Gait DisorderNCT06046911
Effects of Tai Chi on Postural Balance and Quality of Life in the Elderly With Gait Disorder
A study testing Tai Chi and Daily activity group in people with Gait Disorder and Postural Balance, run by Universiti Putra Malaysia at 1 site in China.
Trial summary
The goal of this intervention study was to test balance ability and quality of life in older adults with gait problems. The main questions it aims to answer are: 1. Can the balance ability of elderly people with gait disorders be improved through Tai Chi intervention? 2. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait Disorder, Postural Balance
- What is being tested?
- Tai Chi and Daily activity group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2023to Dec 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years old Have mild gait problems Can walk independently No Tai Chi training experience or exercise habits
Who cannot join
- Age <60 years old No obvious problems with gait walking with tools Have experience in Tai Chi intervention within three months hearing loss
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Binhe Sports Center
Taiyuan, Shanxi, 030000
Fan Xu, PHD, 8615835664633, gs62396@student.upm.edu.my
Jia Lu Zhang, Master, 13834511160, 924258993@qq.com
About this study
Official title: Effects of Tai Chi on Postural Balance and Quality of Life Among Elderly With Gait Disorders in China
The goal of this intervention study was to test balance ability and quality of life in older adults with gait problems. The main questions it aims to answer are: 1. Can the balance ability of elderly people with gait disorders be improved through Tai Chi intervention? 2. Whether Tai Chi intervention can improve the quality of life of elderly people with gait disorders.
Participants will be divided into an experimental group and a control group. The experimental group will undergo 12 weeks of Tai Chi intervention, while the control group will maintain daily habits, including simple walking or stretching activities.
Read the detailed description
The inclusion criteria for potential participants were as follows:
Age ≥ 60 years old Have mild gait problems Can walk independently No Tai Chi training experience or exercise habits
The exclusion criteria for potential participants were as follows:
Age <60 years old No obvious problems with gait walking with tools Have experience in Tai Chi intervention within three months hearing loss
Outcomes measured: balance, gait, muscle strength, mobility, fall rate, quality of life.
- Conditions
- Gait Disorder, Postural Balance
- Being tested
- Tai Chi, Daily activity group
- Keywords
- Tai Chi, Balance, Gait, Quality of life, Muscle strength
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiOther
In this study, Tai Chi has a total of 24 movements, which are connected step by step according to the principles of sports training.
Daily activity groupOther
The daily activity group does not receive special intervention, and the subjects must maintain their daily habits and complete the 12-week test.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi group | Experimental | The intervention was 12 weeks of Yang-style Tai Chi, three times a week. Receives: Other: Tai Chi |
| Daily activity group | Experimental | The daily activity group mainly maintained daily activities, such as walking and stretching, three times a week for 12 weeks. Receives: Other: Daily activity group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of 12 weeks of Tai Chi intervention on balance ability in the elderly
The main test method is the single-leg eyes-closed test
Measured: The balance ability of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
Effects of 12 weeks of Tai Chi intervention on gait speed of the elderly
Gait speed measurement mainly uses the four-meter walking test
Measured: The gait speed of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
Effects of 12 weeks of Tai Chi intervention on gait skills
Gait skill measurement mainly uses the figure-8 walking test
Measured: The gait skills of the elderly were tested before the intervention and at 6 and 12 weeks after the intervention
Effects of 12-week Tai Chi intervention on mobility of the elderly
Time Up and Go measures mobility
Measured: The Mobility of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
Effects of 12 weeks of Tai Chi intervention on upper limb muscle strength in the elderly
Grip strength test upper limb muscle strength
Measured: The upper limb muscle strength of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
Effects of 12 weeks of Tai Chi intervention on lower limb muscle strength in the elderly
30s chair test to measure lower limb muscle strength
Measured: The lower limb muscle strength of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
Effect of 12-week Tai Chi intervention on fall risk in the elderly
Time Up and Go measures Fall risk
Measured: The Fall risk of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
Effects of 12-week Tai Chi intervention on the quality of life of the elderly
Measured using Questionnaire, 36-Item Short Form Surve (SF-36) Scale
Measured: The Quality of life of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 Sep 2023
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gait DisorderStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this experiment, the experimental group will practice Yang Style Tai Chi.The control group will be the daily activity group, maintaining daily activities such as walking. There are males and females in each parallel group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XU FAN, Universiti Putra Malaysia
- Investigators
- Fan Xu, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046911
- Sponsor's protocol ID
- Xu Fan
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borowicz A, Zasadzka E, Gaczkowska A, Gawlowska O, Pawlaczyk M. Assessing gait and balance impairment in elderly residents of nursing homes. J Phys Ther Sci. 2016 Sep;28(9):2486-2490. doi: 10.1589/jpts.28.2486. Epub 2016 Sep 29.
PubMed 27799676Chang JH, Koo M, Wu SW, Chen CY. Effects of a 12-week program of Tai Chi exercise on the kidney disease quality of life and physical functioning of patients with end-stage renal disease on hemodialysis. Complement Ther Med. 2017 Feb;30:79-83. doi: 10.1016/j.ctim.2016.12.002. Epub 2016 Dec 7.
PubMed 28137531Taylor-Piliae RE, Haskell WL, Waters CM, Froelicher ES. Change in perceived psychosocial status following a 12-week Tai Chi exercise programme. J Adv Nurs. 2006 May;54(3):313-29. doi: 10.1111/j.1365-2648.2006.03809.x.
PubMed 16629916Huang SL, Hsieh CL, Wu RM, Tai CH, Lin CH, Lu WS. Minimal detectable change of the timed "up & go" test and the dynamic gait index in people with Parkinson disease. Phys Ther. 2011 Jan;91(1):114-21. doi: 10.2522/ptj.20090126. Epub 2010 Oct 14.
PubMed 20947672Ke XH, Huang DB, Li YY, Li XM, Guo JH, Guo MM, Yu SX, Ma SC, Jiang C, Lin ZH. Effects of 12 weeks of Tai Chi Chuan intervention on the postural stability and self-reported instability in subjects with functional ankle instability: Study protocol for a randomized controlled trial. Front Neurol. 2022 Sep 21;13:923669. doi: 10.3389/fneur.2022.923669. eCollection 2022.
PubMed 36212637Perez-Cruzado D, Gonzalez-Sanchez M, Cuesta-Vargas AI. Parameterization and reliability of single-leg balance test assessed with inertial sensors in stroke survivors: a cross-sectional study. Biomed Eng Online. 2014 Aug 30;13:127. doi: 10.1186/1475-925X-13-127.
PubMed 25174611Soke F, Demirkaya S, Gulsen C, Yavuz N, Karakoc S, Ozcan Gulsen E, Yilmaz O, Kocer B, Kurtulus Aydin F, Yucesan C. The figure-of-eight walk test is a reliable and valid test for assessing walking skill in people with multiple sclerosis. Mult Scler Relat Disord. 2022 Nov;67:104099. doi: 10.1016/j.msard.2022.104099. Epub 2022 Aug 9.
PubMed 35969935Taylor-Piliae RE, Hoke TM, Hepworth JT, Latt LD, Najafi B, Coull BM. Effect of Tai Chi on physical function, fall rates and quality of life among older stroke survivors. Arch Phys Med Rehabil. 2014 May;95(5):816-24. doi: 10.1016/j.apmr.2014.01.001. Epub 2014 Jan 17.
PubMed 24440643
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tai Chi on Postural Balance and Quality of Life Among Elderly With Gait Disorders in China
- ClinicalTrials.gov ID
- NCT06046911
- Acronym / sponsor ID
- Xu Fan
- Conditions
- Gait Disorder, Postural Balance
- Keywords
- Tai Chi, Balance, Gait, Quality of life, Muscle strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Sep 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.
The goal of this intervention study was to test balance ability and quality of life in older adults with gait problems. The main questions it aims to answer are: 1. Can the balance ability of elderly people with gait disorders be improved through Tai Chi intervention? 2. Whether Tai Chi intervention can improve the quality of life of elderly people with gait disorders.
Participants will be divided into an experimental group and a control group. The experimental group will undergo 12 weeks of Tai Chi intervention, while the control group will maintain daily habits, including simple walking or stretching activities.
Detailed description
The inclusion criteria for potential participants were as follows:
Age ≥ 60 years old Have mild gait problems Can walk independently No Tai Chi training experience or exercise habits
The exclusion criteria for potential participants were as follows:
Age <60 years old No obvious problems with gait walking with tools Have experience in Tai Chi intervention within three months hearing loss
Outcomes measured: balance, gait, muscle strength, mobility, fall rate, quality of life.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In this experiment, the experimental group will practice Yang Style Tai Chi.The control group will be the daily activity group, maintaining daily activities such as walking. There are males and females in each parallel group.
| Arm | Type | Receives |
|---|---|---|
| Tai Chi group | Experimental | Other: Tai ChiThe intervention was 12 weeks of Yang-style Tai Chi, three times a week. |
| Daily activity group | Experimental | Other: Daily activity groupThe daily activity group mainly maintained daily activities, such as walking and stretching, three times a week for 12 weeks. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 60 years old Have mild gait problems Can walk independently No Tai Chi training experience or exercise habits
Key exclusion criteria (1 listed)
- Age <60 years old No obvious problems with gait walking with tools Have experience in Tai Chi intervention within three months hearing loss
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 ChiIn this study, Tai Chi has a total of 24 movements, which are connected step by step according to the principles of sports training. | Other | Tai Chi group |
| Daily activity groupThe daily activity group does not receive special intervention, and the subjects must maintain their daily habits and complete the 12-week test. | Other | Daily activity group |
Primary outcome
Effects of 12 weeks of Tai Chi intervention on balance ability in the elderly
Time frame: The balance ability of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
The main test method is the single-leg eyes-closed test
Effects of 12 weeks of Tai Chi intervention on gait speed of the elderly
Time frame: The gait speed of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
Gait speed measurement mainly uses the four-meter walking test
Effects of 12 weeks of Tai Chi intervention on gait skills
Time frame: The gait skills of the elderly were tested before the intervention and at 6 and 12 weeks after the intervention
Gait skill measurement mainly uses the figure-8 walking test
Effects of 12-week Tai Chi intervention on mobility of the elderly
Time frame: The Mobility of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
Time Up and Go measures mobility
Effects of 12 weeks of Tai Chi intervention on upper limb muscle strength in the elderly
Time frame: The upper limb muscle strength of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
Grip strength test upper limb muscle strength
Effects of 12 weeks of Tai Chi intervention on lower limb muscle strength in the elderly
Time frame: The lower limb muscle strength of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
30s chair test to measure lower limb muscle strength
Effect of 12-week Tai Chi intervention on fall risk in the elderly
Time frame: The Fall risk of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
Time Up and Go measures Fall risk
Effects of 12-week Tai Chi intervention on the quality of life of the elderly
Time frame: The Quality of life of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks
Measured using Questionnaire, 36-Item Short Form Surve (SF-36) Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 27799676Borowicz A, Zasadzka E, Gaczkowska A, Gawlowska O, Pawlaczyk M. Assessing gait and balance impairment in elderly residents of nursing homes. J Phys Ther Sci. 2016 Sep;28(9):2486-2490. doi: 10.1589/jpts.28.2486. Epub 2016 Sep 29.
- Background: PubMed 28137531Chang JH, Koo M, Wu SW, Chen CY. Effects of a 12-week program of Tai Chi exercise on the kidney disease quality of life and physical functioning of patients with end-stage renal disease on hemodialysis. Complement Ther Med. 2017 Feb;30:79-83. doi: 10.1016/j.ctim.2016.12.002. Epub 2016 Dec 7.
- Background: PubMed 16629916Taylor-Piliae RE, Haskell WL, Waters CM, Froelicher ES. Change in perceived psychosocial status following a 12-week Tai Chi exercise programme. J Adv Nurs. 2006 May;54(3):313-29. doi: 10.1111/j.1365-2648.2006.03809.x.
- Background: PubMed 20947672Huang SL, Hsieh CL, Wu RM, Tai CH, Lin CH, Lu WS. Minimal detectable change of the timed "up & go" test and the dynamic gait index in people with Parkinson disease. Phys Ther. 2011 Jan;91(1):114-21. doi: 10.2522/ptj.20090126. Epub 2010 Oct 14.
- Background: PubMed 36212637Ke XH, Huang DB, Li YY, Li XM, Guo JH, Guo MM, Yu SX, Ma SC, Jiang C, Lin ZH. Effects of 12 weeks of Tai Chi Chuan intervention on the postural stability and self-reported instability in subjects with functional ankle instability: Study protocol for a randomized controlled trial. Front Neurol. 2022 Sep 21;13:923669. doi: 10.3389/fneur.2022.923669. eCollection 2022.
- Background: PubMed 25174611Perez-Cruzado D, Gonzalez-Sanchez M, Cuesta-Vargas AI. Parameterization and reliability of single-leg balance test assessed with inertial sensors in stroke survivors: a cross-sectional study. Biomed Eng Online. 2014 Aug 30;13:127. doi: 10.1186/1475-925X-13-127.
- Background: PubMed 35969935Soke F, Demirkaya S, Gulsen C, Yavuz N, Karakoc S, Ozcan Gulsen E, Yilmaz O, Kocer B, Kurtulus Aydin F, Yucesan C. The figure-of-eight walk test is a reliable and valid test for assessing walking skill in people with multiple sclerosis. Mult Scler Relat Disord. 2022 Nov;67:104099. doi: 10.1016/j.msard.2022.104099. Epub 2022 Aug 9.
- Background: PubMed 24440643Taylor-Piliae RE, Hoke TM, Hepworth JT, Latt LD, Najafi B, Coull BM. Effect of Tai Chi on physical function, fall rates and quality of life among older stroke survivors. Arch Phys Med Rehabil. 2014 May;95(5):816-24. doi: 10.1016/j.apmr.2014.01.001. Epub 2014 Jan 17.
- Assessment of the 4-meter walk test test-retest reliability and concurrent validity and its correlation with the five sit-to-stand test in chronic ambulatory stroke survivorsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Fan Xu principal investigator
Universiti Putra Malaysia
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 and Daily activity group in people with Gait Disorder and Postural Balance, run by Universiti Putra Malaysia at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fan Xu (86- 15835664633, gs62396@student.upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of 12 weeks of Tai Chi intervention on balance ability in the elderly (time frame: The balance ability of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06046911, which also lists 8 linked publications.
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 21 Sep 2023.