Mild Cognitive ImpairmentNCT05725668
A Study of Dual-task Exercise Training to Prevent Falls Among Older Adults With Mild Cognitive Impairment
A study testing dual-task tai ji quan, standard tai ji quan and stretching in people with Mild Cognitive Impairment and Accidental Falls, run by Oregon Research Institute at 1 site in United States.
Trial summary
To determine the efficacy of a dual-task tai ji quan training therapy in reducing the incidence of falls 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, Accidental Falls, Aging
- What is being tested?
- dual-task tai ji quan, standard tai ji quan and stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2023to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- being 65 years and older
- having complaint of memory loss
- scoring ≤0.5 on Clinical Dementia Scale
- having had 1 or more falls in the preceding 12 months or scoring ≥12 seconds on the Timed Up and Go test
Who cannot join
- scoring <24 on the Mini-Mental State Examination
- being able to ambulate independently for household distances
- having medical clearance
- having participated in any regular and structured tai ji quan-based exercise programs (≥2 times weekly) in the preceding 6 months
- having a progressive neuromuscular disorder such as Parkinson's disease or multiple sclerosis
- being unwilling to be randomized
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Research Institute
Springfield, Oregon, 97477
Fuzhong Li, Ph.D., 541-484-2123 ext. 2137, fuzhongl@ori.org
Fuzhong Li, Ph.D.
About this study
Official title: Dual-Task Training Exercise to Reduce Falls in Older Adults With Mild Cognitive Impairment
To determine the efficacy of a dual-task tai ji quan training therapy in reducing the incidence of falls in older adults with mild cognitive impairment.
Read the detailed description
The primary aim of the study is to determine the comparative efficacy of two tai ji quan interventions (Dual-task tai ji quan, standard tai ji quan), relative to a stretching exercise control, in reducing the incidence of falls among community-dwelling older adults with mild cognitive impairment.
- Conditions
- Mild Cognitive Impairment, Accidental Falls, Aging
- Being tested
- dual-task tai ji quan, standard tai ji quan, stretching
- Keywords
- Falls, Exercise, Dual tasking
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual-task tai ji quanBehavioural
dual-task tai ji quan training
standard tai ji quanBehavioural
standard tai ji quan training
stretchingBehavioural
stretching exercise
| Study group | Role | What they receive |
|---|---|---|
| Dual-task taj ji quan | Experimental | This intervention includes training of (a) symmetrical postural tai ji quan forms/movements synchronized with breathing, (b) controlled displacement (weight-shifting) of the body's center of mass over the base of support, (c) dynamic eye-hand movements during whole-body motion, (d) multidirectional (anterior-posterior and medial-lateral) stepping, and (e) rotational ankle sway and self-induced reactive postural recovery actions. The training practices are integrated, gradually over time, with a mix of interactive, cognitively stimulating, dual-task exercises that challenge attention control, working memory, verbalization, response inhibition, processing speed, dual tasking, task switching/prioritization, and spatial orientation and postural awareness. Receives: Behavioral: dual-task tai ji quan |
| Standard tai ji quan | Experimental | This intervention includes training of tai ji quan forms with synchronized breathing, supplemented by a set of mini-therapeutic exercises. The training involves repeated practice of (a) symmetrical, coordinated, trunk-driven tai ji quan form movements, (b) controlled displacement (weight-shifting) of the body's center of mass over varying sizes of the base of support, (c) dynamic eye-hand movements during whole-body motion, and (d) multidirectional (anterior-posterior and medial-lateral) stepping. As a balance training therapy, movement practices emphasize a dynamic interplay of stabilizing and self-induced destabilizing postural actions and balance exercises that target mobility, stability limits, and sensory integration. Receives: Behavioral: standard tai ji quan |
| Stretching exercise | Experimental | This active control intervention includes light activities that consist of breathing, stretching, and relaxation exercises. Each exercise session encompasses a variety of light and static stretches for joints and muscles, performed in a seated or standing position. Exercise involves the upper body (arms, neck, upper back, shoulder, back, and chest), lower extremities (quadriceps, hamstrings/calfs, and hips), and gentle and slow trunk rotations. Also included are intermittent light walking, deep abdominal breathing exercises that emphasize inhaling and exhaling to maximum capacity, and progressive relaxation of major muscle groups. Receives: Behavioral: stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported number of falls
This measure will reflect change in the incidence of falls as a result of intervention. Study participants will be given a falls calendar to record number of falls at home. Falls are defined as "when you land on the floor or the ground, or fall and hit objects like stairs or pieces of furniture, by accident." This information will be ascertained monthly via a phone call by study assessors
Measured: Monthly, baseline to 6 months (i.e., after end of intervention)
Secondary outcomes (10)
Short Physical Performance Battery
Reflects change in lower extremity function with intervention. This is measured by Short Physical Performance Battery which involves three functional tasks: static balance, gait speed, and getting in and out of a chair, with scores ranging from 0 (worst performance) to 12 (best performance).
Measured: Baseline, 4 months, 6 months, 12 months
Timed Up and Go (TUG)
Reflects change in lower extremity physical function with intervention. This is measured by the Timed Up and Go test (TUG; in seconds) which assesses mobility and fall risk. The test measures the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Lower scores represent better lower extremity physical function.
Measured: Baseline, 4 months, 6 months, 12 months
Dual-task walking
Reflects change in dual-task costs in gait speed with intervention. The TUG test protocol will be repeated under a dual-task condition where the participant is asked to walk while performing an arithmetic task (i.e., starting at the number 81 and sequentially subtracting 5 from the resulting number). Lower scores on this walk indicate better performance. Dual-task walking cost is defined as the difference between single- and dual-task walking speed, expressed in percentage, with less negative values representing improvement in dual-task walking speed relative to single-task walking.
Measured: Baseline, 4 months, 6 months, 12 months
30-second chair stand
Reflects change in lower extremity strength and endurance with intervention. This is measured by the 30-second chair stand test. The test is conducted by asking the participant to stand up from a chair and sit down fully and to perform as many cycles of sit-to-stand-to-sit as possible in 30 seconds. Higher scores (number of stands) represent higher levels of strength and endurance.
Measured: Baseline, 4 months, 6 months, 12 months
Montreal Cognitive Assessment (MoCA)
Reflects change in global cognitive function. This is measured by MoCA which measures cognitive function of multiple domains (attention/concentration, executive functions, short term memory, language, visuospatial abilities, orientation to time and place). MoCA has a total score that ranges from 0 to 30, with higher scores representing better cognitive functioning.
Measured: Baseline, 4 months, 6 months, 12 months
Trail Making (A, B)
Reflects change in executive function with intervention. This is measured by Trail Making Test (TMT) which consists of two parts (A and B). In Part A, the participant is asked to count the number (1 through 25) off the screen out loud as quickly as possible. In Part B, the participant is asked to recite numbers and letters in an alternating sequence (1-A-2-B-3-C . . . 12-L) as quickly as possible. Errors are corrected immediate with the clock running. For Parts A and B, scoring is expressed in terms of the time (in seconds) to completion. The difference in time taken to complete Part B versus Part A is calculated to form a measure of executive function, with smaller difference scores indicating better executive function.
Measured: Baseline, 4 months, 6 months, 12 months
Category Fluency
Reflects change in memory with intervention. This is measured by a category fluency test in which the participant is asked to generate the names of as many animals as possible in 60 seconds.
Measured: Baseline, 4 months, 6 months, 12 months
Forward Digit Span
Reflects change in attention with intervention. This is measured by Forward Digit Span test. During the test, the participant is asked to repeat a series of digits in the order given. The maximum raw score is 16, with higher scores indicating better attention.
Measured: Baseline, 4 months, 6 months, 12 months
Backward Digit Span
Reflects change in short-term working memory with intervention. This is measured by Backward Digit Span test. During the test, the participant is asked to repeat a series of digits in reverse order. The maximum raw score is 16, with higher scores indicating better memory.
Measured: Baseline, 4 months, 6 months, 12 months
Proportion of fallers
Number of fallers from participants at 6 months in each intervention group
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start15 Jul 2023
- Primary completion30 Jul 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725668
- Sponsor's protocol ID
- AG074045-01A1
- Status last verified
- Dec 2025
- First submitted
- 2 Feb 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following data will be made available with publication: deidentified participant data and data directory. Additional data that have not been published will be withheld until at least 6 months after publication. Data will be made available as required for specific, approved analyses and will be provided from a locked, cleaned, and deidentified database. Requests will be reviewed the principal investigator before approval. Before any analysis, a signed confidentiality agreement or data sharing agreement is required.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Task Training Exercise to Reduce Falls in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05725668
- Acronym / sponsor ID
- AG074045-01A1
- Conditions
- Mild Cognitive Impairment, Accidental Falls, Aging
- Keywords
- Falls, Exercise, Dual tasking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
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 dual-task tai ji quan training therapy in reducing the incidence of falls in older adults with mild cognitive impairment.
Detailed description
The primary aim of the study is to determine the comparative efficacy of two tai ji quan interventions (Dual-task tai ji quan, standard tai ji quan), relative to a stretching exercise control, in reducing the incidence of falls among community-dwelling older adults with 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 |
|---|---|---|
| Dual-task taj ji quan | Experimental | Behavioral: dual-task tai ji quanThis intervention includes training of (a) symmetrical postural tai ji quan forms/movements synchronized with breathing, (b) controlled displacement (weight-shifting) of the body's center of mass over the base of support, (c) dynamic eye-hand movements during whole-body motion, (d) multidirectional (anterior-posterior and medial-lateral) stepping, and (e) rotational ankle sway and self-induced reactive postural recovery actions. The training practices are integrated, gradually over time, with a mix of interactive, cognitively stimulating, dual-task exercises that challenge attention control, working memory, verbalization, response inhibition, processing speed, dual tasking, task switching/prioritization, and spatial orientation and postural awareness. |
| Standard tai ji quan | Experimental | Behavioral: standard tai ji quanThis intervention includes training of tai ji quan forms with synchronized breathing, supplemented by a set of mini-therapeutic exercises. The training involves repeated practice of (a) symmetrical, coordinated, trunk-driven tai ji quan form movements, (b) controlled displacement (weight-shifting) of the body's center of mass over varying sizes of the base of support, (c) dynamic eye-hand movements during whole-body motion, and (d) multidirectional (anterior-posterior and medial-lateral) stepping. As a balance training therapy, movement practices emphasize a dynamic interplay of stabilizing and self-induced destabilizing postural actions and balance exercises that target mobility, stability limits, and sensory integration. |
| Stretching exercise | Experimental | Behavioral: stretchingThis active control intervention includes light activities that consist of breathing, stretching, and relaxation exercises. Each exercise session encompasses a variety of light and static stretches for joints and muscles, performed in a seated or standing position. Exercise involves the upper body (arms, neck, upper back, shoulder, back, and chest), lower extremities (quadriceps, hamstrings/calfs, and hips), and gentle and slow trunk rotations. Also included are intermittent light walking, deep abdominal breathing exercises that emphasize inhaling and exhaling to maximum capacity, and progressive relaxation of major muscle groups. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- being 65 years and older
- having complaint of memory loss
- scoring ≤0.5 on Clinical Dementia Scale
- having had 1 or more falls in the preceding 12 months or scoring ≥12 seconds on the Timed Up and Go test
Key exclusion criteria (6 listed)
- scoring <24 on the Mini-Mental State Examination
- being able to ambulate independently for household distances
- having medical clearance
- having participated in any regular and structured tai ji quan-based exercise programs (≥2 times weekly) in the preceding 6 months
- having a progressive neuromuscular disorder such as Parkinson's disease or multiple sclerosis
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 |
|---|---|---|
| dual-task tai ji quandual-task tai ji quan training | Behavioural | Dual-task taj ji quan |
| standard tai ji quanstandard tai ji quan training | Behavioural | Standard tai ji quan |
| stretchingstretching exercise | Behavioural | Stretching exercise |
Primary outcome
Self-reported number of falls
Time frame: Monthly, baseline to 6 months (i.e., after end of intervention)
This measure will reflect change in the incidence of falls as a result of intervention. Study participants will be given a falls calendar to record number of falls at home. Falls are defined as "when you land on the floor or the ground, or fall and hit objects like stairs or pieces of furniture, by accident." This information will be ascertained monthly via a phone call by study assessors
10 secondary outcomes
Short Physical Performance Battery
Time frame: Baseline, 4 months, 6 months, 12 months
Timed Up and Go (TUG)
Time frame: Baseline, 4 months, 6 months, 12 months
Dual-task walking
Time frame: Baseline, 4 months, 6 months, 12 months
30-second chair stand
Time frame: Baseline, 4 months, 6 months, 12 months
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, 4 months, 6 months, 12 months
Trail Making (A, B)
Time frame: Baseline, 4 months, 6 months, 12 months
Category Fluency
Time frame: Baseline, 4 months, 6 months, 12 months
Forward Digit Span
Time frame: Baseline, 4 months, 6 months, 12 months
Backward Digit Span
Time frame: Baseline, 4 months, 6 months, 12 months
Proportion of fallers
Time frame: At 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Yes. The following data will be made available with publication: deidentified participant data and data directory. Additional data that have not been published will be withheld until at least 6 months after publication. Data will be made available as required for specific, approved analyses and will be provided from a locked, cleaned, and deidentified database. Requests will be reviewed the principal investigator before approval. Before any analysis, a signed confidentiality agreement or data sharing agreement is required.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual-task tai ji quan, standard tai ji quan and stretching in people with Mild Cognitive Impairment and Accidental Falls, 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fuzhong Li, Ph.D. (541-484-2123, fuzhongl@ori.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported number of falls (time frame: Monthly, baseline to 6 months (i.e., after end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2025.