Recruiting

Cycling & Cognitive Training

Sponsor:

University of Missouri, Kansas City

Code:

NCT04556227

Conditions

Delirium

Impaired Cognition

Eligibility Criteria

Sex: All

Age: 45 - 64

Healthy Volunteers: Not accepted

Interventions

Simultaneous Cycle/Cognitive Training

Study Details

Brief summary:

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

Delirium

Impaired Cognition

Study ID

NCT04556227

Start date

Dec 3, 2024

Status verified date

Dec, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 64

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Simultaneous Cycle/Cognitive Training

After discharge from the hospital the group will engage in recumbent cycling with simultaneous cognitive training on a tablet.

no intervention: Usual Care

After discharge from the hospital the group will complete baseline activies.

Interventions

Simultaneous Cycle/Cognitive Training

Two weeks after discharge from the hospital the intervention group will complete recumbent cycle for 1 hour, 2x/wk. for 12 weeks (24 sessions). 10-minute cycle warm-up, 40-minute simultaneous cycling and cognitive training, 10-minute cool down. Cycling based on provider prescription and progression of physical recovery. Cognitive training program from Posit Science, Brain HQ (TM) progressive level of difficulty. Total duration of 60 minutes.

Primary outcome measure

  • Feasibility of Simultaneous Recumbent Cycling and Cognitive Training Survey [ Time Frame: At study completion, approximately 36 weeks. ]
  • Acceptability of Simultaneous Recumbent Cycling and Cognitive Training Survey [ Time Frame: Approximately 24 weeks. ]

Central Contacts and Locations

Central contacts

Matthew S Chrisman, PhD

816-235-5709chrismanms@umkc.edu

Locations

St. Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Matthew S Chrisman, PhD

(816) 235-5709chrismanms@umkc.edu

More Information

Sponsor

University of Missouri, Kansas City

Last update posted

Dec 6, 2024

Last verified

Dec, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri, Kansas City on 2024-12-06.