Multi-domain Online Therapeutic Investigation Of Neurocognition (MOTION)

University of California San Francisco (UCSF)

Status: Active, not recruiting

Conditions: Subjective Memory Decline; Mild Cognitive Impairment

Treatments: Behavioral: Tai Chi; Behavioral: Preventing Loss of Independence through Exercise (PLIE); Behavioral: Health and Wellness Education

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05217849

21-33507

CDMRP - AZ160019 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 3 patient groups

Tai Chi

Experimental group

Description:

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.

Treatment:

Behavioral: Tai Chi

Gentle, Mindful Movement

Experimental group

Description:

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.

Treatment:

Behavioral: Preventing Loss of Independence through Exercise (PLIE)

Health and Wellness Education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health and Wellness Education