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

Amnestic Mild Cognitive Impairment Clinical Trial

— mSIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04185298
• Other study ID #: 20191298
• Secondary ID: R21AG061494
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: April 17, 2023

Study information

• Verified date: August 2023
• Source: Saint John's Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 17, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amnestic Mild Cognitive Impairment
• Cognitive Dysfunction

Intervention

Behavioral:
• mSIM intervention plus activity monitoring
Participants will receive the full mSIM intervention and be monitored (via Fitbit)
• Activity monitoring
Participants will have activity monitored (via Fitbit)

Locations

Country	Name	City	State
United States	Pacific Brain Health Center	Santa Monica	California

Sponsors (3)

Lead Sponsor	Collaborator
Jennifer Bramen	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (48)

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Memory Function Composite Score	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
Primary	Functional Abilities	Assessed using the Multifactorial Memory Questionnaire (MMQ)	Baseline, approximately 3 months and approximately 6 months
Secondary	Resting brain-derived neurotrophic factor (BDNF)	Resting level of serum-derived BDNF	Baseline and approximately 6 months
Secondary	Resting norepinephrine (NE)	Resting level of plasma-derived norepinephrine (NE)	Baseline and approximately 6 months

External Links

•   Multifactorial Memory Questionnaire
•   Rivermead Behavioural Memory Test - Third Edition (RBMT-3)
•   Use of the Functional Activities Questionnaire in Older Adults with Dementia
•   World Health Organization (WHO) definitions