mSIM: Mobile Simultaneous Aerobic Exercise and Memory Training Intervention for Amnestic Mild Cognitive Impairment
Condition: Amnestic Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

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.
    

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 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.
    

Intervention name(s): mSIM intervention plus activity monitoring; Activity monitoring
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive the full mSIM intervention and be monitored (via Fitbit); Participants will have activity monitored (via Fitbit)
Allocation: Randomized
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)
Primary purpose: Treatment