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

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ClinicalTrials.gov Identifier: NCT04185298
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
John Wayne Cancer Institute

Tracking Information
First Submitted Date  ICMJE December 2, 2019
First Posted Date  ICMJE December 4, 2019
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • Memory Function Composite Score [ Time Frame: Baseline and 17-weeks ]
    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 [ Time Frame: Baseline and 17-weeks ]
    Assessed using the Functional Activities Questionnaire (FAQ)
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
  • Increased Memory Function Composite Score [ Time Frame: Baseline and 17-weeks ]
    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.
  • Increased functional abilities [ Time Frame: Baseline and 17-weeks ]
    Assessed using the Functional Activities Questionnaire (FAQ)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • Resting brain-derived neurotrophic factor (BDNF) [ Time Frame: Baseline and 17-weeks ]
    Resting level of serum BDNF
  • Resting norepinephrine (NE) [ Time Frame: Baseline and 17-weeks ]
    Resting level of Salivary alpha-amylase activity (sAA) -derived norepinephrine
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
  • Increased resting brain-derived neurotrophic factor (BDNF) [ Time Frame: Baseline and 17-weeks ]
    Resting level of serum BDNF
  • Increased resting norepinephrine (NE) [ Time Frame: Baseline and 17-weeks ]
    Resting level of Salivary alpha-amylase activity (sAA) -derived norepinephrine
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE mSIM: Mobile Simultaneous Aerobic Exercise and Memory Training Intervention for Older Adults With Amnestic Mild Cognitive Impairment
Official Title  ICMJE Mobile Technology-Based Simultaneous Aerobic Exercise and Memory Training Intervention for Older Adults With Mild Cognitive Impairment
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 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. 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 participants 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 weeks of an exercise ramp-up (2x/week for 30 minutes) where they will increase their aerobic intensity from 50% by 5% each session until they reach 65% HRR and can sustain that heart rate for 40 minutes, which will be the intensity for the training. 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 and 17 weeks. Concentration levels of peripheral biomarkers BDNF and NE at baseline and after 17 -weeks will also be assessed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Amnestic Mild Cognitive Impairment
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Active Comparator: Group 1 (No treatment)
    Group 1: Participants will have continuous activity monitoring (via Fitbit)
    Intervention: Behavioral: mSIM intervention plus activity monitoring
  • Experimental: Group 2 (Experimental)
    Group 2: Participants will receive the mSIM treatment and have their activity monitored continuously (via Fitbit)
    Intervention: Behavioral: Activity monitoring
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Subjects must be age 50 to 80 at time of informed consent.
  • Subjects must have undergone an evaluation, including clinical assessment to confirm aMCI diagnosis as part of their ongoing medical treatment within 6 months of enrollment to this study.
  • Subjects of any gender, race or ethnicity are eligible to enroll in the study.
  • 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.
  • If subjects at screening answers "yes" to any question on the PAR-Q, they will need to obtain clearance from a physician to participate in a moderate aerobic exercise. program, which was a sufficient safety measure employed in our pilot SIM study.
  • 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 wifi 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.

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: cardiovascular, respiratory, illness or injury, substance abuse, schizophrenia, bipolar disorder, or other neurological diseases.
  • Subjects must not have a Mini Mental State Exam (MMSE) below 19.
  • Subjects must not have a Clinical Dementia Rating (CDR) global score of 2 or above 2.
  • Subjects must not have a Montreal Cognitive Assessment (MoCA)42 score of below 20 or during their baseline evaluation.
  • Subjects must not demonstrate a progression of aMCI to dementia at baseline based on the best judgement of a study Clinical Neuropsychologist.
  • Subjects must not answer in the affirmative to any PAR-Q questionnaire and be unable to provide medical clearance from their physician.
  • Subjects must not be unable to pass the cardiovascular fitness test during their baseline evaluation.
  • Subjects must not have EKG abnormalities found during the subject's baseline evaluation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah McEwen, PhD 310-738-1551 sarah.mcewen@providence.org
Contact: Jennifer Bramen, PhD 310-829-8043 jennifer.bramen@providence.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04185298
Other Study ID Numbers  ICMJE 20191298
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Wayne Cancer Institute
Study Sponsor  ICMJE John Wayne Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account John Wayne Cancer Institute
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP