NCT05217849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

November 16, 2021

Last Update Submit

February 5, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

Secondary Outcomes (12)

  • Change in Auditory Memory scores

    Change from baseline to 1 week post-treatment.

  • Change in Auditory Memory scores

    Change from baseline to 6 months after treatment ends.

  • Change in Attention/Executive Function Cognitive Domain Scores

    Change from baseline to 1-week post-treatment.

  • Change in Attention/Executive Function Cognitive Domain Scores

    Change from baseline to 6 months after treatment ends.

  • Change in Verbal Fluency scores

    Change from baseline to 1-week post-treatment.

  • +7 more secondary outcomes

Other Outcomes (6)

  • Change in PROMIS-29 Health-Related Quality of Life (HRQoL) Domains

    Change from baseline to 1 week post-treatment.

  • Change in PROMIS-29 Health-Related Quality of Life (HRQoL) Domains

    Change from baseline to 6 months after treatment ends.

  • Change in measures of body awareness

    Change from baseline to 1-week post-treatment.

  • +3 more other outcomes

Study Arms (3)

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.

Behavioral: Tai Chi

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.

Behavioral: Preventing Loss of Independence through Exercise (PLIE)

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.

Behavioral: Health and Wellness Education

Interventions

This on-line class will consist of hour-long lectures/talks about various topics related to healthy aging and wellness.

Health and Wellness Education
Tai ChiBEHAVIORAL

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.

Also known as: Tai-Chi-Chih (TCC)
Tai Chi

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.

Also known as: gentle, mindful movement class
Gentle, Mindful Movement

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Health Care System

San Francisco, California, 94121, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Tai JiHealth

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesPopulation Characteristics

Study Officials

  • Linda L Chao, PhD

    University of California, San Francisco & SFVAHCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

February 1, 2022

Study Start

February 15, 2022

Primary Completion

July 16, 2024

Study Completion

December 31, 2025

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations