- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070703
Tai Ji Quan and Cognitive Function in Older Adults With Mild Cognitive Impairment
August 22, 2025 updated by: Oregon Research Institute
Efficacy of Adapted Tai Ji Quan to Slow Cognitive Decline in Older Adults
To determine the efficacy of a cognitively enhanced exercise intervention - Tai Ji Quan: Moving to Maintain Brain Health in improving global cognitive function and dual-task ability in older adults with mild cognitive impairment.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The primary aim of the study is to determine the efficacy of a cognitively enhanced exercise intervention - Tai Ji Quan: Moving to Maintain Brain Health, relative to a standard Tai Ji Quan intervention and an exercise stretching control, in improving global cognitive function and dual-task ability among community-dwelling older adults with amnestic mild cognitive impairment.
Study Type
Interventional
Enrollment (Actual)
318
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Oregon
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Eugene, Oregon, United States, 97403
- Oregon Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 95 years (Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- complaint of memory loss
- clinical dementia rating (CDR) scale score ≤0.5
- having normal general cognitive function screened, with MMSE ≥24
- capable of exercising safely, as determined by a healthcare provider
- willingness to be randomly assigned to an intervention condition and complete the 24-week intervention and 6-month follow-up
Exclusion Criteria:
- having medical conditions likely to compromise survival, such as metastatic cancer, or render a participant unable to engage in physical activity, such as severe cardiac failure
- participating in any type of Tai Ji Quan or daily and/or structured vigorous physical activity (i.e., brisk walking for exercise 30 minutes or longer at a time, or engaging in muscle-strengthening activities, e.g., weight lifting on 3 or more days per week 3 months prior to the study)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitively enhanced Tai Ji Quan
Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.
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Exercise and Cognition
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Active Comparator: Standard Tai Ji Quan
Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.
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Exercise and Cognition
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Sham Comparator: Stretching
Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.
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Exercise and Cognition
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montreal Cognitive Assessment
Time Frame: baseline, 6 months
|
The Montreal Cognitive Assessment scale measures change in global cognitive function from baseline to 6 months.
The scale scores range from 0 to 30 points, with higher scores indicating better cognitive functioning.
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baseline, 6 months
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Gait Performance Under a Dual-task Condition
Time Frame: baseline, 6 months
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Assessing change in dual-task ability (measured in seconds) from baseline to 6 months.
Change will be assessed via an Instrumental Timed Up&Go (iTUG) gait performance (APDM, Inc.) in which the participant is asked to stand up from a chair, walk a 6-m walkway at normal pace (3 m toward a line, turn, and 3 m toward the chair), turn around, and sit down on the chair, with no cognitive task (single-task walking).
The participant is then asked to perform the same procedure with a concurrent cognitive task (counting backward by 3s, starting with an odd number, e.g., 81).12
The total walking duration (in seconds) during both 6-meter walks, at normal pace, will be recorded.
Lower duration indicates a better outcome.
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baseline, 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Dementia Rating Scale
Time Frame: baseline, 6 months
|
The Clinical Dementia Rating Scale measures change in cognitive decline from baseline to 6 months.
The scale measures six domains of cognitive and functional performance.
Scores range from 0 to 3 points in each domain, with a score of 0 indicating no impairment, while a score of 3 signifying severe impairment.
Scores from all domains have been averaged to compute the total score reported.
In this trial, lower scores indicate less severity in cognitive decline (i.e., improvement from intervention).
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baseline, 6 months
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Domain-specific Cognitive Test - Trail Making - B
Time Frame: baseline, 6 months
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Change in domain-specific cognitive function - executive function (measured in seconds) from baseline to 24 weeks.
Trail Making Test assesses attention and executive function.
In this test, the participant connects numbers and letters in an alternating progressive sequence, 1 to A, 2 to B, 3 to C, and so on.
For parts A and B, scoring is expressed in terms of the time (in seconds) to completion.
Lower scores indicate higher executive functioning.
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baseline, 6 months
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4-Stage Balance Test
Time Frame: baseline, 6 months
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The 4-Stage Balance Test measures change, from baseline to 6 months, in standing four positions balance.
Participants attempt to hold four progressively challenging standing positions.
The test ends if a position cannot be held for 10 seconds.
The number of positions successfully completed is recorded and awarded one point (0-4), with higher score values indicating better balance.
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baseline, 6 months
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Backward Digit Span
Time Frame: baseline, 6 months
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The Backward Digit Span test assesses memory.
The participant is verbally presented with a series of digits (e.g., 6, 2, 9, 7) at a rate of one digit per second and is required to repeat them verbatim.
If the participant succeeds, he/she is given a longer list (e.g., 5, 3, 8, 1, 6).
The number of digits increases by one until the participant consecutively fails two trials of the same digit span length.
The length of the longest list a person can remember is that person's digit span.
In this test, the participant is required to repeat the digits in reverse.
The participant receives 1 point for each correct answer.
The Backward Digit Span test scores range from 0 to 32, with higher scores indicating better memory.
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baseline, 6 months
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Verbal Fluency Test
Time Frame: baseline, 6 months
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The Verbal Fluency Test assesses verbal fluency and executive function of cognitive function.
The participant is asked to generate the names of as many animals as possible in 60 seconds.
High scores (i.e., more animals names generated) in this measure indicate better performance (i.e., better verbal fluency and executive function).
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baseline, 6 months
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Timed up and go
Time Frame: baseline, 6 months
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The Timed up and go (TUG) measure is recorded in seconds (the time taken by an individual to stand up from a standard armless chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down).
Lower scores indicate better performance.
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baseline, 6 months
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30-Second Chair Stands Test
Time Frame: baseline, 6 months
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The 30-Second Chair Stands Test is used to measure change from baseline to 6 months in physical performance.
The Test involves repeatedly standing up from and sitting down in a chair as many times as possible within 30 seconds, with high (count) scores indicating better performance (i.e., leg strength).
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baseline, 6 months
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Forward Digit Span Test
Time Frame: baseline, 6 months
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The Forward Digit Span test measures attention/concentration (in points) with high scores indicating better attention.
The participant is verbally presented with a series of digits (e.g., 6, 2, 9, 7) at a rate of one digit per second and is required to repeat them verbatim.
If the participant succeeds, he/she is given a longer list (e.g., 5, 3, 8, 1, 6).
The number of digits increases by one until the participant consecutively fails two trials of the same digit span length.
The length of the longest list a person can remember is that person's digit span.
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baseline, 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)
Time Frame: baseline, 6 months
|
Change in sleep quality from baseline to 24 weeks.
The Pittsburgh Sleep Quality Index (PSQI) includes seven indices: subjective quality, latency (i.e., time needed to fall asleep), duration (i.e., number of hours of actual sleep per night), efficiency (i.e., total sleep time divided by time in bed, converted to a score of 0-3), sleep disturbances (e.g., waking up in the middle of the night and the like), use of sleeping medication, and daytime dysfunction (e.g., having difficulty staying awake during the day).
Each of the component scores ranges from 0 to 3, with the PSQI global score ranging from 0 to 21 points, with higher scores indicating poorer sleep quality.
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baseline, 6 months
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Depression - Geriatric Depression Scale (GDS)
Time Frame: baseline, 6 months
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Change in depression from baseline to 24 weeks.
The Geriatric Depression Scale (GDS) score ranges from 0 to 15 with higher scores indicated increased depression symptoms and scores higher than 5 indicative of depression.
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baseline, 6 months
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Activity and Movement Confidence Scales
Time Frame: baseline, 6 months
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The Activity and Movement Confidence Scales measure a person's movement confidence.
In this study it assesses change in activity and movement confidence from baseline to 24 weeks.
The total score ranges from 0 to 100 with higher scores indicating higher confidence.
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baseline, 6 months
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Quality of Life - EuroQol.
Time Frame: baseline, 6 months
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The Quality of Life - EuroQol.
scale assesses quality of life.
Change in quality of life from baseline to 24 weeks.
The EQ-5D-3L version will be used that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
The scores of EQ-5D-3L will be averaged to generate a single utility value ranging from 1.00 for the "best health" state to -0.594 for the "worst health" state, where a score of 0 is indicative of death, and scores less than 0 are considered as "worse than death."
Participants who die during the trial period will be registered as 0 in utility terms for the assessment period from when the death occurred.
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baseline, 6 months
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International Physical Activity Questionnaire (IPAQ)
Time Frame: baseline and 6 months
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The International Physical Activity Questionnaire (IPAQ) measures the level of moderate and vigorous physical activity (MVPA) (measured in minutes) with high scores indicating high level of physical activity.
This measure asks participants to report how often (measured in days) and how much time (in minutes) over the previous week they participated in physical activity or exercise of any moderate (ex.
gardening, cleaning, etc.) or vigorous (ex.
heavy lifting, jogging/running or fast bicycling, etc.) intensity that lasted at least 10 minutes at a time.
The activities to be asked during the post-intervention follow-up (at 6 months) will not include the time spent in attending the assigned exercise programs in the study.
Total weekly duration of MVPA, measured in minutes, are calculated by multiplying frequency and duration (vigorous activity weighted by 2) to form a total weighted amount of MVPA min/week.
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baseline and 6 months
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Everyday Cognition Scale
Time Frame: baseline, 6 months
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The Everyday Cognition Scale measures change from baseline to 6 months in everyday cognitive function.
Sub scale scores will be averaged to create a total score.
Total scores range 1 to 4, with higher scores indicating better everyday cognitive function.
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baseline, 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fuzhong Li, Ph.D., Oregon Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Li F, Harmer P, Fitzgerald K, Winters-Stone K. A cognitively enhanced online Tai Ji Quan training intervention for community-dwelling older adults with mild cognitive impairment: A feasibility trial. BMC Geriatr. 2022 Jan 25;22(1):76. doi: 10.1186/s12877-021-02747-0.
- Li F, Harmer P, Eckstrom E, Fitzgerald K, Winters-Stone K. Clinical Effectiveness of Cognitively Enhanced Tai Ji Quan Training on Global Cognition and Dual-Task Performance During Walking in Older Adults With Mild Cognitive Impairment or Self-Reported Memory Concerns : A Randomized Controlled Trial. Ann Intern Med. 2023 Nov;176(11):1498-1507. doi: 10.7326/M23-1603. Epub 2023 Oct 31.
- Li F, Harmer P, Eckstrom E, Winters-Stone K. Physical Activity Engagement After Tai Ji Quan Intervention Among Older Adults With Mild Cognitive Impairment or Memory Concerns: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2450457. doi: 10.1001/jamanetworkopen.2024.50457.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2019
Primary Completion (Actual)
November 30, 2023
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
August 26, 2019
First Submitted That Met QC Criteria
August 26, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Estimated)
August 26, 2025
Last Update Submitted That Met QC Criteria
August 22, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AG059546
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The individual level data in this study will not be shared with others for reasons of confidentiality.
However, a dataset with identifiable private information removed may be made available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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