mSIM: Mobile Simultaneous Aerobic Exercise and Memory Training Intervention for Amnestic Mild Cognitive Impairment (mSIM)
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|ClinicalTrials.gov Identifier: NCT04185298|
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : November 26, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Amnestic Mild Cognitive Impairment||Behavioral: mSIM intervention plus activity monitoring Behavioral: Activity monitoring||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Official Title:||Mobile Technology-Based Simultaneous Aerobic Exercise and Memory Training Intervention for Older Adults With Mild Cognitive Impairment|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||November 30, 2021|
Active Comparator: Group 1 (No treatment)
Group 1: Participants will have continuous activity monitoring (via Fitbit)
Behavioral: mSIM intervention plus activity monitoring
Participants will receive the full mSIM intervention and be monitored (via Fitbit)
Experimental: Group 2 (Experimental)
Group 2: Participants will receive the mSIM treatment and have their activity monitored continuously (via Fitbit)
Behavioral: Activity monitoring
Participants will have activity monitored (via Fitbit)
- Memory Function Composite Score [ Time Frame: Baseline, approximately 3 months and approximately 6 months ]Global Z-Score including results from RAVLT (Rey's Auditory Verbal Learning Test), Wechsler Memory Scale Fourth Edition (WMS-IV) Logical Memory and Visual Reproduction tests.
- Functional Abilities [ Time Frame: Baseline, approximately 3 months and approximately 6 months ]Assessed using the Multifactorial Memory Questionnaire (MMQ)
- Resting brain-derived neurotrophic factor (BDNF) [ Time Frame: Baseline and approximately 6 months ]Resting level of serum-derived BDNF
- Resting norepinephrine (NE) [ Time Frame: Baseline and approximately 6 months ]Resting level of plasma-derived norepinephrine (NE)
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): NCT04185298
|Contact: Jennifer Bramen, PhDemail@example.com|
|Contact: Sarah McEwen, PhDfirstname.lastname@example.org|
|Principal Investigator:||Jennifer Bramen, PhD||Saint John's Cancer Institute|