Clinical trial Recruiting at 1 site Interventional Ages 45 to 64

Combining cycling and cognitive training for ICU survivors

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

Run by University of Missouri, Kansas City · NCT04556227 · Data updated 2026-11-12

This study is testing whether a 12-week program that combines cycling and brain exercises can help improve thinking skills and quality of life for middle-aged people who have survived an ICU stay with delirium.

Quick facts

Study typeInterventional
Ages45 Years to 64 Years
SexAll
Enrollment50 (estimated)
SponsorUniversity of Missouri, Kansas City
Academic / other
Drugs / interventionsChemotherapy
Locations1 site (Kansas City, Missouri)
StatusRecruiting
StartedDecember 3, 2024
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedDecember 6, 2024
Trial IDNCT04556227 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are English-speaking individuals aged 45-64 who have been admitted to an ICU for more than 24 hours and have experienced at least one episode of delirium.

Probably not a fit

Patients with severe cognitive impairments, neurodegenerative diseases, or conditions that prevent participation in rehabilitation will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of simultaneous recumbent cycling and cognitive training on cognition and quality of life in middle-aged ICU survivors who have experienced delirium. Participants will engage in a 12-week program that combines physical exercise with cognitive tasks, followed by a 6-month maintenance phase. The study will assess cognitive function and quality of life at multiple time points using validated measures. It aims to determine the feasibility and acceptability of this combined intervention in improving outcomes for ICU survivors.

Why it matters

Potential benefit: If successful, this approach could significantly enhance cognitive function and quality of life for ICU survivors suffering from delirium.

How similar studies have gone: While the combination of physical exercise and cognitive training is emerging, this specific approach has not been extensively tested in similar populations.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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's running

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

Study contacts

  • Principal investigator: Rita S Lasiter, PhD — University of Missouri, Kansas City
  • Study coordinator: Rita S Lasiter, PhD
  • Email: LasiterR@umkc.edu
  • Phone: 816-235-6766

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.