Mild Cognitive ImpairmentNCT04070703
Tai Ji Quan and Cognitive Function in Older Adults With Mild Cognitive Impairment
A study testing The Go for Exercise & Healthy Aging Project in people with Mild Cognitive Impairment, run by Oregon Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- The Go for Exercise & Healthy Aging Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- The Go for Exercise & Healthy Aging Project
- Keywords
- Cognitive function, mild cognitive impairment, Tai Ji Quan
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Go for Exercise & Healthy Aging ProjectBehavioural
Exercise and Cognition
| Study group | Role | What they receive |
|---|---|---|
| Cognitively enhanced Tai Ji Quan | Experimental | 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. Receives: Behavioral: The Go for Exercise & Healthy Aging Project |
| Standard Tai Ji Quan | Active comparator | 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. Receives: Behavioral: The Go for Exercise & Healthy Aging Project |
| Stretching | Sham comparator | 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. Receives: Behavioral: The Go for Exercise & Healthy Aging Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment
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.
Measured: baseline, 6 months
Gait Performance Under a Dual-task Condition
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.
Measured: baseline, 6 months
Secondary outcomes (8)
Clinical Dementia Rating Scale
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).
Measured: baseline, 6 months
Domain-specific Cognitive Test - Trail Making - B
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.
Measured: baseline, 6 months
4-Stage Balance Test
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.
Measured: baseline, 6 months
Backward Digit Span
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.
Measured: baseline, 6 months
Verbal Fluency Test
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).
Measured: baseline, 6 months
Timed up and go
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.
Measured: baseline, 6 months
30-Second Chair Stands Test
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).
Measured: baseline, 6 months
Forward Digit Span Test
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.
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Oct 2019
- Primary completion30 Nov 2023
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fuzhong Li, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070703
- Sponsor's protocol ID
- AG059546
- Status last verified
- Jul 2026
- First submitted
- 26 Aug 2019
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37903365Li 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.
PubMed 39688866Li 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.
PubMed 35078407
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adapted Tai Ji Quan to Slow Cognitive Decline in Older Adults
- ClinicalTrials.gov ID
- NCT04070703
- Acronym / sponsor ID
- AG059546
- Conditions
- Mild Cognitive Impairment
- Keywords
- Cognitive function, mild cognitive impairment, Tai Ji Quan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitively enhanced Tai Ji Quan | Experimental | Behavioral: The Go for Exercise & Healthy Aging ProjectParticipants 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. |
| Standard Tai Ji Quan | Active comparator | Behavioral: The Go for Exercise & Healthy Aging ProjectServing 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. |
| Stretching | Sham comparator | Behavioral: The Go for Exercise & Healthy Aging ProjectServing as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Go for Exercise & Healthy Aging ProjectExercise and Cognition | Behavioural | Cognitively enhanced Tai Ji Quan, Standard Tai Ji Quan, Stretching |
Primary outcome
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.
Gait Performance Under a Dual-task Condition
Time frame: baseline, 6 months
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.
8 secondary outcomes
Clinical Dementia Rating Scale
Time frame: baseline, 6 months
Domain-specific Cognitive Test - Trail Making - B
Time frame: baseline, 6 months
4-Stage Balance Test
Time frame: baseline, 6 months
Backward Digit Span
Time frame: baseline, 6 months
Verbal Fluency Test
Time frame: baseline, 6 months
Timed up and go
Time frame: baseline, 6 months
30-Second Chair Stands Test
Time frame: baseline, 6 months
Forward Digit Span Test
Time frame: baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37903365Li 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.
- Derived from this study: PubMed 39688866Li 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.
- Derived from this study: PubMed 35078407Li 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.
- published articleLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuzhong Li, Ph.D. principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Go for Exercise & Healthy Aging Project in people with Mild Cognitive Impairment, run by Oregon Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (time frame: baseline, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04070703, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.