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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Amnestic Mild Cognitive Impairment Behavioral: mSIM intervention plus activity monitoring Behavioral: Activity monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Mobile Technology-Based Simultaneous Aerobic Exercise and Memory Training Intervention for Older Adults With Mild Cognitive Impairment
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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.

  2. Functional Abilities [ Time Frame: Baseline and 17-weeks ]
    Assessed using the Functional Activities Questionnaire (FAQ)


Secondary Outcome Measures :
  1. Resting brain-derived neurotrophic factor (BDNF) [ Time Frame: Baseline and 17-weeks ]
    Resting level of serum BDNF

  2. Resting norepinephrine (NE) [ Time Frame: Baseline and 17-weeks ]
    Resting level of Salivary alpha-amylase activity (sAA) -derived norepinephrine



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185298


Contacts
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Contact: Sarah McEwen, PhD 310-738-1551 sarah.mcewen@providence.org
Contact: Jennifer Bramen, PhD 310-829-8043 jennifer.bramen@providence.org

Locations
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United States, California
Pacific Brain Health Center Recruiting
Santa Monica, California, United States, 90404
Contact: Jennifer Bramen, PhD    310-829-8043    jbramen@pacificneuro.org   
Contact: David H Merrill, MD, PhD    (310) 582-7641    david.merrill@providence.org   
Sponsors and Collaborators
John Wayne Cancer Institute
Additional Information:
Publications:

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Responsible Party: John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT04185298    
Other Study ID Numbers: 20191298
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders