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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT06918678
Study groupRoleWhat they receive
Tai Chi intervention conditionExperimental(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 conditionActive comparatorThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted9 Apr 2025
  2. Study start20 Mar 2023
  3. Primary completion30 Oct 2023
  4. Study completion30 Oct 2023

Resources

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)
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

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.

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