Actively Recruiting

Phase Not Applicable
Age: 45Years - 64Years
All Genders
NCT04556227

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

Age: 45Years - 64Years
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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

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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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