- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05822466
Virtual Tai ji Quan Exercise to Prevent Falls in Older Adults
January 30, 2026 updated by: Oregon Research Institute
A Remotely Delivered Tai Ji Quan Intervention to Reduce Incidence of Falls in High Risk Community-Dwelling Older Adults
To examine two different exercise programs in reducing incidence of falls among community-dwelling older adults
Study Overview
Status
Recruiting
Conditions
Detailed Description
This is a randomized controlled trial aimed at determining the effectiveness of a virtual and home-based tai ji quan intervention vs. a virtual and home-based multimodal exercise intervention in reducing incidence of falls among community-dwelling older adults at high risk of falling
Study Type
Interventional
Enrollment (Estimated)
620
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 Contact
- Name: Fuzhong Li, Ph.D.
- Phone Number: 541-484-2123
- Email: fuzhongl@ori.org
Study Locations
-
-
Oregon
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Springfield, Oregon, United States, 97477
- Recruiting
- Oregon Research Institute
-
Contact:
- Fuzhong Li, Ph.D.
- Phone Number: 2137 541-484-2123
- Email: fuzhongl@ori.org
-
Principal Investigator:
- Fuzhong Li, Ph.D.
-
-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- age between 65 and 90 years and
- having had 1 or more falls in the preceding 12 months or having a score ≥12 seconds on the Timed Up&Go (TUG) test.
Exclusion Criteria:
- showing a diagnosis of dementia or significant cognitive impairment, as indicated by a score of <24 on the Mini Mental State Evaluation (MMSE, range: 0-30);
- being unable to ambulate independently for household distances; (c) having no medical clearance;
- having participated in any regular and structured tai ji quan-based or multicomponent exercise programs (≥2 times weekly) in the preceding 6 months;
- having any physical condition that would preclude participation in moderate-intensity exercise; and
- being unwilling to commit to the duration of the intervention or accept group assignment.
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 |
|---|---|
|
Active Comparator: Virtual tai ji quan
Participants participating are intervened with practice and drills of tai ji quan forms and associated movements.
Training focuses on lower-extremity strength, postural control, and mobility, with an emphasis on weight bearing and weight shifting, extending and controlling the body's center of mass over its base of support; self-induced movement perturbation; gait preparation, initiation, locomotion, and termination; and sensory integration.
The exercise training also emphasizes connecting tai ji quan forms to transitional movements that are associated with performing daily activities.
Each session includes brief movement-based warm-ups and light breathing cool-down exercises.
|
This intervention involves a tai ji quan exercise program, named tai ji quan: moving for better balance
Other Names:
|
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Active Comparator: Virtual multimodal exercise
Participants participating are intervened with a multicomponent exercise program that involves light walking, strength, postural control, and flexibility exercises.
Walking exercises include amble forward and backward walk, long strides, heel-toe walking, narrow- and wide-base walking, and sidestepping.
Strength training includes single- and multi-joint exercises such as semi-squats, lunging forward and sideways, and toe stands that involve exercising ankle dorsiflexors, knee extensors, and hip abductors.
Balance training involves semi-tandem foot-standing, heel-toe and line walking, single-leg standing, alternation of the base of support, weight transfers, toe and heel movements, and various reaching and stretching movements away from the center of the base of support.
Flexibility exercises include a static stretching routine of major upper and lower body muscle groups.
Each session includes brief movement-based warm-ups and light breathing cool-down exercises.
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This intervention involves a multimodal exercise program that consists of balance, strength, light walking, and stretching exercises
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported number of falls
Time Frame: Monthly, baseline to 6 months
|
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
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Monthly, baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Time Frame: Baseline, 4 months, 6 months, and 12 months
|
This measure reflects change in lower extremity function with intervention.
This is measured by SPPB 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).
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Baseline, 4 months, 6 months, and 12 months
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Timed up and Go (TUG)
Time Frame: Baseline, 4 months, 6 months, and 12 months
|
Reflects change in mobility performance with intervention.
This is measured by TUG (measured 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.
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Baseline, 4 months, 6 months, and 12 months
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30-second chair stand
Time Frame: Baseline, 4 months, 6 months, and 12 months
|
Reflects change in lower-extremity strength with intervention.
This is measured by a 30-second chair stand test.
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Baseline, 4 months, 6 months, and 12 months
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Dual-task walking
Time Frame: Baseline, 4 months, 6 months, and 12 months
|
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.
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.
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Baseline, 4 months, 6 months, and 12 months
|
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Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline, 4 months, 6 months, and 12 months
|
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.
|
Baseline, 4 months, 6 months, and 12 months
|
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Trail Making (A, B)
Time Frame: Baseline, 4 months, 6 months, and 12 months
|
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.
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Baseline, 4 months, 6 months, and 12 months
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Category Fluency
Time Frame: Baseline, 4 months, 6 months, and 12 months
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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.
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Baseline, 4 months, 6 months, and 12 months
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Forward Digit Span
Time Frame: Baseline, 4 months, 6 months, and 12 months
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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.
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Baseline, 4 months, 6 months, and 12 months
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Backward Digit Span
Time Frame: Baseline, 4 months, 6 months, and 12 months
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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.
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Baseline, 4 months, 6 months, and 12 months
|
|
Proportion of fallers
Time Frame: At 6 months
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Number of fallers from the participants in each intervention group
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At 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activity-specific Balance Confidence (ABC)
Time Frame: Baseline, 4 months, 6 months, and 12 months
|
Reflects change in the perceptions of balance with intervention.
This is measured by the ABC scale which assesses one's confidence in performing various activities of daily living without compromising one's balance.
It includes such items as picking up an object from the floor, standing on a chair to reach, and walking on icy sidewalks.
The scale contains 16 items scored on a range from 0% to 100% (0 indicating no confidence and 100 indicating full confidence).
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Baseline, 4 months, 6 months, and 12 months
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Pittsburgh Sleep Quality Index
Time Frame: Baseline, 4 months, 6 months, and 12 months
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Reflects change in quality of sleep with intervention.
This is measured by the Pittsburgh Sleep Quality Index which 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 sleep 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, 4 months, 6 months, and 12 months
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Geriatric Depression Scale
Time Frame: Baseline, 4 months, 6 months, and 12 months
|
Reflects change in the level of depression with intervention.
This is measured by GDS.
The 15-item version of the GDS will be used with the scores ranging from 0 to 15.
A score of 0 to 4 is considered to be within the normal range, 5 to 9 indicates mild depression, and a score of 10 or more indicates moderate to severe depression.
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Baseline, 4 months, 6 months, and 12 months
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EuroQol EQ-5D
Time Frame: Baseline, 4 months, 6 months, and 12 months
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Reflects change in quality of life with intervention.
This is measured by EuroQol EQ-5D which assesses health status in five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each domain is measured at three levels: no problems (coded as 1), some problems (2), and extreme problems (3).
An EQ-5D utility score will be calculated for each participant based on the U.S. population-based (preference-weighted) health index scores on a scale ranging from less than 0 (worst health state) to 1.0 (best or perfect health state).
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Baseline, 4 months, 6 months, and 12 months
|
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Frailty Questionnaire
Time Frame: Baseline, 4 months, 6 months, and 12 months
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Reflects change in frailty with intervention.
Frailty is measured by the Frailty Questionnaire which assesses 5 components: Fatigue, Resistance, Ambulation, Illness, and Loss of Weight.
The scale scores range from 0 to 5 (i.e., 1 point for each component; 0=best to 5=worst) and represent frail (3-5), pre-frail (1-2), and robust (0) health status
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Baseline, 4 months, 6 months, and 12 months
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International Physical Activity Questionnaire
Time Frame: Baseline, 4 months, 6 months, and 12 months
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Reflects change in physical activity with intervention.
Total weekly minutes spent in vigorous physical activity (PA) and moderate PA will be measured.
Two self-report PA measures will be calculated: total weekly minutes of vigorous + moderate PA in bouts of ≥10 min, excluding walking (MVPA) and total weekly minutes of walking in bouts of ≥10 min (Walk).
We will report Total PA (MVPA + Walk), which is conceptually the same construct as accelerometry MVPA in ≥10 min bouts.
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Baseline, 4 months, 6 months, and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 29, 2023
Primary Completion (Estimated)
March 30, 2029
Study Completion (Estimated)
March 31, 2029
Study Registration Dates
First Submitted
April 10, 2023
First Submitted That Met QC Criteria
April 10, 2023
First Posted (Actual)
April 20, 2023
Study Record Updates
Last Update Posted (Actual)
February 3, 2026
Last Update Submitted That Met QC Criteria
January 30, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- R01AG081206 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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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