Simultaneous Recumbent Cycling and Cognitive Training for Delirium Survivors

This study is looking at a program called Simultaneous Recumbent Cycling and Cognitive Training (SRCCT) for people aged 45-64 who had delirium (a state of confusion) while in the Intensive Care Unit (ICU). The program involves cycling on a special bike for an hour, twice a week for 12 weeks, while also doing brain training exercises on a computer. The goal is to see if this program is practical and acceptable to participants, and if it can help improve thinking skills and quality of life after leaving the hospital. To join, you must have been in the ICU for over 24 hours, speak English, and have experienced delirium. The study aims to enroll 50 participants.

Study design
This is an interventional study comparing Simultaneous Recumbent Cycling and Cognitive Training to usual care. It is a pilot study designed to assess feasibility and acceptability, and plans to enroll 50 participants.
What's involved
If you join the intervention group, you would complete 24 sessions of recumbent cycling and cognitive training over 12 weeks. Each session lasts one hour.
Compensation
Not stated in the trial record.
Follow-up
Your feasibility will be measured at approximately 36 weeks, and acceptability at approximately 24 weeks after the study begins.

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NCT04556227

Simultaneous Recumbent Cycling and Cognitive Training

Recruiting
NAAges 45–64InterventionalSupportive care
University of Missouri, Kansas City
~50 participants
Updated 2024-12-06 on ClinicalTrials.gov
What's tested:Simultaneous Cycle/Cognitive Training

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Simultaneous Recumbent Cycling and Cognitive Training Survey
Measured over At study completion, approximately 36 weeks.
+1 more outcome measured
Delirium
Impaired Cognition
1 sites across 1 states
Missouri1
  • Rita S Lasiter, PhD · PRINCIPAL_INVESTIGATOR · University of Missouri, Kansas City
  • Matthew S Chrisman, PhD · PRINCIPAL_INVESTIGATOR · University of Missouri, Kansas City

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Eligibility criteria

Inclusion

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

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.
  • Feasibility of Simultaneous Recumbent Cycling and Cognitive Training SurveyAt study completion, approximately 36 weeks.

    Feasibility of participant recruitment, randomization, intervention, intervention fidelity, and data collection. Less problems to overcome with recruitment, randomization, administering intervention, and data collection the more feasible the study.

  • Acceptability of Simultaneous Recumbent Cycling and Cognitive Training SurveyApproximately 24 weeks.

    Acceptability Survey: Determine satisfaction and burden including text suggestions for study improvement. Likert type scale 1-4; higher score means more acceptable.