Simultaneous Recumbent Cycling and Cognitive Training

Recruiting now · Not applicable

Conditions studied: Delirium, Impaired Cognition

In brief

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.

Key facts

Study ID

NCT04556227

Run by

University of Missouri, Kansas City

People needed

50

Starts

2024-12-03

Expected to finish

2025-12-31

Last updated by the study team

2024-12-06

Who can join

Age: 45 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 45-64 years
• Admitted to medical or surgical ICUs (SLH \& TMC) for >24 hours
• English-speaking
• Discharged home
• Able to provide consent
• Access to a telephone
• One or more delirium episode in ICU (positive CAM-ICU).

You may not qualify if…

• Cancer diagnosis with short life expectancy determined by the Primary Care Provider (unable to complete the study within time frame)
• Chemotherapy (drug-induced impaired cognition)
• Diagnosed vascular dementia or other neurodegenerative diseases (e.g. Alzheimer or Parkinson disease)
• Documented alcohol consumption ≥5 drinks/day (withdrawal delirium tremens)
• Corrected vision<20/80 Snellen chart (unable to do cognitive exercises on the tablet)
• Examiner rated low hearing or communicative ability that would interfere with intervention and assessments
• Positive CAM-ICU (delirium) at hospital discharge
• Unable to participate in rehabilitation (abnormal 6 min walk test)
• Any physical condition preventing recumbent cycling
• Recent documented history of drug abuse.

Where it is running

• St. Luke's Hospital of Kansas City — Kansas City, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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