Combining cycling and cognitive training for ICU survivors
Simultaneous Recumbent Cycling and Cognitive Training on Cognition in Intensive Care Unit Survivors: a Randomized Control Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 45 Years to 64 Years |
| Sex | All |
| Sponsor | University of Missouri, Kansas City Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT04556227 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe cognitive impairments, neurodegenerative diseases, or conditions that prevent participation in rehabilitation will not benefit from this study.
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 performed: While the combination of physical exercise and cognitive training is emerging, this specific approach has not been extensively tested in similar populations.
Eligibility criteria
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 this trial is running
Kansas City, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.