Tai JiNCT04887363
The Comparisons of Effects of Core Stability Exercise and Tai Chi on Core Muscle Performances in Elderly
A study testing Core exercise and Tai Chi exercise in people with Tai Ji, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
Core muscles and core stability has a key component in the postural control or balance. However, no clear evidence has been found for the positive relationship between core stability and postural control in the elderly, and the effects of core stabilizing training on postural control or balance in the elderly. Read more about this study
- Who is it for?
- Ages 20 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Tai Ji
- What is being tested?
- Core exercise and Tai Chi exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2013to 30 Jun 2015
- 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 20 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Core exercise group and Tai Chi exercise group
- healthy community-dwelling older adults (60-74 years old)
- not received any core stability or Tai Chi Chuan training within the previous 6 months
- independent in basic daily living activities
- able to move freely without any assistance
- Young adults group a. Their age should be ranged between 20 - 59 years
Who cannot join
- All group
- have a history of orthopedic surgery on spine or lower extremity
- have any spine pathology (e.g., spondylolisthesis, disc herniation)
- have a pain over back or lower limbs to affect the ability to perform activities of daily living
- had a history of vestibular disease (e.g., Meniere' s disease)
About this study
Official title: The Comparisons of Effects of Core Stability Exercise and Tai Chi on Core Muscle Performances, Core Stability and Balance in Community-living Elderly
Core muscles and core stability has a key component in the postural control or balance. However, no clear evidence has been found for the positive relationship between core stability and postural control in the elderly, and the effects of core stabilizing training on postural control or balance in the elderly. The purposes of this project are to investigate the effects of core stability training program on muscle strength, muscle performance, and balance outcomes in elderly adults.
Read the detailed description
In this pretest, posttest design study, elderly adults enrolled and assigned to the core exercise group or Tai Chi exercise group, the core exercise group received core exercise intervention comparing to Tai Chi exercise group participated Tai chi exercise program as a control group.
The young adults group were also enrolled for a reference group, not received any exercise intervention and just only received the measurements once.
Participants in the two elderly group will receive 12-week, 36-session exercise-based core stability training class. The each 60 minutes core exercise class focuses on exercise for improving strength, endurance of core muscles and trunk stability.
Participants need complete baseline assessments of muscle performance, and balance ability measures 1 week prior and 1 week and 12 weeks following the intervention.
- Conditions
- Tai Ji
- Being tested
- Core exercise, Tai Chi exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core exerciseBehavioural
Participants will receive12-week, 60 minutes, 36-session exercise-based core stability training class. Participants need complete baseline assessments of muscle performance, and balance ability measures 1 week prior and 1 week and 12 weeks following the intervention. All subjects will receive two post-exercise measurements at 13th week and 25th week.
Tai Chi exerciseBehavioural
Participants will receive 12-week, 60 minutes, 36-session Tai Chi exercise training class. Participants need complete baseline assessments of muscle performance, and balance ability measures 1 week prior and 1 week and 12 weeks following the intervention. All subjects will receive two post-exercise measurements at 13th week and 25th week.
| Study group | Role | What they receive |
|---|---|---|
| Core exercise group | Experimental | The healthy community-dwelling older adults (60-74 years old), who had not received any core stability or Tai Chi Chuan training within the previous 6 months, were recruited in this study. All the subjects were independent in basic daily living activities and able to move freely without any assistance. Receives: Behavioral: Core exercise |
| Tai Chi exercise group | Experimental | The healthy community-dwelling older adults (60-74 years old), who had not received any core stability or Tai Chi Chuan training within the previous 6 months, were recruited in this study. All the subjects were independent in basic daily living activities and able to move freely without any assistance. Receives: Behavioral: Tai Chi exercise |
| Young adults group | No intervention | The healthy young adults who have not any neurological, musculoskeletal or rheumatic disease were recruited as a reference group. They would not receive any training program in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in strength of core muscle groups (trunk) at 12-week
Using a custom-made isometric dynamometer to measure the strength of trunk flexors, extensors and rotators
Measured: The assessments will be conducted 1 and 12 weeks following the intervention
Changes in strength of core muscle groups (hip) at 12-week
Using a hand-held dynamometer to measure the hip muscle strength
Measured: The assessments will be conducted 1 and 12 weeks following the intervention
Changes in endurance of core muscle groups at 12-week
Using the Stabilizer Pressure Biofeedback Unit (PBU) during the leg-loading test to measure the endurance of lumbo-pelvic stability
Measured: The assessments will be conducted 1 and 12 weeks following the intervention
Changes in flexibility of the lower back and hamstring muscles at 12-week
Using the sit and reach test to measure the flexibility of the lower back and hamstring muscles
Measured: The assessments will be conducted 1 and 12 weeks following the intervention
Changes in ability of the dynamic balance at 12-week
Using the Dual-tasking 3m Timed up and go (3m-TUG) to measure dynamic balance and the fall risk. Mean time to perform 3m-TUG is 11.56 seconds
Measured: The assessments will be conducted 1 and 12 weeks following the intervention
Changes in assessment of postural control at 12-week
Using a force plate to collect the center of pressure (COP) displacement
Measured: The assessments will be conducted 1 and 12 weeks following the intervention
Changes in muscle activity of selected core muscles during performing arm-raising tasks at 12-week
Using a surface electromyography to record the muscle activity of abdominal and trunk muscles during performing arms-raising tasks with hand-holding 1.5-2 kg
Measured: The assessments will be conducted 1 and 12 weeks following the intervention
Changes in assessment of postural control during performing arm-raising tasks at 12-week
Using a force plate to collect the center of pressure (COP) displacement during performing arms-raising tasks with hand-holding 1.5-2 kg
Measured: The assessments will be conducted 1 and 12 weeks following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start3 Jun 2013
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tai JiStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Jiun Liaw, Study director, Kaohsiung Medical University Department of Physical Therapy Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887363
- Sponsor's protocol ID
- KMUH-IRB-20120427
- Status last verified
- Feb 2021
- First submitted
- 22 Mar 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently in the submission stage ,and then share with other researchers after publication
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparisons of Effects of Core Stability Exercise and Tai Chi on Core Muscle Performances, Core Stability and Balance in Community-living Elderly
- ClinicalTrials.gov ID
- NCT04887363
- Acronym / sponsor ID
- KMUH-IRB-20120427
- Conditions
- Tai Ji
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 3 Jun 2013 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 14 May 2021 (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.
Core muscles and core stability has a key component in the postural control or balance. However, no clear evidence has been found for the positive relationship between core stability and postural control in the elderly, and the effects of core stabilizing training on postural control or balance in the elderly. The purposes of this project are to investigate the effects of core stability training program on muscle strength, muscle performance, and balance outcomes in elderly adults.
Detailed description
In this pretest, posttest design study, elderly adults enrolled and assigned to the core exercise group or Tai Chi exercise group, the core exercise group received core exercise intervention comparing to Tai Chi exercise group participated Tai chi exercise program as a control group.
The young adults group were also enrolled for a reference group, not received any exercise intervention and just only received the measurements once.
Participants in the two elderly group will receive 12-week, 36-session exercise-based core stability training class. The each 60 minutes core exercise class focuses on exercise for improving strength, endurance of core muscles and trunk stability.
Participants need complete baseline assessments of muscle performance, and balance ability measures 1 week prior and 1 week and 12 weeks following the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Core exercise group | Experimental | Behavioral: Core exerciseThe healthy community-dwelling older adults (60-74 years old), who had not received any core stability or Tai Chi Chuan training within the previous 6 months, were recruited in this study. All the subjects were independent in basic daily living activities and able to move freely without any assistance. |
| Tai Chi exercise group | Experimental | Behavioral: Tai Chi exerciseThe healthy community-dwelling older adults (60-74 years old), who had not received any core stability or Tai Chi Chuan training within the previous 6 months, were recruited in this study. All the subjects were independent in basic daily living activities and able to move freely without any assistance. |
| Young adults group | No intervention | –The healthy young adults who have not any neurological, musculoskeletal or rheumatic disease were recruited as a reference group. They would not receive any training program in the study. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Core exercise group and Tai Chi exercise group
- Young adults group a. Their age should be ranged between 20 - 59 years
Key exclusion criteria (5 listed)
- All group
- have a history of orthopedic surgery on spine or lower extremity
- have any spine pathology (e.g., spondylolisthesis, disc herniation)
- have a pain over back or lower limbs to affect the ability to perform activities of daily living
- had a history of vestibular disease (e.g., Meniere' s disease)
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 |
|---|---|---|
| Core exerciseParticipants will receive12-week, 60 minutes, 36-session exercise-based core stability training class. Participants need complete baseline assessments of muscle performance, and balance ability measures 1 week prior and 1 week and 12 weeks following the intervention. All subjects will receive two post-exercise measurements at 13th week and 25th week. | Behavioural | Core exercise group |
| Tai Chi exerciseParticipants will receive 12-week, 60 minutes, 36-session Tai Chi exercise training class. Participants need complete baseline assessments of muscle performance, and balance ability measures 1 week prior and 1 week and 12 weeks following the intervention. All subjects will receive two post-exercise measurements at 13th week and 25th week. | Behavioural | Tai Chi exercise group |
Primary outcome
Changes in strength of core muscle groups (trunk) at 12-week
Time frame: The assessments will be conducted 1 and 12 weeks following the intervention
Using a custom-made isometric dynamometer to measure the strength of trunk flexors, extensors and rotators
Changes in strength of core muscle groups (hip) at 12-week
Time frame: The assessments will be conducted 1 and 12 weeks following the intervention
Using a hand-held dynamometer to measure the hip muscle strength
Changes in endurance of core muscle groups at 12-week
Time frame: The assessments will be conducted 1 and 12 weeks following the intervention
Using the Stabilizer Pressure Biofeedback Unit (PBU) during the leg-loading test to measure the endurance of lumbo-pelvic stability
Changes in flexibility of the lower back and hamstring muscles at 12-week
Time frame: The assessments will be conducted 1 and 12 weeks following the intervention
Using the sit and reach test to measure the flexibility of the lower back and hamstring muscles
Changes in ability of the dynamic balance at 12-week
Time frame: The assessments will be conducted 1 and 12 weeks following the intervention
Using the Dual-tasking 3m Timed up and go (3m-TUG) to measure dynamic balance and the fall risk. Mean time to perform 3m-TUG is 11.56 seconds
Changes in assessment of postural control at 12-week
Time frame: The assessments will be conducted 1 and 12 weeks following the intervention
Using a force plate to collect the center of pressure (COP) displacement
Changes in muscle activity of selected core muscles during performing arm-raising tasks at 12-week
Time frame: The assessments will be conducted 1 and 12 weeks following the intervention
Using a surface electromyography to record the muscle activity of abdominal and trunk muscles during performing arms-raising tasks with hand-holding 1.5-2 kg
Changes in assessment of postural control during performing arm-raising tasks at 12-week
Time frame: The assessments will be conducted 1 and 12 weeks following the intervention
Using a force plate to collect the center of pressure (COP) displacement during performing arms-raising tasks with hand-holding 1.5-2 kg
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 14 May 2021.
- Individual participant dataSharing planned: No. Currently in the submission stage ,and then share with other researchers after publication
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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.
Li-Jiun Liaw study director
Kaohsiung Medical University Department of Physical Therapy Associate Professor
Questions about this trial
What is this clinical trial studying?
A study testing Core exercise and Tai Chi exercise in people with Tai Ji, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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 6 inclusion and 5 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 14 May 2021. 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. 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?
Changes in strength of core muscle groups (trunk) at 12-week (time frame: The assessments will be conducted 1 and 12 weeks following the intervention). 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?
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 14 May 2021.