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

Primary Purpose

Amnestic Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mSIM intervention plus activity monitoring
Activity monitoring
Sponsored by
Jennifer Bramen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amnestic Mild Cognitive Impairment

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pacific Brain Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1 (No treatment)

Group 2 (Experimental)

Arm Description

Group 1: Participants will have continuous activity monitoring (via Fitbit)

Group 2: Participants will receive the mSIM treatment and have their activity monitored continuously (via Fitbit)

Outcomes

Primary Outcome Measures

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.
Functional Abilities
Assessed using the Multifactorial Memory Questionnaire (MMQ)

Secondary Outcome Measures

Resting brain-derived neurotrophic factor (BDNF)
Resting level of serum-derived BDNF
Resting norepinephrine (NE)
Resting level of plasma-derived norepinephrine (NE)

Full Information

First Posted
December 2, 2019
Last Updated
August 31, 2023
Sponsor
Jennifer Bramen
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04185298
Brief Title
mSIM: Mobile Simultaneous Aerobic Exercise and Memory Training Intervention for Amnestic Mild Cognitive Impairment
Acronym
mSIM
Official Title
Mobile Technology-Based Simultaneous Aerobic Exercise and Memory Training Intervention for Older Adults With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
April 17, 2023 (Actual)
Study Completion Date
April 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jennifer Bramen
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amnestic Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (No treatment)
Arm Type
Active Comparator
Arm Description
Group 1: Participants will have continuous activity monitoring (via Fitbit)
Arm Title
Group 2 (Experimental)
Arm Type
Experimental
Arm Description
Group 2: Participants will receive the mSIM treatment and have their activity monitored continuously (via Fitbit)
Intervention Type
Behavioral
Intervention Name(s)
mSIM intervention plus activity monitoring
Intervention Description
Participants will receive the full mSIM intervention and be monitored (via Fitbit)
Intervention Type
Behavioral
Intervention Name(s)
Activity monitoring
Intervention Description
Participants will have activity monitored (via Fitbit)
Primary Outcome Measure Information:
Title
Memory Function Composite Score
Description
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.
Time Frame
Baseline, approximately 3 months and approximately 6 months
Title
Functional Abilities
Description
Assessed using the Multifactorial Memory Questionnaire (MMQ)
Time Frame
Baseline, approximately 3 months and approximately 6 months
Secondary Outcome Measure Information:
Title
Resting brain-derived neurotrophic factor (BDNF)
Description
Resting level of serum-derived BDNF
Time Frame
Baseline and approximately 6 months
Title
Resting norepinephrine (NE)
Description
Resting level of plasma-derived norepinephrine (NE)
Time Frame
Baseline and approximately 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Bramen, PhD
Organizational Affiliation
Saint John's Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Brain Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

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PubMed Identifier
17014981
Citation
Gualtieri CT, Johnson LG. Reliability and validity of a computerized neurocognitive test battery, CNS Vital Signs. Arch Clin Neuropsychol. 2006 Oct;21(7):623-43. doi: 10.1016/j.acn.2006.05.007. Epub 2006 Oct 2.
Results Reference
background
Links:
URL
http://www.who.int/mediacentre/factsheets/fs362/en/
Description
World Health Organization (WHO) definitions
URL
https://www.pearsonclinical.co.uk/Psychology/AdultCognitionNeuropsychologyandLanguage/AdultMemory/RivermeadBehaviouralMemoryTestThirdEditionRBMT3/RivermeadBehaviouralMemoryTestThirdEditionRBMT3.aspx
Description
Rivermead Behavioural Memory Test - Third Edition (RBMT-3)
URL
https://www.alz.org/careplanning/downloads/functional-activities-questionnaire.pdf
Description
Use of the Functional Activities Questionnaire in Older Adults with Dementia
URL
https://www.baycrest.org/Baycrest_Centre/media/content/form_files/MMQ-Manual-2018_ebook.pdf
Description
Multifactorial Memory Questionnaire

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

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