Tai JiNCT03659396
the Effects of Individualized Tai Chi Training on Balance Control in Elderly
A study testing individualized Tai Chi, Entire Tai Chi and home-based program in people with Tai Ji, run by National Yang Ming Chiao Tung University.
Trial summary
Traditional Tai Chi is too complex for most elderly individuals. There have been few reports regarding the development of simplified Tai Chi programs to suit the physical needs of elderly adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tai Ji
- What is being tested?
- individualized Tai Chi, Entire Tai Chi and home-based program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Jul 2014
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participants in the study were community-dwelling volunteers aged over 65 years. Participants were ambulatory and did not
Who cannot join
- have any history of
- diagnosed central nervous system
- vestibular pathology
- cognitive impairment
- visual deficit
- fracture of lower limb in recent 6 months
- with Tai Chi practice experience for more than 2 months.
- severe hearing impairment to follow instruction
About this study
Traditional Tai Chi is too complex for most elderly individuals. There have been few reports regarding the development of simplified Tai Chi programs to suit the physical needs of elderly adults. However, these programs were not individualized according to the participants' balance control abilities.The investigators already developed an individualized Tai Chi program. This objective of the study was to investigate the effect of individualized Tai Chi training.
Read the detailed description
Background: Balance control is an important skill for human to maintain a myriad of postures and activities. The elderly suffering from balance impairment by aging have high rate to increase fall-related injuries, restricted activities, declined physical functions, and decrease quality of life. Tai Chi (TC) has been demonstrated as an innovative way to promote balance function, which is a suitable exercise for older people because of its slow movement, changeable base of supports, multi-directions weight shifting and less impact on lower extremities. Recent systematic reviews have shown that TC exercises have significant benefits in improving balance control, but most of them are only connected with healthy elderlies. Actually, the long standing time and training duration, challenged recollection by its sequence forms, and complex coordination for upper and lower extremities of TC usually make it difficult to practice for some elderlies with poor physical functions. Therefore, the method of individualized TC exercise program, integrated with biomechanical analyses, is developed in this research. It can afford an easier and more applicable training for elderly to improve the balance abilities.
Purposes:To evaluate the effects of individualized Tai Chi training on balance control in elderly.
Methods: This research is a quasi-experimental design and prospective study. Participants were recruited and assigned into individualized TC, entire TC group and home-based education group
- Conditions
- Tai Ji
- Being tested
- individualized Tai Chi, Entire Tai Chi, home-based program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized Tai ChiOther
individualized Tai Chi training exercise
Entire Tai ChiOther
the classical Yang style Tai Chi program
home-based programOther
Home-based exercise
| Study group | Role | What they receive |
|---|---|---|
| individualized Tai Chi | Experimental | patient received individualized Tai Chi program training. Receives: Other: individualized Tai Chi |
| Entire Tai Chi | Active comparator | patient received Entire Tai Chi program training. Receives: Other: Entire Tai Chi |
| home-based program | Placebo comparator | patient received home-based program training. Receives: Other: home-based program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Up and Go
is a simple test used to assess a person's mobility and requires both static and dynamic balance
Measured: 8 weeks
Secondary outcomes (6)
Berg balance scale
The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks. 1 The scale consists of 14 items, scored from 0 to 4, which are added to make a total score between 0 and 56; a higher score indicates better balance.
Measured: 8 weeks
functional reach
The Functional Reach Test is a quick and simple, single-task dynamic test that defines functional reach as. "the maximal distance one can reach forward beyond arm's length, while maintaining a fixed base of support in the standing position"
Measured: 8 weeks
muscle strength of hip flexor and extensor
muscle strength of hip flexor and extensor by dynamometer
Measured: 8 weeks
muscle strength of hip abductor and adductor
muscle strength of hip abductor and adductor by dynamometer
Measured: 8 weeks
muscle strength of knee flexor and extensor
muscle strength of knee flexor and extensor by dynamometer
Measured: 8 weeks
muscle strength of ankle dorsiflexor and plantarflexor
muscle strength of ankle dorsiflexor and plantarflexor by dynamometer
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study startDec 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tai JiStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Hsu Sung, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659396
- Sponsor's protocol ID
- 1000087
- Status last verified
- Sep 2018
- First submitted
- 28 Mar 2017
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Penn IW, Sung WH, Lin CH, Chuang E, Chuang TY, Lin PH. Effects of individualized Tai-Chi on balance and lower-limb strength in older adults. BMC Geriatr. 2019 Aug 27;19(1):235. doi: 10.1186/s12877-019-1250-8.
PubMed 31455225
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effects of Individualized Tai Chi Training on Balance Control in Elderly
- ClinicalTrials.gov ID
- NCT03659396
- Acronym / sponsor ID
- 1000087
- Conditions
- Tai Ji
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Sep 2018 (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.
Traditional Tai Chi is too complex for most elderly individuals. There have been few reports regarding the development of simplified Tai Chi programs to suit the physical needs of elderly adults. However, these programs were not individualized according to the participants' balance control abilities.The investigators already developed an individualized Tai Chi program. This objective of the study was to investigate the effect of individualized Tai Chi training.
Detailed description
Background: Balance control is an important skill for human to maintain a myriad of postures and activities. The elderly suffering from balance impairment by aging have high rate to increase fall-related injuries, restricted activities, declined physical functions, and decrease quality of life. Tai Chi (TC) has been demonstrated as an innovative way to promote balance function, which is a suitable exercise for older people because of its slow movement, changeable base of supports, multi-directions weight shifting and less impact on lower extremities. Recent systematic reviews have shown that TC exercises have significant benefits in improving balance control, but most of them are only connected with healthy elderlies. Actually, the long standing time and training duration, challenged recollection by its sequence forms, and complex coordination for upper and lower extremities of TC usually make it difficult to practice for some elderlies with poor physical functions. Therefore, the method of individualized TC exercise program, integrated with biomechanical analyses, is developed in this research. It can afford an easier and more applicable training for elderly to improve the balance abilities.
Purposes:To evaluate the effects of individualized Tai Chi training on balance control in elderly.
Methods: This research is a quasi-experimental design and prospective study. Participants were recruited and assigned into individualized TC, entire TC group and home-based education group
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| individualized Tai Chi | Experimental | Other: individualized Tai Chipatient received individualized Tai Chi program training. |
| Entire Tai Chi | Active comparator | Other: Entire Tai Chipatient received Entire Tai Chi program training. |
| home-based program | Placebo comparator | Other: home-based programpatient received home-based program training. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Participants in the study were community-dwelling volunteers aged over 65 years. Participants were ambulatory and did not
Key exclusion criteria (8 listed)
- have any history of
- diagnosed central nervous system
- vestibular pathology
- cognitive impairment
- visual deficit
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 |
|---|---|---|
| individualized Tai Chiindividualized Tai Chi training exercise | Other | individualized Tai Chi |
| Entire Tai Chithe classical Yang style Tai Chi program | Other | Entire Tai Chi |
| home-based programHome-based exercise | Other | home-based program |
Primary outcome
Time Up and Go
Time frame: 8 weeks
is a simple test used to assess a person's mobility and requires both static and dynamic balance
6 secondary outcomes
Berg balance scale
Time frame: 8 weeks
functional reach
Time frame: 8 weeks
muscle strength of hip flexor and extensor
Time frame: 8 weeks
muscle strength of hip abductor and adductor
Time frame: 8 weeks
muscle strength of knee flexor and extensor
Time frame: 8 weeks
muscle strength of ankle dorsiflexor and plantarflexor
Time frame: 8 weeks
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 10 Sep 2018.
- Derived from this study: PubMed 31455225Penn IW, Sung WH, Lin CH, Chuang E, Chuang TY, Lin PH. Effects of individualized Tai-Chi on balance and lower-limb strength in older adults. BMC Geriatr. 2019 Aug 27;19(1):235. doi: 10.1186/s12877-019-1250-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing individualized Tai Chi, Entire Tai Chi and home-based program in people with Tai Ji, run by National Yang Ming Chiao Tung University.
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 8 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: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Time Up and Go (time frame: 8 weeks). 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 NCT03659396, which also lists 1 linked publication.
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 10 Sep 2018.