Clinical trial NCT05217849: Multi-domain Online Therapeutic Investigation Of Neurocognition (MOTION)
Official title: Multi-domain Online Therapeutic Investigation Of Neurocognition
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Subjective Memory Decline
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco VA Health Care System
name: University of California, Los Angeles
name: United States Department of Defense
First posted: 2022-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Scores
timeFrame: Change from baseline to 1-week post-treatment.
measure: Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Scores
timeFrame: Change from baseline to 6 months after treatment ends.
measure: Change in Default Mode Network (DMN) functional connectivity
timeFrame: Change from baseline to 1-week post-treatment.
Secondary outcomes:
measure: Change in Auditory Memory scores
timeFrame: Change from baseline to 1 week post-treatment.
measure: Change in Auditory Memory scores
timeFrame: Change from baseline to 6 months after treatment ends.
measure: Change in Attention/Executive Function Cognitive Domain Scores
timeFrame: Change from baseline to 1-week post-treatment.
measure: Change in Attention/Executive Function Cognitive Domain Scores
timeFrame: Change from baseline to 6 months after treatment ends.
measure: Change in Verbal Fluency scores
timeFrame: Change from baseline to 1-week post-treatment.
measure: Change in Verbal Fluency scores
timeFrame: Change from baseline to 6 months after treatment ends.
measure: Change in Processing Speed Scores
timeFrame: Change from baseline to 1-week post-treatment.
measure: Change in Processing Speed Scores
timeFrame: Change from baseline to 6 months after treatment ends.
measure: Change in Mobility
timeFrame: Change from baseline to 1-week post-treatment.
measure: Change in Mobility
timeFrame: Change from baseline to 6 months after treatment ends.
measure: Change in Salience Network functional connectivity
timeFrame: Change from baseline to 1-week post-treatment.
measure: Change in Language Network functional connectivity
timeFrame: Change from baseline to 1-week post-treatment.
Other outcomes:
measure: Change in PROMIS-29 Health-Related Quality of Life (HRQoL) Domains
timeFrame: Change from baseline to 1 week post-treatment.
measure: Change in PROMIS-29 Health-Related Quality of Life (HRQoL) Domains
timeFrame: Change from baseline to 6 months after treatment ends.
measure: Change in measures of body awareness
timeFrame: Change from baseline to 1-week post-treatment.
measure: Change in measures of body awareness
timeFrame: Change from baseline to 6 months after treatment ends.
measure: Change in a measure of mindfulness
timeFrame: Change from baseline to 1-week post-treatment.
measure: Change in a measure of mindfulness
timeFrame: Change from baseline to 6 months after treatment ends.
Locations:
city: San Francisco
country: United States
facility: VA Health Care System
state: California
Study officials:
affiliation: University of California, San Francisco & SFVAHCS
name: Linda L Chao, PhD
role: PRINCIPAL_INVESTIGATOR
References: