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NCT04412330 · ClinicalTrials.gov registry record · NA
Optimizing Outcomes With Physical Therapy Treatment for IndividuALs Surviving an ICU Admission for Covid-19
A NA study of COVID-19 and Critical Illness, sponsored by University of Kentucky.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT04412330 is a NA study of COVID-19 and Critical Illness that has completed, run by University of Kentucky. The registered enrollment target is 32 participants, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04412330, a NA study of COVID-19 and Critical Illness, has completed, sponsored by University of Kentucky.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
Introduction: Survivors of acute respiratory failure develop persistent muscle weakness and deficits in cardiopulmonary endurance combining to limit physical functioning. Early data from the Covid-19 pandemic suggest a high incidence of critically ill patients admitted to intensive care units (ICU) will require mechanical ventilation for acute respiratory failure. Covid-19 patients surviving an admission to the ICU are expected to suffer from physical and cognitive impairments that will limit quality of life and return to pre-hospital level of functioning. In this present study, the investigators will evaluate the safety and feasibility of providing a novel clinical pathway combining ICU after-care at an ICU Recovery clinic with physical therapy interventions. Methods and Analysis: In this single-center, prospective (pre, post cohort) trial in patients surviving ICU admission for Covid-19. The investigators hypothesize that this novel combination is a) safe and feasible to provide for patients surviving Covid-19; b) improve physical function and exercise capacity measured by performance on 6-minute walk test and Short Performance Physical battery; and c) reduce incidence of anxiety, depression and post-traumatic stress assessed with Hospital Anxiety and Depression Scale and the Impact of Events Scale-revised. Safety will be assessed by pooled adverse events and reason for early termination of interventions. Feasibility will be assessed by rate of adherence and attrition. Repeated measures ANOVA will be utilized to assess change in outcomes from at first ICU Recovery Clinic follow-up (2-weeks) and 3- and 6-months post hospital discharge. Ethics and Dissemination: The trial has received ethics approval at the University of Kentucky and enrollment has begun. The results of this trial will support the feasibility of providing ICU follow-up and physical therapy interventions for patients surviving critical illness for Covid-19 and may begin to support effectiveness of
Conditions Studied
Interventions
- OTHER ICU Recovery + Physical Therapy
Study Locations (1)
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-05-01 |
| Est. Completion | 2021-05-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04412330
The ClinicalTrials.gov registry entry for NCT04412330 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is University of Kentucky, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which ICU Recovery + Physical Therapy is the first listed.
NCT04412330 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT04412330 about?
NCT04412330 is a clinical study titled "Optimizing Outcomes With Physical Therapy Treatment for IndividuALs Surviving an ICU Admission for Covid-19". Introduction: Survivors of acute respiratory failure develop persistent muscle weakness and deficits in cardiopulmonary endurance combining to limit physical functioning. Early data from the Covid-19 pandemic suggest a high incidence of critically ill patients admitted to intensive care units (ICU) ...
What is the current status of trial NCT04412330?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2020-05-01. Estimated completion is 2021-05-05.
What conditions does trial NCT04412330 study?
This clinical trial studies the following conditions: COVID-19, Critical Illness, Muscle Weakness, Post Intensive Care Unit Syndrome.
What interventions are being tested in trial NCT04412330?
The interventions under investigation include: ICU Recovery + Physical Therapy (OTHER).
Who is sponsoring clinical trial NCT04412330?
This trial is sponsored by University of Kentucky, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04412330 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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