Ignite Creation Date:
2024-05-06 @ 2:00 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04185298
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2019-12-02
Brief Title:
mSIM Mobile Simultaneous Aerobic Exercise and Memory Training Intervention for Amnestic Mild Cognitive Impairment
Sponsor:
Jennifer Bramen
Organization:
Saint Johns Cancer Institute
Study Overview
Official Title:
Mobile Technology-Based Simultaneous Aerobic Exercise and Memory Training Intervention for Older Adults With Mild Cognitive Impairment
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mSIM
Brief Summary:
The mSIM study involves developing and conducting feasibility testing of a web-based application that will deliver mobile-based simultaneous exercise and memory skills training program mSIM for amnesic Mild Cognitive Impairment aMCI patients
The randomized control trial RCT will evaluate the efficacy of mSIM on memory performance and everyday functioning using 2 study arms Group 1 activity monitoring control via Fitbit CON vs Group 2 mSIM intervention plus activity monitoring via Fitbit mSIM treatment response will be evaluated using neuropsychological and functional evaluation Concentration levels of peripheral biomarkers Brain-derived neurotrophic factor BDNF and norepinephrine NE also be assessed
The randomized control trial RCT will evaluate the efficacy of mSIM on memory performance and everyday functioning using 2 study arms Group 1 activity monitoring control via Fitbit CON vs Group 2 mSIM intervention plus activity monitoring via Fitbit mSIM treatment response will be evaluated using neuropsychological and functional evaluation Concentration levels of peripheral biomarkers Brain-derived neurotrophic factor BDNF and norepinephrine NE also be assessed
Detailed Description:
The purpose of the study is to create a web-based cognitive compensatory and predominately memory skills training course that is delivered on a mobile device and compatible with use on a stationary bicycle and test its efficacy on memory and functional ability
Participants will be recruited from 1 the Pacific Brain Health Center in Santa Monica which is a high-volume memory-care and dementia outpatient clinic within a large physician medical group affiliated with Providence Saint Johns Health Center 2 advertisement to participants in the local community and 3 establishment of a website landing page that permits interested individuals to contact the trial coordinator Up to five participants will be course beta testers They will receive a truncated version of the course and will provide detailed feedback 30 participants will be randomized into one of two groups Group 1 control arm will have their physical activity levels continuously monitored via Fitbit Participants will receive the Experimental Research Subjects Bill of Rights prior to signing the informed consent form ICF authorization of use and disclosure of protected health information PHI and authorization of medical record release for the subjects treating physician will be obtained from each participant prior to enrolling in the study A copy of all signed ICFs will be given to the participants and the investigator will retain the original
Group 2 active arm will receive the mSIM intervention plus activity monitoring via Fitbit Group 2 will first undergo 2-6 week of an exercise ramp-up 2xweek until they can sustain 40 minutes at 50 heart rate reserve HRR The intensity for mSIM training will be 40-60 HRR After the ramp-up phase the mSIM participants will begin the 12-week intervention comprised of 2 60-minute sessionsweek mSIM treatment response will be evaluated using neuropsychological and functional evaluation Assessments will occur at baseline mid-trial 3-4 months and post-trial 5-6 months Concentration levels of peripheral biomarkers BDNF and NE at baseline and post-trial 5-6 months will also be assessed
Participants will be recruited from 1 the Pacific Brain Health Center in Santa Monica which is a high-volume memory-care and dementia outpatient clinic within a large physician medical group affiliated with Providence Saint Johns Health Center 2 advertisement to participants in the local community and 3 establishment of a website landing page that permits interested individuals to contact the trial coordinator Up to five participants will be course beta testers They will receive a truncated version of the course and will provide detailed feedback 30 participants will be randomized into one of two groups Group 1 control arm will have their physical activity levels continuously monitored via Fitbit Participants will receive the Experimental Research Subjects Bill of Rights prior to signing the informed consent form ICF authorization of use and disclosure of protected health information PHI and authorization of medical record release for the subjects treating physician will be obtained from each participant prior to enrolling in the study A copy of all signed ICFs will be given to the participants and the investigator will retain the original
Group 2 active arm will receive the mSIM intervention plus activity monitoring via Fitbit Group 2 will first undergo 2-6 week of an exercise ramp-up 2xweek until they can sustain 40 minutes at 50 heart rate reserve HRR The intensity for mSIM training will be 40-60 HRR After the ramp-up phase the mSIM participants will begin the 12-week intervention comprised of 2 60-minute sessionsweek mSIM treatment response will be evaluated using neuropsychological and functional evaluation Assessments will occur at baseline mid-trial 3-4 months and post-trial 5-6 months Concentration levels of peripheral biomarkers BDNF and NE at baseline and post-trial 5-6 months will also be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AG061494 | NIH | None | httpsreporternihgovquickSearchR21AG061494 |