Simultaneous Recumbent Cycling and Cognitive Training on Cognition in Intensive Care Unit Survivors: a Randomized Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 64
Healthy Volunteers: f
View:

• 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).

Locations
United States
Missouri
St. Luke's Hospital of Kansas City
RECRUITING
Kansas City
Contact Information
Primary
Rita S Lasiter, PhD
LasiterR@umkc.edu
816-235-6766
Backup
Matthew S Chrisman, PhD
chrismanms@umkc.edu
816-235-5709
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Simultaneous Cycle/Cognitive Training
After discharge from the hospital the group will engage in recumbent cycling with simultaneous cognitive training on a tablet.
No_intervention: Usual Care
After discharge from the hospital the group will complete baseline activies.
Related Therapeutic Areas
Sponsors
Collaborators: St. Luke's Hospital, Kansas City, Missouri
Leads: University of Missouri, Kansas City

This content was sourced from clinicaltrials.gov