activity [vector magnitude] at 30±2 days post-operative
Time Frame: 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
Change from baseline, pre-prehabilitation step count [number] at 30±2 days post-operative
Time Frame: 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
Change from baseline, pre-prehabilitation sleep duration [hours] at 30±2 days post-operative Difference in sleep parameters
Time Frame: 30±2 days post-operative
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
Change from baseline, pre-prehabilitation circadian phase [hours] of activity
Time Frame: 30±2 days post-operative
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
Change from baseline, pre-prehabilitation circadian amplitude [difference between the maximum and minimum observed values] of activity
Time Frame: 30±2 days post-operative
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
Compliance
Time Frame: 2 months
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
Difference in incidence of delirium
Time Frame: 30±2 days post-operative
Difference in incidence of delirium between Intervention vs. Control assessed from patient charts at 'post-operative day 30±2'
30±2 days post-operative
Difference in concentrations of Interleukin-6 (IL-6) [pg/mL]
Time Frame: 30±2 days post-operative
Difference in concentrations between Intervention vs. Control
30±2 days post-operative
Difference in concentrations of S100β [ng/mL]
Time Frame: 30±2 days post-operative
Difference in concentrations between Intervention vs. Control
30±2 days post-operative
Difference in hospital length of stay
Time Frame: 30±2 days post-operative
Difference in hospital length of stay [days] for Intervention vs. Control
30±2 days post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carsten Skarke, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 826962

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

to be determined

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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