- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03601728
A Personalized Prehabilitation Intervention In Elective Joint Replacement Surgery
A Personalized Medicine Prehabilitation Intervention Delivered Using Wearable Mobile Devices to Improve Cognitive Function in Elective Joint Replacement Surgery
Study Overview
Status
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
---|---|
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.
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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:
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No Intervention: Regular Monitoring Program
Participants randomized to this arm will receive standard perioperative care.
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What is the study measuring?
Primary Outcome Measures
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
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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
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30±2 days post-operative
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Secondary Outcome Measures
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
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Difference in physical activity for the condition 'baseline, pre-prehabilitation' versus 30±2 days post-operative between Intervention vs.
Control
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30±2 days post-operative
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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
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30±2 days post-operative
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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
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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
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Change from baseline, pre-prehabilitation circadian phase [hours] of activity
Time Frame: 30±2 days post-operative
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Difference in circadian phase for the condition 'baseline, pre-prehabilitation' versus 30±2 days post-operative between Intervention vs.
Control
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30±2 days post-operative
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Change from baseline, pre-prehabilitation circadian amplitude [difference between the maximum and minimum observed values] of activity
Time Frame: 30±2 days post-operative
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Difference in circadian phase for the condition 'baseline, pre-prehabilitation' versus 30±2 days post-operative between Intervention vs.
Control
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30±2 days post-operative
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Compliance
Time Frame: 2 months
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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
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2 months
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Difference in incidence of delirium
Time Frame: 30±2 days post-operative
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Difference in incidence of delirium between Intervention vs.
Control assessed from patient charts at 'post-operative day 30±2'
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30±2 days post-operative
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Difference in concentrations of Interleukin-6 (IL-6) [pg/mL]
Time Frame: 30±2 days post-operative
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Difference in concentrations between Intervention vs.
Control
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30±2 days post-operative
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Difference in concentrations of S100β [ng/mL]
Time Frame: 30±2 days post-operative
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Difference in concentrations between Intervention vs.
Control
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30±2 days post-operative
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Difference in hospital length of stay
Time Frame: 30±2 days post-operative
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Difference in hospital length of stay [days] for Intervention vs.
Control
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30±2 days post-operative
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carsten Skarke, MD, University of Pennsylvania
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 826962
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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