NCT04185298

mSIM: Mobile Simultaneous Aerobic Exercise and Memory Training Intervention for Amnestic Mild Cognitive Impairment

Mobile Technology-Based Simultaneous Aerobic Exercise and Memory Training Intervention for Older Adults With Mild Cognitive Impairment

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Jennifer Bramen · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amnestic Mild Cognitive Impairment

Interventions

Type	Name	Description
BEHAVIORAL	mSIM intervention plus activity monitoring	Participants will receive the full mSIM intervention and be monitored (via Fitbit)
BEHAVIORAL	Activity monitoring	Participants will have activity monitored (via Fitbit)

Timeline

• Start date: 2019-10-01
• Primary completion: 2023-04-17
• Completion: 2023-04-17
• First posted: 2019-12-04
• Last updated: 2025-01-14
• Results posted: 2025-01-14

Locations

1 site across 1 country: United States