- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05217849
Multi-domain Online Therapeutic Investigation Of Neurocognition (MOTION) (MOTION)
Multi-domain Online Therapeutic Investigation Of Neurocognition
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94121
- VA Health Care System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age ≥ 55 years
- subjective cognitive complaints, defined as self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event
- Montreal Cognitive Assessment (MoCA) score suggestive of Mild Cognitive Impairment (MCI) status (i.e., < 26)
- English language fluency
- Wireless internet connection at home
- Willingness to travel to the San Francisco VA in northern California or UCLA in southern California for in-person assessments at baseline, after the 12-week interventions, and at the 36-week follow-up
- Capacity to provide informed consent or legally authorized representative consent and participant assent.
Exclusion Criteria:
- current or past Axis I psychiatric disorders, or recent unstable medical or neurological disorders
- disabilities that prevent participation in on-line movement classes (e.g., primarily use wheel-chair, severe visual impairment that would limit ability to observe instructor's movement on screen or severe hearing impairment that would limit ability to hear instructor's directions)
- insufficient English proficiency
- limited life expectancy (i.e., enrolled in hospice, metastatic cancer)
- plan to travel for > 1 week during 12-week intervention period
- diagnosis of dementia per the DSM-5
- MoCA score suggestive of dementia (i.e., <17)
- started dementia medication (cholinesterase inhibitor or memantine) in past 3 months or plans to start dementia medication during study period
- planning to start/change any psychoactive medication during study period
- current participation in another research study
- contraindications to magnetic resonance imaging (MRI), including claustrophobia severe enough to prevent MRI examination, presence of ferrometallic objects in the body that would interfere with MRI examination and/or cause a safety risk (e.g., pacemakers, implanted stimulators, pumps)
- prior or current training in with Tai Chi, PLIE, or other mind-body practices
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tai Chi
Participants will engage in 60-minute Tai Chi classes twice a week for 12 weeks.
The classes will be live-streamed over the internet.
Tai Chi is an ancient Chinese system of gentle physical exercise and stretching.
It involves a series of movements performed in a slow, focused manner and accompanied by deep breathing.
|
Tai Chi is an ancient Chinese form of exercise/martial art that involves a series of movements performed in a slow, focused manner and accompanied by deep breathing.
Other Names:
|
Experimental: Gentle, Mindful Movement
Participants will engage in a gentle, mindful movement class twice a week for 12 weeks.
The classes will be one hour long and will be live-streamed over the internet.
The mindful movement classes will combine elements from a wide range of Eastern and Western exercise modalities, including occupational therapy, physical therapy, yoga, tai chi, Feldenkrais, Rosen Method, dance movement therapy and mindfulness meditation.
|
PLIE is a gentle, mindful movement exercise program that integrates elements of Eastern and Western exercise modalities to develop mindful body awareness and enhance social connection.
Other Names:
|
Active Comparator: Health and Wellness Education
Participants will engage in bi-weekly 60 minute sessions of Health and Wellness Education classes.
The classes will be held on-line for 12 weeks.
|
This on-line class will consist of hour-long lectures/talks about various topics related to healthy aging and wellness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Scores
Time Frame: Change from baseline to 1-week post-treatment.
|
The Alzheimer's Disease Assessment Scale-Cognitive Subscale is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia.
ADAS-cog scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment.
|
Change from baseline to 1-week post-treatment.
|
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Scores
Time Frame: Change from baseline to 6 months after treatment ends.
|
The Alzheimer's Disease Assessment Scale-Cognitive Subscale is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia.
ADAS-cog scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment.
|
Change from baseline to 6 months after treatment ends.
|
Change in Default Mode Network (DMN) functional connectivity
Time Frame: Change from baseline to 1-week post-treatment.
|
The default mode network (DMN) is a system of connected brain areas that show increased activity when a person is not focused on what is happening around them. Instead, the DMN is especially active when a person is engaged in introspective activities (e.g., daydreaming, or contemplating the past or future). Research suggests that the DMN is disrupted in people with Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD). Functional connectivity can be defined as the similarity between brain signals that arise from two anatomically separated brain regions. Similarity between the brain signals can be analyzed using Pearson's correlation. |
Change from baseline to 1-week post-treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Auditory Memory scores
Time Frame: Change from baseline to 1 week post-treatment.
|
The stories subtest of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used to assess auditory memory.
Raw scores will be transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants.
Thus the sample mean (across all arms) is zero for each test score.
The z-scores were then averaged to produce a composite scores.
Higher scores are indicative of better performance.
|
Change from baseline to 1 week post-treatment.
|
Change in Auditory Memory scores
Time Frame: Change from baseline to 6 months after treatment ends.
|
The stories subtest of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used to assess auditory memory.
Raw scores will be transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants.
Thus the sample mean (across all arms) is zero for each test score.
The z-scores were then averaged to produce a composite scores.
Higher scores are indicative of better performance.
|
Change from baseline to 6 months after treatment ends.
|
Change in Attention/Executive Function Cognitive Domain Scores
Time Frame: Change from baseline to 1-week post-treatment.
|
Neuropsychological tests will included the following domains: Attention/Executive Function (Trail Making Test A and B, Stroop Interference [Golden version]) Raw scores will be transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. Thus the sample mean (across all arms) is zero for each test score. The z-scores will be averaged to produce composite scores. Higher scores are indicative of better performance. |
Change from baseline to 1-week post-treatment.
|
Change in Attention/Executive Function Cognitive Domain Scores
Time Frame: Change from baseline to 6 months after treatment ends.
|
Neuropsychological tests will included the following domains: Attention/Executive Function (Trail Making Test A and B, Stroop Interference [Golden version]) Raw scores will be transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. Thus the sample mean (across all arms) is zero for each test score. The z-scores will be averaged to produce composite scores. Higher scores are indicative of better performance. |
Change from baseline to 6 months after treatment ends.
|
Change in Verbal Fluency scores
Time Frame: Change from baseline to 1-week post-treatment.
|
Controlled Oral Word Association test (FAS).
Raw scores will be transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants.
Thus the sample mean (across all arms) is zero for each test score.
Higher scores are indicative of better performance.
|
Change from baseline to 1-week post-treatment.
|
Change in Verbal Fluency scores
Time Frame: Change from baseline to 6 months after treatment ends.
|
Controlled Oral Word Association test (FAS).
Raw scores will be transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants.
Thus the sample mean (across all arms) is zero for each test score.
Higher scores are indicative of better performance.
|
Change from baseline to 6 months after treatment ends.
|
Change in Processing Speed Scores
Time Frame: Change from baseline to 1-week post-treatment.
|
Processing speed will be assessed with the coding subtest of RBANS as well as the Digit Symbol Substitution Test (DSST).
Raw scores will be transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants.
Thus the sample mean (across all arms) is zero for each test score.
The z-scores will be averaged to produce composite scores.
Higher scores are indicative of better performance.
|
Change from baseline to 1-week post-treatment.
|
Change in Processing Speed Scores
Time Frame: Change from baseline to 6 months after treatment ends.
|
Processing speed will be assessed with the coding subtest of RBANS as well as the Digit Symbol Substitution Test (DSST).
Raw scores will be transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants.
Thus the sample mean (across all arms) is zero for each test score.
The z-scores will be averaged to produce composite scores.
Higher scores are indicative of better performance.
|
Change from baseline to 6 months after treatment ends.
|
Change in Mobility
Time Frame: Change from baseline to 1-week post-treatment.
|
Mobility will be assessed with the Timed Up and Go (TUG) test, which assesses the time it takes participants to stand up from a chair, walk 3 meters, turn around, walk back to the chair and sit down.
In addition, we will assess steady-state gait during 90 seconds of continuous over-ground walking at normal preferred speed, with and without the addition of a dual task challenge (counting backward by one or by two).
|
Change from baseline to 1-week post-treatment.
|
Change in Mobility
Time Frame: Change from baseline to 6 months after treatment ends.
|
Mobility will be assessed with the Timed Up and Go (TUG) test, which assesses the time it takes participants to stand up from a chair, walk 3 meters, turn around, walk back to the chair and sit down.
In addition, we will assess steady-state gait during 90 seconds of continuous over-ground walking at normal preferred speed, with and without the addition of a dual task challenge (counting backward by one or by two).
|
Change from baseline to 6 months after treatment ends.
|
Change in Salience Network functional connectivity
Time Frame: Change from baseline to 1-week post-treatment.
|
The Salience Network consists of a network of brain regions whose cortical hubs are the anterior cingulate and ventral anterior insular (i.e., frontoinsular) cortices.
This network also includes nodes in the amygdala, hypothalamus, ventral striatum, thalamus, and specific brainstem nuclei.
|
Change from baseline to 1-week post-treatment.
|
Change in Language Network functional connectivity
Time Frame: Change from baseline to 1-week post-treatment.
|
The Language Network consists of a group of left-lateralized frontal and temporal brain regions that responds to written/spoken/signed words and sentences, but not to mental arithmetic, music perception, executive function tasks, or action/gesture perception.
|
Change from baseline to 1-week post-treatment.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PROMIS-29 Health-Related Quality of Life (HRQoL) Domains
Time Frame: Change from baseline to 1 week post-treatment.
|
The PROMIS-29 includes seven HRQoL domains: Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain).
The pain domain has two subdomains (interference and intensity).
Each of the 7 domains has four 5-level items (i.e., 16 decrements each).
In addition to these items, pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain (10), adding 10 additional decrements.
|
Change from baseline to 1 week post-treatment.
|
Change in PROMIS-29 Health-Related Quality of Life (HRQoL) Domains
Time Frame: Change from baseline to 6 months after treatment ends.
|
The PROMIS-29 includes seven HRQoL domains: Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain).
The pain domain has two subdomains (interference and intensity).
Each of the 7 domains has four 5-level items (i.e., 16 decrements each).
In addition to these items, pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain (10), adding 10 additional decrements.
|
Change from baseline to 6 months after treatment ends.
|
Change in measures of body awareness
Time Frame: Change from baseline to 1-week post-treatment.
|
We will examine 3 measures of body awareness: Interoceptive attention is the ability to sustain and control attention to body sensations.
Interoceptive self-regulation is the ability to regulate distress by attention to body sensations.
These two measures will be assessed with MAIA-2 self-report questionnaire.
We will also utilize the Body Awareness portion of the Body Experience Questionnaire to measure interoceptive attention/awareness.
|
Change from baseline to 1-week post-treatment.
|
Change in measures of body awareness
Time Frame: Change from baseline to 6 months after treatment ends.
|
We will examine 3 measures of body awareness: Interoceptive attention is the ability to sustain and control attention to body sensations.
Interoceptive self-regulation is the ability to regulate distress by attention to body sensations.
These two measures will be assessed with MAIA-2 self-report questionnaire.
We will also utilize the Body Awareness portion of the Body Experience Questionnaire to measure interoceptive attention/awareness.
|
Change from baseline to 6 months after treatment ends.
|
Change in a measure of mindfulness
Time Frame: Change from baseline to 1-week post-treatment.
|
Mindfulness will be assessed with the Freiburg Mindfulness Index (FMI), a valid and reliable 30-item questionnaire measuring mindfulness.
|
Change from baseline to 1-week post-treatment.
|
Change in a measure of mindfulness
Time Frame: Change from baseline to 6 months after treatment ends.
|
Mindfulness will be assessed with the Freiburg Mindfulness Index (FMI), a valid and reliable 30-item questionnaire measuring mindfulness.
|
Change from baseline to 6 months after treatment ends.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Linda L Chao, PhD, University of California, San Francisco & SFVAHCS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-33507
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Mild Cognitive Impairment
-
University of California, San FranciscoNational Institute on Aging (NIA)Active, not recruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Mackay Memorial HospitalBened Biomedical Co., Ltd.RecruitingMild Cognitive Impairment (MCI)Taiwan
-
Thomas Jefferson UniversityJohns Hopkins University; University of Pennsylvania; National Institute on Aging... and other collaboratorsCompletedMild Cognitive Impairment (MCI)United States
-
Palo Alto Veterans Institute for ResearchU.S. Army Medical Research and Development CommandCompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Assaf-Harofeh Medical CenterNeurim Pharmaceuticals Ltd.UnknownMild Cognitive Impairment (MCI)Israel
-
Centre for Addiction and Mental HealthRecruitingAmnestic Mild Cognitive ImpairmentCanada
-
University of FloridaNational Institute on Aging (NIA)RecruitingAmnestic Mild Cognitive ImpairmentUnited States
-
Charite University, Berlin, GermanyCompletedMild Cognitive Impairment (MCI)Germany
-
Johns Hopkins UniversityNational Institute on Aging (NIA)CompletedMild Cognitive Impairment (MCI)United States
Clinical Trials on Tai Chi
-
Harvard University Faculty of MedicineBeth Israel Deaconess Medical Center; Brigham and Women's HospitalCompleted
-
Lidian ChenPeking University Third HospitalNot yet recruiting
-
Chengdu University of Traditional Chinese MedicineNot yet recruitingQuality of Life | Dialysis; Complications | Chinese Medicine
-
Taipei Veterans General Hospital, TaiwanNational Science Council, TaiwanCompleted
-
University Hospital, Clermont-FerrandCompleted
-
Chang Gung Memorial HospitalCompleted
-
Texas Tech University Health Sciences CenterActive, not recruiting
-
Massachusetts General HospitalUnknown
-
Chen Li TienCompletedExercise TrainingTaiwan
-
Tufts Medical CenterMassachusetts General HospitalCompletedChronic Pain | FibromyalgiaUnited States