mSIM: Mobile Simultaneous Aerobic Exercise and Memory Training Intervention for Amnestic Mild Cognitive Impairment
NCT ID: NCT04185298
Last Updated: 2025-01-14
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
12 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-10-01
Study Completion Date
2023-04-17
Brief Summary
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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.
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Detailed Description
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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 John's 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 Subject's 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 subject's treating physician, will be obtained from each participant prior to enrolling in the study. A copy of all signed ICF's 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 (2x/week) 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 sessions/week. 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 John's 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 Subject's 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 subject's treating physician, will be obtained from each participant prior to enrolling in the study. A copy of all signed ICF's 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 (2x/week) 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 sessions/week. 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.
Conditions
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Amnestic Mild Cognitive Impairment
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The study will include two arms: Arm 1: activity monitoring only control (CON), Arm 2: active intervention with mSIM program (mSIM) plus activity monitoring (via Fitbit), to evaluate the efficacy of the mSIM intervention on memory performance and everyday functioning. The 'Activity monitoring only' arm will serve as the control group. Study objectives include measuring treatment related changes in memory performance and everyday functioning along with putative biomarkers of the behavioral changes.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Group 1 (No treatment)
Group 1: Participants will have continuous activity monitoring (via Fitbit)
Group Type
ACTIVE_COMPARATOR
mSIM intervention plus activity monitoring
Intervention Type
BEHAVIORAL
Participants will receive the full mSIM intervention and be monitored (via Fitbit)
Group 2 (Experimental)
Group 2: Participants will receive the mSIM treatment and have their activity monitored continuously (via Fitbit)
Group Type
EXPERIMENTAL
Activity monitoring
Intervention Type
BEHAVIORAL
Participants will have activity monitored (via Fitbit)
Interventions
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mSIM intervention plus activity monitoring
Participants will receive the full mSIM intervention and be monitored (via Fitbit)
Intervention Type
BEHAVIORAL
Activity monitoring
Participants will have activity monitored (via Fitbit)
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Subjects must be age 50 to 80 at time of informed consent.
* Subjects must confirm an aMCI diagnosis either by providing records from a clinical assessment within 6 months of enrollment in this study or through a brief memory assessment by study staff at screening.
* Subjects must be proficient in spoken and written English for consenting as well as for study participation since the intervention in this study is currently only available in English.
* Subjects with medical conditions must be stable for these conditions. Stable control on medication is acceptable.
* Subjects, with or without assistance, must be able to use a computer and web interface. If assistance is needed, it must be readily available to them.
* Subjects are required to have internet with Wi-Fi at the location of their mSIM training.
* Subject must have normal visual acuity (or corrected to normal) and normal color vision as indicated by self-report.
* Subject must have adequate hearing acuity as indicated by self-report.
* Subject must have adequate motor capacity to use a mobile phone/iPad/computer as indicated by self-report.
* Subjects must be able to provide medical clearance to participate in an unsupervised, moderate intensity exercise program from a physician.
* Subjects must confirm an aMCI diagnosis either by providing records from a clinical assessment within 6 months of enrollment in this study or through a brief memory assessment by study staff at screening.
* Subjects must be proficient in spoken and written English for consenting as well as for study participation since the intervention in this study is currently only available in English.
* Subjects with medical conditions must be stable for these conditions. Stable control on medication is acceptable.
* Subjects, with or without assistance, must be able to use a computer and web interface. If assistance is needed, it must be readily available to them.
* Subjects are required to have internet with Wi-Fi at the location of their mSIM training.
* Subject must have normal visual acuity (or corrected to normal) and normal color vision as indicated by self-report.
* Subject must have adequate hearing acuity as indicated by self-report.
* Subject must have adequate motor capacity to use a mobile phone/iPad/computer as indicated by self-report.
* Subjects must be able to provide medical clearance to participate in an unsupervised, moderate intensity exercise program from a physician.
Exclusion Criteria
* Subjects must not have an existing diagnosis of a neurodegenerative disorder (e.g., Alzheimer's Disease, Lewy Body Dementia, Frontal-Temporal Dementia).
* Subjects must not have a prior diagnosis that might impact cognition and movement abilities including: significant cardiovascular disease, significant respiratory disease, illness or injury, substance abuse, schizophrenia, bipolar disorder, or other neurological diseases.
* Subjects must not have a previous Mini Mental State Exam (MMSE) score below 19.
* Subjects must not have a previous Clinical Dementia Rating (CDR) global score of ≥2.
* Subjects must not have a Montreal Cognitive Assessment (MoCA)43 score of below 18 previously or during their screening evaluation.
* Subjects must not demonstrate a progression of aMCI to dementia at screening based on the best judgement of a study Clinical Neuropsychologist.
* Subjects must not currently participate in a high level of physical activity prior to study start as assessed by the International Physical Activity Questionnaire (IPAQ) at screening.
* Subjects must not endorse that they are unable to participate in moderate intensity aerobic activities, such as fast walking or passing/kicking a ball to a partner at screening.
* Subjects must not have a prior diagnosis that might impact cognition and movement abilities including: significant cardiovascular disease, significant respiratory disease, illness or injury, substance abuse, schizophrenia, bipolar disorder, or other neurological diseases.
* Subjects must not have a previous Mini Mental State Exam (MMSE) score below 19.
* Subjects must not have a previous Clinical Dementia Rating (CDR) global score of ≥2.
* Subjects must not have a Montreal Cognitive Assessment (MoCA)43 score of below 18 previously or during their screening evaluation.
* Subjects must not demonstrate a progression of aMCI to dementia at screening based on the best judgement of a study Clinical Neuropsychologist.
* Subjects must not currently participate in a high level of physical activity prior to study start as assessed by the International Physical Activity Questionnaire (IPAQ) at screening.
* Subjects must not endorse that they are unable to participate in moderate intensity aerobic activities, such as fast walking or passing/kicking a ball to a partner at screening.
Minimum Eligible Age
50 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
National Institute on Aging (NIA)
NIH
Sponsor Role
collaborator
Jennifer Bramen
OTHER
Sponsor Role
lead
Responsible Party
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Jennifer Bramen
Assistant Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Jennifer Bramen, PhD
Role: PRINCIPAL_INVESTIGATOR
Saint John's Cancer Institute
Locations
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Pacific Brain Health Center
Santa Monica, California, United States
Site Status
Countries
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United States
References
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BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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http://www.who.int/mediacentre/factsheets/fs362/en/
World Health Organization (WHO) definitions
https://www.pearsonclinical.co.uk/Psychology/AdultCognitionNeuropsychologyandLanguage/AdultMemory/RivermeadBehaviouralMemoryTestThirdEditionRBMT3/RivermeadBehaviouralMemoryTestThirdEditionRBMT3.aspx
Rivermead Behavioural Memory Test - Third Edition (RBMT-3)
https://www.alz.org/careplanning/downloads/functional-activities-questionnaire.pdf
Use of the Functional Activities Questionnaire in Older Adults with Dementia
https://www.baycrest.org/Baycrest_Centre/media/content/form_files/MMQ-Manual-2018_ebook.pdf
Multifactorial Memory Questionnaire
Other Identifiers
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20191298
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
NA
Non-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia
NCT05661084
RECRUITING
NA
Effects of Mental Stimulation in Patients With Mild Cognitive Impairment
NCT01212692
COMPLETED
PHASE2
Walking on Cognitive Function in Individuals With Mild Cognitive Impairment: A Pilot Project
NCT04498195
COMPLETED
NA
Working Memory and Physical Exercise Training in Patients With Mild Cognitive Impairment
NCT05948930
RECRUITING
NA
UCLA Fitness and Memory Study of Activity In Mild Cognitive Impairment (AIM)
NCT02001441
COMPLETED
A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment
NCT06355973
NOT_YET_RECRUITING
NA
Electronic Memory and Management Aid
NCT05696756
UNKNOWN
NA
Memory Support System for Older Chinese Americans With Mild Cognitive Impairment
NCT07142499
RECRUITING
NA
Improve New Learning and Memory in Individuals With Mild Cognitive Impairment
NCT05396248
RECRUITING
NA
A Mobile Informatics Solution to Aid in Memory
NCT04700540
COMPLETED
NA
The Active Mind Study
NCT03289546
COMPLETED
NA
Combating Alzheimer's Through Sleep and Exercise
NCT04855630
RECRUITING
NA
The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia
NCT04171323
RECRUITING
NA
Walking After Traumatic Brain Injury in Older Adults
NCT06222502
COMPLETED
NA
A Comparison of the Effectiveness of Two Types of Memory Training Programs in People With a Diagnosis of Mental Illness.
NCT01708200
UNKNOWN
NA
Body and Brain Exercise for Older Adults With Memory Complaints
NCT02136368
COMPLETED
NA
Using Exercise and Electrical Brain Stimulation to Improve Memory in Dementia
NCT03670615
COMPLETED
NA
Mild Cognitive Impairment Community Screening and Early Intervention Via Stem Cell Therapy and Wearable Brain Computer Interface Device.
NCT07214974
NOT_YET_RECRUITING
EARLY_PHASE1
Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease
NCT00743418
UNKNOWN
PHASE1/PHASE2
A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)
NCT02592187
UNKNOWN
NA
A Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment
NCT01962038
COMPLETED
NA
Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment
NCT02785315
COMPLETED
NA
Movement Intervention for Memory Enhancement
NCT03475316
COMPLETED
NA
Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment
NCT02155946
COMPLETED
NA