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NCT04006990 · ClinicalTrials.gov registry record · Phase 3
The Bed Rest Avoidance Study
A Phase 3 study of Study Focuses on Bed Rest and Deconditioning in Hospital Inpatients, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 3
- Development phase
- 6,089
- Enrollment target
- 1
- Study location
NCT04006990 is a Phase 3 study of Study Focuses on Bed Rest and Deconditioning in Hospital Inpatients that has completed, run by University of Southern California. The registered enrollment target is 6,089 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04006990, a Phase 3 study of Study Focuses on Bed Rest and Deconditioning in Hospital Inpatients, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 6,089 participants
- Enrollment target
- 1
- Study location
Study Summary
Hospitalized patients spend the majority of their time lying in bed, even when they are capable of being out of bed. Up to 50% of inpatients suffer functional decline at least in part due to lying in bed after admission, and even those who are not placed on bed rest by their physicians spend an average of 20 out of 24 hours lying in bed. The loss of functional ability and exercise tolerance happens remarkably fast, as early as hospital day 2 (24-48 hours). Functional decline often results in a prolonged hospital stay and the need for additional rehabilitation resources both during and after the hospitalization to return a patient to their baseline functional status. Functional decline has also been associated with excess mortality. The investigators sought to flip the culture of hospital-based care such that the bed was viewed as a place for patients to sleep, and patients would be encouraged to get out of bed when they were not trying to sleep. The investigators hypothesized that patients were unaware of the risks of prolonged immobilization and that the lack of an alternative comfortable place for patients to sit other than their bed contributed to their immobility. Previous studies have demonstrated that mobility protocols improve patient-centered outcomes in narrow patient populations such as post-surgical patients or the elderly, but such interventions have not been studied in a heterogeneous patient population. Additionally, previously studied protocols have been labor-intensive from a nursing standpoint, requiring, for example, that staff provide one-on-one supervised ambulation 3-4 times per day. The investigators aimed to determine whether establishing a relatively low-intensity, pragmatic protocol to discourage patients from lying in bed would result in shorter length of stay by improving mobility. The investigators further aimed to assess the additional impact of providing a recliner chair, a safe and comfortable alternative to their bed on these outcome
Conditions Studied
Interventions
- BEHAVIORAL Provision of recliner chairs and encouragement to get out of bed
Study Locations (1)
California
- LAC USC Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,089 participants |
| Start Date | 2017-03-20 |
| Est. Completion | 2017-09-19 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04006990
The ClinicalTrials.gov registry entry for NCT04006990 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 6,089 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Study Focuses on Bed Rest and Deconditioning in Hospital Inpatients appearing as the primary indexed condition, and to 1 intervention - of which Provision of recliner chairs and encouragement to get out of bed is the first listed.
NCT04006990 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04006990 about?
NCT04006990 is a clinical study titled "The Bed Rest Avoidance Study". Hospitalized patients spend the majority of their time lying in bed, even when they are capable of being out of bed. Up to 50% of inpatients suffer functional decline at least in part due to lying in bed after admission, and even those who are not placed on bed rest by their physicians spend an aver...
What is the current status of trial NCT04006990?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 6,089 participants. The study started on 2017-03-20. Estimated completion is 2017-09-19.
What conditions does trial NCT04006990 study?
This clinical trial studies the following conditions: Study Focuses on Bed Rest and Deconditioning in Hospital Inpatients.
What interventions are being tested in trial NCT04006990?
The interventions under investigation include: Provision of recliner chairs and encouragement to get out of bed (BEHAVIORAL).
Who is sponsoring clinical trial NCT04006990?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04006990 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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