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NCT04556227 · ClinicalTrials.gov registry record · NA
Simultaneous Recumbent Cycling and Cognitive Training
A NA study of Delirium and Impaired Cognition, sponsored by University of Missouri, Kansas City.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04556227: Recruiting NA study of Delirium and Impaired Cognition, sponsored by University of Missouri, Kansas City.
NCT04556227 is a NA study of Delirium and Impaired Cognition that is actively recruiting participants, run by University of Missouri, Kansas City. The registered enrollment target is 50 participants, below the 887-participant average among 62 other Delirium trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04556227, a NA study of Delirium and Impaired Cognition, is actively recruiting participants, sponsored by University of Missouri, Kansas City.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Intensive care units (ICU) provide life-saving care for nearly five million people annually. Up to 80% of patients receiving care in an ICU experience at least one episode of delirium. Delirium, an acute episodic display of confused thinking and unawareness, predicts impaired cognition and accelerated cognitive decline which negatively impacts quality of life (QOL) long after hospital discharge. The average age of ICU patients is 52 years. These middle-age (MA) ICU survivors need cognitive interventions that are well planned, accessible, and effective to improve cognition and prevent accelerated decline so they can resume their previous QOL and enter older age with optimized cognitive function. Physical exercise and cognitive training independently improve cognition and emerging evidence indicates that combining these two approaches produces even greater effects on cognition. Community-based rehabilitation centers are accessible for MAICU survivors to engage in physical activity; cognitive training could easily be added. Approaches in which a patient engages in physical exercise and cognitive training concurrently is an understudied intervention for all ICU survivors, especially those who are middle-aged. Study aims are to investigate the feasibility and acceptability of a simultaneous recumbent cycling and cognitive training intervention (SRCCT) for MAICU survivors who experienced at least one delirium episode during their ICU stay. Feasibility will be determined by systematically evaluating research team training, participant recruitment, randomization, implementation, and intervention fidelity. Acceptability will be evaluated via a satisfaction, preferences, burden, and participant-suggested improvements survey. The SRCCT effect sizes will be calculated comparing multiple data point cognition scores between an SRCCT group and a usual care control group. Upon completion, investigators expect to understand the feasibility and acceptability of the SRCCT delivered in
Primary Outcome
Feasibility of participant recruitment, randomization, intervention, intervention fidelity, and data collection. Less problems to overcome with recruitment, randomization, administering intervention, and data collection the more feasible the study.
Conditions Studied
Interventions
- BEHAVIORAL Simultaneous Cycle/Cognitive Training
Study Locations (1)
Missouri
- St. Luke's Hospital of Kansas City - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-12-03 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What NCT04556227 shows while recruiting
NCT04556227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 887-participant average among 62 other Delirium trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Delirium appearing as the primary indexed condition, and to 1 intervention - of which Simultaneous Cycle/Cognitive Training is the first listed.
NCT04556227 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04556227 about?
NCT04556227 is a clinical study titled "Simultaneous Recumbent Cycling and Cognitive Training". Intensive care units (ICU) provide life-saving care for nearly five million people annually. Up to 80% of patients receiving care in an ICU experience at least one episode of delirium. Delirium, an acute episodic display of confused thinking and unawareness, predicts impaired cognition and accelerat...
What is the current status of trial NCT04556227?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-12-03. Estimated completion is 2025-12-31.
What conditions does trial NCT04556227 study?
This clinical trial studies the following conditions: Delirium, Impaired Cognition.
What interventions are being tested in trial NCT04556227?
The interventions under investigation include: Simultaneous Cycle/Cognitive Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT04556227?
This trial is sponsored by University of Missouri, Kansas City, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04556227 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04556227's enrollment target sits among peer trials
50 49th of 62 higher than 13 of 62 other Delirium trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Delirium trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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