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

August 31, 2023 updated by: Jennifer Bramen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Pacific Brain Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, approximately 3 months and approximately 6 months
Functional Abilities
Time Frame: Baseline, approximately 3 months and approximately 6 months
Assessed using the Multifactorial Memory Questionnaire (MMQ)
Baseline, approximately 3 months and approximately 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting brain-derived neurotrophic factor (BDNF)
Time Frame: Baseline and approximately 6 months
Resting level of serum-derived BDNF
Baseline and approximately 6 months
Resting norepinephrine (NE)
Time Frame: Baseline and approximately 6 months
Resting level of plasma-derived norepinephrine (NE)
Baseline and approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jennifer Bramen

Collaborators

National Institutes of Health (NIH)
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Jennifer Bramen, PhD, Saint John's Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

April 17, 2023

Study Completion (Actual)

April 17, 2023

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

December 2, 2019

First Posted (Actual)

December 4, 2019

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20191298
  • R21AG061494 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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