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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP - AZ160019 | Other Grant/Funding Number | Congressionally Directed Medical Research Programs Defense Health Agency Research & Development |
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| Name | Class |
|---|---|
| San Francisco VA Health Care System | FED |
| University of California, Los Angeles | OTHER |
| United States Department of Defense | FED |
| CDMRP |
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The purpose of this study is to compare the effects of three on-line wellness interventions for improving physical and cognitive function and brain connectivity in adults who are at least 55 years old and are experiencing symptoms of memory and/or cognitive difficulties.
The proposed study will perform a randomized, controlled trial (RCT) to compare the effects of three on-line wellness interventions for adults (age 55 years and older) who are experiencing memory and/or cognitive decline. Study participants will be randomly assigned to one of three on-line wellness interventions: (a) Tai Chi, (b) mindful movement course, or (c) health and wellness education course. All interventions will be one hour long, held on-line twice a week for 12 weeks. The co-primary outcomes are 3-month change in cognitive function (Alzheimer's Disease Assessment Scale - cognitive subscale, ADAS-cog) and functional brain connectivity within the default mode network (DMN). Secondary behavioral outcomes will include measures of specific cognitive processes (e.g., auditory memory, executive function, processing speed), physical function (e.g., mobility), anxiety, depression, fatigue, pain, sleep quality, social activities/social isolation, and quality of life. Secondary neuroimaging outcomes will include measures of functional connectivity in other intrinsic brain networks (e.g., salience, central executive, language), cerebral perfusion, and structural white matter integrity. The behavioral and imaging outcomes will be assessed at baseline and upon completion of the 12-week interventions. To assess durability of the behavioral effects of the interventions, the cognitive and behavioral outcomes will be assessed again 6 months after the completion of the interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tai Chi | Experimental | 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. |
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| Gentle, Mindful Movement | Experimental | 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. |
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| Health and Wellness Education | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tai Chi | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Scores | 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 | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Auditory Memory scores | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PROMIS-29 Health-Related Quality of Life (HRQoL) Domains | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda L Chao, PhD | University of California, San Francisco & SFVAHCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Health Care System | San Francisco | California | 94121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39809343 | Derived | Chao LL, Barnes DE, Chesney MA, Mehling WE, Lee JA, Benjamin C, Lavretsky H, Ercoli L, Siddarth P, Narr KL. Multi-domain Online Therapeutic Investigation Of Neurocognition (MOTION) - A randomized comparative-effectiveness study of two remotely delivered mind-body interventions for older adults with cognitive decline. Contemp Clin Trials. 2025 Feb;149:107811. doi: 10.1016/j.cct.2025.107811. Epub 2025 Jan 12. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D026302 | Tai Ji |
| D006262 | Health |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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| UNKNOWN |
Participants will be randomly assigned to an on-line Tai Chi class, an on-line mindful movement class, or to an on-line Health and Wellness Education classes. All classes will meet twice a week for one hour for 12-weeks. The randomization sequence will be generated in advance by Dr. Chao's research team using a random number generator and will be maintained in a secure location. Individuals who collect and analyze outcome data will be blinded to group assignment.
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The randomization sequence will be generated in advance by Dr. Chao's research team using a random number generator and will be maintained in a secure location. Individuals who collect or analyze outcome data will be blinded to group assignment.
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| Preventing Loss of Independence through Exercise (PLIE) | Behavioral | 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. |
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| Health and Wellness Education | Behavioral | This on-line class will consist of hour-long lectures/talks about various topics related to healthy aging and wellness. |
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| Change from baseline to 1 week post-treatment. |
| Change in Auditory Memory scores | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Change from baseline to 1 week post-treatment. |
| Change in PROMIS-29 Health-Related Quality of Life (HRQoL) Domains | 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 | 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 | 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 | 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 | 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. |
| D026741 |
| Physical Therapy Modalities |
| D011154 | Population Characteristics |