Simultaneous Recumbent Cycling and Cognitive Training

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-64
SponsorUniversity of Missouri, Kansas City

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 45-64 years

Admitted to medical or surgical ICUs (SLH & TMC) for >24 hours

English-speaking

Discharged home

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Simultaneous Cycle/Cognitive Training

    Behavioral

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Simultaneous Cycle/Cognitive TrainingExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Feasibility of Simultaneous Recumbent Cycling and Cognitive Training Survey

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.

Time frame
At study completion, approximately 36 weeks.
2

Acceptability of Simultaneous Recumbent Cycling and Cognitive Training Survey

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

Time frame
Approximately 24 weeks.

Secondary outcomes

1

Change in Cognition using Montreal Cognitive Assessment Test

Cognitive status assessed at multiple data collection points using the Montreal Cognitive Assessment Test. The following composite scores may be used to grade severity: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment.

Time frame
Screening for inclusion, 2 weeks,12 weeks, 24 weeks, and at study completion, approximately 36 weeks.
2

Change in perceived cognition using Patient-Reported Outcomes Measurement Information System, Applied Cognition Short Form-8.

Participants' perception of daily cognition using the Patient-Reported Outcomes Measurement Information System (PROMIS), Applied Cognition Short Form-8 item and composite scores; higher score means better outcome.

Time frame
Baseline,12 weeks, 24 weeks, and at study completion, approximately 36 weeks.
3

Quality of life using Patient-Reported Outcomes Measurement Information System Global-10 Short Form

Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Short Form used to measure physical, mental, and social health quality of life. Item and composite score; higher score means better outcome.

Time frame
Baseline,12 weeks, and at study completion, approximately 36 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Missouri, Kansas City

Lead sponsor

St. Luke's Hospital, Kansas City, Missouri

Collaborator