Actively Recruiting
Simultaneous Recumbent Cycling and Cognitive Training
Led by University of Missouri, Kansas City · Updated on 2024-12-06
50
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
U
University of Missouri, Kansas City
Lead Sponsor
S
St. Luke's Hospital, Kansas City, Missouri
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Simultaneous Recumbent Cycling and Cognitive Training
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45-64 years
- Admitted to medical or surgical ICUs (SLH & TMC) for more than 24 hours
- English-speaking
- Discharged home
- Able to provide consent
- Access to a telephone
- Experienced one or more delirium episodes in ICU (positive CAM-ICU)
You will not qualify if you...
- Cancer diagnosis with short life expectancy as determined by Primary Care Provider
- Receiving chemotherapy causing impaired cognition
- Diagnosed vascular dementia or other neurodegenerative diseases such as Alzheimer or Parkinson disease
- Documented alcohol consumption of 5 or more drinks per day
- Corrected vision worse than 20/80 on Snellen chart
- Low hearing or communication ability interfering with intervention and assessments
- Positive CAM-ICU (delirium) at hospital discharge
- Unable to participate in rehabilitation due to abnormal 6-minute walk test
- Any physical condition preventing recumbent cycling
- Recent documented history of drug abuse
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
Research Team
R
Rita S Lasiter, PhD
CONTACT
M
Matthew S Chrisman, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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