Arthropathy of Knee JointNCT03601728
A Personalized Prehabilitation Intervention In Elective Joint Replacement Surgery
A study testing personalized prehabilitation in people with Arthropathy of Knee Joint and Arthropathy of Hip Joint, run by University of Pennsylvania at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Arthropathy of Knee Joint, Arthropathy of Hip Joint
- What is being tested?
- personalized prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Being tested
- personalized prehabilitation
- Keywords
- elective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized prehabilitationBehavioural
Also called Enhanced Monitoring Program
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Monitoring Program | Experimental | 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. Receives: Behavioral: personalized prehabilitation |
| Regular Monitoring Program | No intervention | Participants randomized to this arm will receive standard perioperative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30±2 days post-operative
Secondary outcomes (10)
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
Measured: 30±2 days post-operative
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
Measured: 30±2 days post-operative
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
Measured: 30±2 days post-operative
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
Measured: 30±2 days post-operative
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
Measured: 30±2 days post-operative
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
Measured: 2 months
Difference in incidence of delirium
Difference in incidence of delirium between Intervention vs. Control assessed from patient charts at 'post-operative day 30±2'
Measured: 30±2 days post-operative
Difference in concentrations of Interleukin-6 (IL-6) [pg/mL]
Difference in concentrations between Intervention vs. Control
Measured: 30±2 days post-operative
Difference in concentrations of S100β [ng/mL]
Difference in concentrations between Intervention vs. Control
Measured: 30±2 days post-operative
Difference in hospital length of stay
Difference in hospital length of stay [days] for Intervention vs. Control
Measured: 30±2 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Oct 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Why it stopped: Covid-19 Crisis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of Knee JointStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Matched case-control study design
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Skarke, MD, University of Pennsylvania
- Investigators
- Carsten Skarke, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601728
- Sponsor's protocol ID
- 826962
- Status last verified
- May 2026
- First submitted
- 3 May 2018
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to be determined
Publications
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.
PubMed 29215023
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Medicine Prehabilitation Intervention Delivered Using Wearable Mobile Devices to Improve Cognitive Function in Elective Joint Replacement Surgery
- ClinicalTrials.gov ID
- NCT03601728
- Acronym / sponsor ID
- 826962
- Keywords
- elective
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Covid-19 Crisis
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Matched case-control study design
| Arm | Type | Receives |
|---|---|---|
| Enhanced Monitoring Program | Experimental | Behavioral: personalized prehabilitationFour 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. |
| Regular Monitoring Program | No intervention | –Participants randomized to this arm will receive standard perioperative care. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| personalized prehabilitationAlso: Enhanced Monitoring ProgramThe 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. | Behavioural | Enhanced Monitoring Program |
Primary outcome
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
10 secondary outcomes
Change from baseline, pre-prehabilitation physical activity [vector magnitude] at 30±2 days post-operative
Time frame: 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
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
Change from baseline, pre-prehabilitation circadian phase [hours] of activity
Time frame: 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
Compliance
Time frame: 2 months
Difference in incidence of delirium
Time frame: 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 of S100β [ng/mL]
Time frame: 30±2 days post-operative
Difference in hospital length of stay
Time frame: 30±2 days post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 29215023Skarke 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.
- Study support by the Penn Center for Precision Medicine (PCPM)Link provided by the sponsor.
- Study description in a 1-minute YouTube videoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. to be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Skarke, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized prehabilitation in people with Arthropathy of Knee Joint and Arthropathy of Hip Joint, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline, pre-prehabilitation cognitive function at 30±2 days post-operative (time frame: 30±2 days post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03601728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.