Simultaneous Recumbent Cycling and Cognitive Training (NCT04556227)
Simultaneous Recumbent Cycling and Cognitive Training on Cognition in Intensive Care Unit Survivors: a Randomized Control Trial
๐ฉบ Plain-English Summary (8th-Grade Level)
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 community-based rehabilitation centers, and the combined effect of SRCCT on cognition and QOL for middle-aged ICU survivors who experienced an episode of ICU delirium. The hypothesis is that study participants who engage in physical exercise and cognitive training concurrently will have a greater improvement in cognition and QOL than physical exercise training alone.
Who can join: Review the eligibility criteria below.
Location: St. Luke's Hospital of Kansas City โ Kansas City, Missouri
Age range: 45 Years to 64 Years
๐งช Interventions in This Study
- Simultaneous Cycle/Cognitive Training (BEHAVIORAL)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- St. Luke's Hospital of Kansas City โ Kansas City, Missouri
๐ Contact the Study Coordinator
Phone: (816) 235-6766
Email: LasiterR@umkc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Delirium
- Digital Rehabilitation Environment Augmenting Medical System โ Gainesville, Florida
- Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care โ Houston, Texas
- Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors โ Rockford, Illinois
- Intelligent Intensive Care Unit โ Gainesville, Florida
- Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium โ St Louis, Missouri
- Dexmedetomidine to Reduce the Incidence of POCD After Open Cardiac Surgery โ Toronto, Ontario
Explore by condition: All Delirium clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.