- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06918678
Feasibility and Efficacy of A Remote Tai Chi Program in Older Adults
April 6, 2025 updated by: Zan Gao, The University of Tennessee, Knoxville
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
35
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 Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota, Twin Cities
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
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: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tai Chi intervention condition
(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.
|
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
|
|
Active Comparator: Usual Care condition
The Usual Care condition required participants to maintain their regular activities without Tai Chi and not to change their routine.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, week 13, week 14, and week 26
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: Baseline, week 12, week 14, and week 26
|
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).
|
Baseline, week 12, week 14, and week 26
|
|
Sedentary time
Time Frame: Baseline, week 12, week 14, and week 26
|
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.
|
Baseline, week 12, week 14, and week 26
|
|
Sleep
Time Frame: Baseline, week 12, week 14, and week 26
|
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.
|
Baseline, week 12, week 14, and week 26
|
|
Fear of Falling
Time Frame: Baseline, week 12, week 14, and week 26
|
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.
|
Baseline, week 12, week 14, and week 26
|
|
Older People's Quality of Life
Time Frame: Baseline, week 12, week 14, and week 26
|
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.
|
Baseline, week 12, week 14, and week 26
|
|
Psychosocial Beliefs of Physical Activity
Time Frame: Baseline, week 12, week 14, and week 26
|
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 .
|
Baseline, week 12, week 14, and week 26
|
|
Cognitive Flexibility
Time Frame: Baseline, week 12, week 14, and week 26
|
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.
|
Baseline, week 12, week 14, and week 26
|
|
Subjective Psychological Well-being
Time Frame: Baseline, week 12, week 14, and week 26
|
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.
|
Baseline, week 12, week 14, and week 26
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
March 20, 2023
Primary Completion (Actual)
October 30, 2023
Study Completion (Actual)
October 30, 2023
Study Registration Dates
First Submitted
March 21, 2025
First Submitted That Met QC Criteria
April 6, 2025
First Posted (Actual)
April 9, 2025
Study Record Updates
Last Update Posted (Actual)
April 9, 2025
Last Update Submitted That Met QC Criteria
April 6, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00017966
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
Clinical Trials on Aging
-
Florida Institute for Human and Machine CognitionNot yet recruitingAging | Healthy Aging | Aging WellUnited States
-
Tuba MadenCompletedAging | Aging Problems | Aging Disorder
-
University of CopenhagenRecruitingAging | Healthy Aging | Aging FrailtyDenmark
-
Radboud University Medical CenterTerminated
-
Northwestern UniversityPotocsnak Human Longevity LabRecruitingAging | Aging Well | Aging, Biological | Aging, HealthyUnited States
-
Centre Hospitalier Universitaire de NiceNot yet recruitingAging | Aging, HealthyFrance
-
University of Santiago de CompostelaEuropean Regional Development Fund; Center for Industrial Technological Development...Completed
-
TruDiagnosticBlushield USANot yet recruitingAging | Aging Well
-
Arizona State UniversityActive, not recruiting
-
San Diego State UniversityCompleted
Clinical Trials on Tai Chi intervention
-
Chengdu University of Traditional Chinese MedicineNot yet recruitingQuality of Life | Dialysis; Complications | Chinese Medicine
-
Edward Via Virginia College of Osteopathic MedicineNational Center for Complementary and Integrative Health (NCCIH); The University...CompletedKnee OsteoarthritisUnited States
-
VA Office of Research and DevelopmentBoston University; Tufts Medical CenterCompleted
-
Appalachian State UniversityCompleted
-
The University of Hong KongQueen Mary Hospital, Hong KongRecruitingTai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer PatientsAdvanced Lung Non-Small Cell CarcinomaHong Kong
-
Assistance Publique - Hôpitaux de ParisRecruitingChronic Somatoform Disorders in AdolescentsFrance
-
Beni-Suef UniversityRecruiting
-
Harvard University Faculty of MedicineBeth Israel Deaconess Medical Center; Brigham and Women's HospitalCompleted
-
Beijing Anzhen HospitalNot yet recruitingRenal Insufficiency | Coronary Heart Disease (CHD)China
-
Angus YuThe University of Hong Kong; Chinese University of Hong Kong; Food and Health...Completed