AgingNCT06918678
Feasibility and Efficacy of A Remote Tai Chi Program in Older Adults
A study testing Tai Chi intervention in people with Aging, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
This project is designed to explore the feasibility and preliminary efficacy of a remote Tai Chi program on older adults' 24-hour movement behaviors (i.e., physical activity, sedentary behavior and sleep patterns). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Tai Chi intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Eligible participants met the following inclusion criteria: 1) aged 60 years or older; 2) basic English communication skills; 3) without cognitive impairments or physical/mental dis-abilities that might limit their ability to practice TC, 4) computer/smartphone with internet access; and 5) provided informed consent. Participants who lacked the capacity to consent or had any medical condition that could make it potentially unsafe to be in an unsupervised physical space were excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Twin Cities
Minneapolis, Minnesota, 55455
About this study
Official title: Feasibility and Preliminary Efficacy of Remotely Delivered Tai Chi on Older Adults' 24-Hour Movement Behaviors: A Crossover Randomized Controlled Trial
This project is designed to explore the feasibility and preliminary efficacy of a remote Tai Chi program on older adults' 24-hour movement behaviors (i.e., physical activity, sedentary behavior and sleep patterns).
Read the detailed description
This study employed a 26-week cross-over, randomized control trial design in which each participant was assigned to one of two condition (i.e., 10 participants/cohort, 2 cohorts/condition) sequences at baseline: 1) the Tai Chi intervention condition then the usual care condition; or 2) usual care condition then intervention condition. The intervention condition requested participants participate in remote Tai Chi program for 60 minutes/session 2 times/week beyond their usual care. The usual care condition asked participants to maintain regular activities without Tai Chi and not to change their regular activity routine. Each condition lasted 12 weeks, with a 2-week washout separating treatments. The researchers monitored intervention fidelity via monthly follow-up phone calls.
- Conditions
- Aging
- Being tested
- Tai Chi intervention, Usual care condiition
- Keywords
- Physical activity, Tai Chi, Quality of life, Sedentary behaviors, Sleep, 24-hour Movement Behaviors, Fear of Falling, Psychosocial Beliefs of Physical Activity, Subjective Psychological Well-being, Cognitive Flexibility
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi interventionDevice
The Tai Chi program was delivered virtually via Zoom by a certified Tai Chi instructor for 12 weeks. Tai Chi forms employed in the class was adapted from an evident-based fall prevention program - Tai Ji Quan: Moving for Better Balance. This program is a research-based Tai Chi balance training regimen. The program composed of core adapted Tai Chi movements and various therapeutic movements as well as breathing exercises
Usual care condiitionOther
In the usual care condition, the investigators requested that participants maintain their regular activities during their time in the usual care condition. The participants were encouraged to refrain from Tai Chi, but not prohibited from engaging in Tai Chi, in the usual care period.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi intervention condition | Experimental | (1) the Tai Chi intervention condition followed by the Usual Care condition, or (2) the Usual Care condition followed by the TC intervention condition. Participants in the Tai Chi intervention condition were asked to attend a remotely delivered Tai Chi program, consisting of two 60-minute sessions each week. The Usual Care condition required participants to maintain their regular activities without Tai Chi and not to change their routine. Each condition lasted 12 weeks with a 2-week washout period separating the conditions to minimize carryover effects. Receives: Device: Tai Chi intervention |
| Usual Care condition | Active comparator | The Usual Care condition required participants to maintain their regular activities without Tai Chi and not to change their routine. Receives: Other: Usual care condiition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and feasibility
The investigators tracked participants' online attendance and let them complete a post-intervention satisfaction survey to assess acceptability and feasibility of the program. After the intervention, the investigators distributed a satisfaction survey including multiple choice questions and open-ended questions to the participants to evaluate their satisfaction and acceptability of the program.
Measured: Baseline, week 13, week 14, and week 26
Secondary outcomes (8)
Physical activity
Fitbit Inspire 3 Tracker owned by Google (Mountain View, California), a commercially available accelerometer-based activity tracker, was used to evaluate 24-hour movement behaviors. The participants received the device by mail, and the Fitbit tracker was given to the participants as an incentive to complete the study. The participants were encouraged to wear the Fitbit on their non-dominant wrist throughout the day, except for battery charging of the device, showering, and deep-water activities. The Inspire 3 tracked participants' physical activity (lightly active, fairly active, and very active).
Measured: Baseline, week 12, week 14, and week 26
Sedentary time
Fitbit Inspire 3 Tracker owned by Google (Mountain View, California), a commercially available accelerometer-based activity tracker, was used to evaluate 24-hour movement behaviors. The participants received the device by mail, and the Fitbit tracker was given to the participants as an incentive to complete the study. The participants were encouraged to wear the Fitbit on their non-dominant wrist throughout the day, except for battery charging of the device, showering, and deep-water activities. The Inspire 3 tracked participants' sedentary time.
Measured: Baseline, week 12, week 14, and week 26
Sleep
Fitbit Inspire 3 Tracker owned by Google (Mountain View, California), a commercially available accelerometer-based activity tracker, was used to evaluate 24-hour movement behaviors. The participants received the device by mail, and the Fitbit tracker was given to the participants as an incentive to complete the study. The participants were encouraged to wear the Fitbit on their non-dominant wrist throughout the day, except for battery charging of the device, showering, and deep-water activities. The Inspire 3 tracked participants' sleep.
Measured: Baseline, week 12, week 14, and week 26
Fear of Falling
A shortened version of the Falls Efficacy Scale-International (Short FES-I) was used to assess fear of falling. This 7-item short FES-I has demonstrated excellent reliability (Cronbach's alpha 0.92) comparable to the original 16-item FES-I. The seven items evaluate the concerns of falling when carrying out daily activities such as getting dressed, taking a bath, or going out to a social event. Each item was rated on a 4-point Likert scale (1= "Not at all concerned" to 4= "Very concerned"). The total scores are summed from the questionnaire, and range from 7-28, with higher scores indicating more concerns about falling.
Measured: Baseline, week 12, week 14, and week 26
Older People's Quality of Life
Quality of life was assessed by the brief Older People's Quality of Life questionnaire also known as the OPQOL-BRIEF. The OPQOL-BRIEF questionnaire has 13 items, with a preliminary single item on global quality of life. Each of the 13 items is scored Strongly agree=1, Agree=2, Neither=3, Disagree=4, Strongly disagree=5. The items are summed for a total OPQOL-Brief score, then positive items are reverse coded, so that higher scores represented higher quality of life.
Measured: Baseline, week 12, week 14, and week 26
Psychosocial Beliefs of Physical Activity
Brief Psychosocial Scales [40] were used to assess psychosocial beliefs towards physical activity (PA). The four scales selected were: PA pros and cons (decisional balance, 8 items), PA self-efficacy (measuring confidence in PA, 6 items), PA social support (5 items), and PA enjoyment (4 items). All of these scales used a 5-point Likert format (1=not important, 5= extremely important). The PA decisional balance scale rates the importance of each statement to an individual's decision to be more active, with a higher score indicating more positive attitudes toward PA. A higher score on the PA self-efficacy, PA social support and PA enjoyments scales indicate more self-confidence, social support, and enjoyment during PA, respectively .
Measured: Baseline, week 12, week 14, and week 26
Cognitive Flexibility
Card sorting, such as Wisconsin Card Sorting (WCS), has been often used to evaluate cognitive flexibility among older adults]. However, WCS takes approximately 30 minutes for older adults to complete, and it has been criticized for the potential stress it may cause older adults. Therefore, the investigators have adopted an online digital card sorting game (EFgo™), to assess participants' cognitive flexibility. The final score (ranging 0 -100, taking both trial accuracy and response time into account using a proprietary algorithm) of each participant was sent to the online database and retrieved by a research assistant for analysis.
Measured: Baseline, week 12, week 14, and week 26
Subjective Psychological Well-being
Psychological wellbeing was assessed using the World Health Organization-Five Well-Being Index (WHO-5) scale remotely. The WHO-5 is a self-report instrument measuring mental well-being consisting of five statements relating to the past two weeks where each statement is rated on a 6-point scale, with higher scores indicating better mental well-being.
Measured: Baseline, week 12, week 14, and week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start20 Mar 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Principal investigator, Zan Gao, The University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918678
- Sponsor's protocol ID
- STUDY00017966
- Status last verified
- Apr 2025
- First submitted
- 21 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of Remotely Delivered Tai Chi on Older Adults' 24-Hour Movement Behaviors: A Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06918678
- Acronym / sponsor ID
- STUDY00017966
- Conditions
- Aging
- Keywords
- Physical activity, Tai Chi, Quality of life, Sedentary behaviors, Sleep, 24-hour Movement Behaviors, Fear of Falling, Psychosocial Beliefs of Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 9 Apr 2025 (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.
This project is designed to explore the feasibility and preliminary efficacy of a remote Tai Chi program on older adults' 24-hour movement behaviors (i.e., physical activity, sedentary behavior and sleep patterns).
Detailed description
This study employed a 26-week cross-over, randomized control trial design in which each participant was assigned to one of two condition (i.e., 10 participants/cohort, 2 cohorts/condition) sequences at baseline: 1) the Tai Chi intervention condition then the usual care condition; or 2) usual care condition then intervention condition. The intervention condition requested participants participate in remote Tai Chi program for 60 minutes/session 2 times/week beyond their usual care. The usual care condition asked participants to maintain regular activities without Tai Chi and not to change their regular activity routine. Each condition lasted 12 weeks, with a 2-week washout separating treatments. The researchers monitored intervention fidelity via monthly follow-up phone calls.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi intervention condition | Experimental | Device: Tai Chi intervention(1) the Tai Chi intervention condition followed by the Usual Care condition, or (2) the Usual Care condition followed by the TC intervention condition. Participants in the Tai Chi intervention condition were asked to attend a remotely delivered Tai Chi program, consisting of two 60-minute sessions each week. The Usual Care condition required participants to maintain their regular activities without Tai Chi and not to change their routine. Each condition lasted 12 weeks with a 2-week washout period separating the conditions to minimize carryover effects. |
| Usual Care condition | Active comparator | Other: Usual care condiitionThe Usual Care condition required participants to maintain their regular activities without Tai Chi and not to change their routine. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Tai Chi interventionThe Tai Chi program was delivered virtually via Zoom by a certified Tai Chi instructor for 12 weeks. Tai Chi forms employed in the class was adapted from an evident-based fall prevention program - Tai Ji Quan: Moving for Better Balance. This program is a research-based Tai Chi balance training regimen. The program composed of core adapted Tai Chi movements and various therapeutic movements as well as breathing exercises | Device | Tai Chi intervention condition |
| Usual care condiitionIn the usual care condition, the investigators requested that participants maintain their regular activities during their time in the usual care condition. The participants were encouraged to refrain from Tai Chi, but not prohibited from engaging in Tai Chi, in the usual care period. | Other | Usual Care condition |
Primary outcome
Acceptability and feasibility
Time frame: Baseline, week 13, week 14, and week 26
The investigators tracked participants' online attendance and let them complete a post-intervention satisfaction survey to assess acceptability and feasibility of the program. After the intervention, the investigators distributed a satisfaction survey including multiple choice questions and open-ended questions to the participants to evaluate their satisfaction and acceptability of the program.
8 secondary outcomes
Physical activity
Time frame: Baseline, week 12, week 14, and week 26
Sedentary time
Time frame: Baseline, week 12, week 14, and week 26
Sleep
Time frame: Baseline, week 12, week 14, and week 26
Fear of Falling
Time frame: Baseline, week 12, week 14, and week 26
Older People's Quality of Life
Time frame: Baseline, week 12, week 14, and week 26
Psychosocial Beliefs of Physical Activity
Time frame: Baseline, week 12, week 14, and week 26
Cognitive Flexibility
Time frame: Baseline, week 12, week 14, and week 26
Subjective Psychological Well-being
Time frame: Baseline, week 12, week 14, and week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi intervention in people with Aging, run by The University of Tennessee, Knoxville 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?
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 9 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptability and feasibility (time frame: Baseline, week 13, week 14, and week 26). 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 9 Apr 2025.