Simultaneous Recumbent Cycling and Cognitive Training
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04556227|
Recruitment Status : Not yet recruiting
First Posted : September 21, 2020
Last Update Posted : September 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Delirium Impaired Cognition||Behavioral: Simultaneous Cycle/Cognitive Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Rita S Lasiter, PhD||816-235-6766||LasiterR@umkc.edu|
|Contact: Matthew S Chrisman, PhDemail@example.com|
|United States, Missouri|
|Truman Medical Center|
|Kansas City, Missouri, United States, 64108|
|Contact: Rita S Lasiter, PhD 816-235-6766 firstname.lastname@example.org|
|St. Luke's Hospital of Kansas City|
|Kansas City, Missouri, United States, 64111|
|Contact: Matthew S Chrisman, PhD 816-235-5709 email@example.com|
|Principal Investigator:||Rita S Lasiter, PhD||University of Missouri, Kansas City|
|Principal Investigator:||Matthew S Chrisman, PhD||University of Missouri, Kansas City|