RECRUITING

Simultaneous Recumbent Cycling and Cognitive Training

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-03
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04556227

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 45-64 years
  2. * Admitted to medical or surgical ICUs (SLH \& TMC) for \>24 hours
  3. * English-speaking
  4. * Discharged home
  5. * Able to provide consent
  6. * Access to a telephone
  7. * One or more delirium episode in ICU (positive CAM-ICU).
  1. * Cancer diagnosis with short life expectancy determined by the Primary Care Provider (unable to complete the study within time frame)
  2. * Chemotherapy (drug-induced impaired cognition)
  3. * Diagnosed vascular dementia or other neurodegenerative diseases (e.g. Alzheimer or Parkinson disease)
  4. * Documented alcohol consumption ≥5 drinks/day (withdrawal delirium tremens)
  5. * Corrected vision\<20/80 Snellen chart (unable to do cognitive exercises on the tablet)
  6. * Examiner rated low hearing or communicative ability that would interfere with intervention and assessments
  7. * Positive CAM-ICU (delirium) at hospital discharge
  8. * Unable to participate in rehabilitation (abnormal 6 min walk test)
  9. * Any physical condition preventing recumbent cycling
  10. * Recent documented history of drug abuse.

Contacts and Locations

Study Contact

Rita S Lasiter, PhD
CONTACT
816-235-6766
LasiterR@umkc.edu
Matthew S Chrisman, PhD
CONTACT
816-235-5709
chrismanms@umkc.edu

Principal Investigator

Rita S Lasiter, PhD
PRINCIPAL_INVESTIGATOR
University of Missouri, Kansas City
Matthew S Chrisman, PhD
PRINCIPAL_INVESTIGATOR
University of Missouri, Kansas City

Study Locations (Sites)

St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States

Collaborators and Investigators

Sponsor: University of Missouri, Kansas City

  • Rita S Lasiter, PhD, PRINCIPAL_INVESTIGATOR, University of Missouri, Kansas City
  • Matthew S Chrisman, PhD, PRINCIPAL_INVESTIGATOR, University of Missouri, Kansas City

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-03
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-12-03
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Intensive Care Unit
  • ICU-Survivors
  • Cognitive Training
  • Recumbent Cycling
  • Executive Functioning

Additional Relevant MeSH Terms

  • Delirium
  • Impaired Cognition