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Simultaneous Recumbent Cycling and Cognitive Training

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ClinicalTrials.gov Identifier: NCT04556227
Recruitment Status : Not yet recruiting
First Posted : September 21, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborators:
American Association of Critical-Care Nurses
Truman Medical Center
St. Luke's Hospital, Kansas City, Missouri
Information provided by (Responsible Party):
Rita Sue Lasiter, University of Missouri, Kansas City

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.

Condition or disease Intervention/treatment Phase
Delirium Impaired Cognition Behavioral: Simultaneous Cycle/Cognitive Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Upon leaving ICU and admission to general hospital room, study staff will go to patients' room to recruit and consent ICU survivor for study start date approximately two weeks after discharge. Randomize study participant using block randomization program. Document data on patients who decline consent and wish to be randomized to usual care or to the intervention group. This is a single masked (participant) study.
Primary Purpose: Supportive Care
Official Title: Simultaneous Recumbent Cycling and Cognitive Training on Cognition in Intensive Care Unit Survivors: A Randomized Control Trial
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Simultaneous Cycle/Cognitive Training
After discharge from the hospital the group will engage in recumbent cycling with simultaneous cognitive training on a tablet.
Behavioral: 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.

No Intervention: Usual Care
After discharge from the hospital the group will complete baseline activies.



Primary Outcome Measures :
  1. Feasibility of Simultaneous Recumbent Cycling and Cognitive Training Survey [ Time Frame: At 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.

  2. Acceptability of Simultaneous Recumbent Cycling and Cognitive Training Survey [ Time Frame: Approximately 24 weeks. ]
    Acceptability Survey: Determine satisfaction and burden including text suggestions for study improvement. Likert type scale 1-4; higher score means more acceptable.


Secondary Outcome Measures :
  1. Change in Cognition using Montreal Cognitive Assessment Test [ Time Frame: Screening for inclusion, 2 weeks,12 weeks, 24 weeks, and at study completion, approximately 36 weeks. ]
    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.

  2. Change in perceived cognition using Patient-Reported Outcomes Measurement Information System, Applied Cognition Short Form-8. [ Time Frame: Baseline,12 weeks, 24 weeks, and at study completion, approximately 36 weeks. ]
    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.

  3. Quality of life using Patient-Reported Outcomes Measurement Information System Global-10 Short Form [ Time Frame: Baseline,12 weeks, and at study completion, approximately 36 weeks. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556227


Contacts
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Contact: Rita S Lasiter, PhD 816-235-6766 LasiterR@umkc.edu
Contact: Matthew S Chrisman, PhD 816-235-5709 chrismanms@umkc.edu

Locations
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United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
Contact: Rita S Lasiter, PhD    816-235-6766    lasiterr@umkc.edu   
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Contact: Matthew S Chrisman, PhD    816-235-5709    chrismanms@umkc.edu   
Sponsors and Collaborators
University of Missouri, Kansas City
American Association of Critical-Care Nurses
Truman Medical Center
St. Luke's Hospital, Kansas City, Missouri
Investigators
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Principal Investigator: Rita S Lasiter, PhD University of Missouri, Kansas City
Principal Investigator: Matthew S Chrisman, PhD University of Missouri, Kansas City
Publications:
Utilization of Intensive Care Services, 2011 #185. https://hcup-us.ahrq.gov/reports/statbriefs/sb185-Hospital-Intensive-Care-Units-2011.jsp. Accessed September 2, 2019.
Lasiter S, Snodgrass B, Thompson M, Chrisman M. Physical activity and cognitive training as interventions to enhance cognitive functioning: A systematic review. unpublished manuscript.
Leavell HR, Clark EG. Textbook of Preventive Medicine. New York: McGraw-Hill; 1953
Leavell HR, Clark EG. Preventive Medicine for the Doctor in His Community, An Epidemiological Approach. 2nd ed. New York: McGraw-Hill; 1958.
PROMIS: Clinical Outcomes Assessment. https://commonfund.nih.gov/promis/index. Accessed September 7, 2019.

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Responsible Party: Rita Sue Lasiter, Associate Professor, University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT04556227    
Other Study ID Numbers: 40007
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rita Sue Lasiter, University of Missouri, Kansas City:
Intensive Care Unit
ICU-Survivors
Cognitive Training
Recumbent Cycling
Executive Functioning
Additional relevant MeSH terms:
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Delirium
Cognitive Dysfunction
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders