A Personalized Prehabilitation Intervention In Elective Joint Replacement Surgery (NCT03601728) | Clinical Trial Compass
SuspendedNot Applicable
A Personalized Prehabilitation Intervention In Elective Joint Replacement Surgery
Stopped: Covid-19 Crisis
United States28 participantsStarted 2019-10-01
Plain-language 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.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline, pre-prehabilitation cognitive function at 30±2 days post-operative