Flexi-barNCT05688553
The Effects of Using Flexi-bar for Balance and Strength Training on the Balance and Muscle in Community-Dwelling Older Adults
A study testing Flexi-bar and balance and strength training in people with Flexi-bar and Vibration, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Aging of the neuromuscular system may lead to an increased risk of falls in older adults. There are external and internal factors for falls, and lower limb muscle strength and balance are important internal factors for falls in the elderly. And can be improved through exercise. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Flexi-bar, Vibration, Balance Training
- What is being tested?
- Flexi-bar and balance and strength training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Nov 2022to 31 Dec 2025
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- •Elderly people aged 65 to 85 in the community who can move on their own without the need for support from others.
Who cannot join
- Vulnerable groups: those who lack sufficient decision-making ability due to age, intellectual or physical (physiological) status, or who are vulnerable to undue influence, coercion, or inability to make decisions of free will due to their environment, identity, or socioeconomic status, People living in nursing homes and racially disadvantaged groups, etc.
- Have been diagnosed with mental illness and cognitive impairment
- Those who have had severe cardiovascular-related diseases such as unstable angina pectoris, acute myocardial infarction and are not suitable for vigorous exercise
- Those with a history of epilepsy
- Those with severe pain in the lower extremity joints during the pre-test and unable to complete the above-mentioned lower extremity muscle strength or balance test.
Trial locations and contacts
1 site in 1 country.
Kaohsiung Medical University Chung-Ho Memorial Hospital sport medicine contact
Taiwan1 site, 1 recruiting
- Recruiting
Xinqiang Li Activity Center
Kaohsiung City, 830
HSU TZ RUEI, Associate, 0970947604, st990533@gmail.com
About this study
Aging of the neuromuscular system may lead to an increased risk of falls in older adults. There are external and internal factors for falls, and lower limb muscle strength and balance are important internal factors for falls in the elderly. And can be improved through exercise. Therefore, an important interventional goal in interventional exercises to prevent falls in the elderly is to promote balance and increase lower extremity muscle strength.
Flexi-bar is a device that provides vibration stimulation. Studies have shown that a 5Hz frequency can be generated when shaken and transmitted to the whole body. Flexi bar is now widely used in fitness centers or rehabilitation therapy to improve muscle strength and balance. Vibration activates the tonic reflex, enhances the excitability of alpha and gamma motor neurons and enhances motor unit synchronization, and this active vibration training helps increase muscle coordination as it induces the tonic reflex and stimulates the proprioception of the joint Feelings, these physiological changes can lead to more effective proprioceptive feedback that improves balance. And because the vibration causes the agonist and antagonist muscles to contract alternately to regulate the instability during the movement. In recreational athletes, the use of a flexi bar in a single-legged position can effectively induce lower extremity muscle activation.
Read more
A 12-week combination of balance and strength training in older adults has been shown to be effective in reducing the risk of falls in older adults in previous studies.
Since the effect of adding Flexi bar on the basis of balance and strength training is unknown, the purpose of this study was to investigate the experimental group and the control group with the same exercise posture and training time, Flexi bar + BST Is it better for the balance and muscle strength of the elderly than simple BST?
- Conditions
- Flexi-bar, Vibration, Balance Training, Community-dwelling, Community Older, Strength Training
- Being tested
- Flexi-bar, balance and strength training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexi-barDevice
two groups, experimental group intervention Flexi-bar with balance and strength training
balance and strength trainingOther
the control group intervention only balance and strength training
| Study group | Role | What they receive |
|---|---|---|
| Flexi-bar group | Experimental | Not described Receives: Device: Flexi-bar |
| balance and strength group | Active comparator | Not described Receives: Other: balance and strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline gait and balance at 12 weeks
Functional gait assessment
Measured: baseline , up to 12 weeks( post test)
change from baseline dynamic balance at 12 weeks
Y-Balance Test
Measured: baseline , up to 12 weeks( post test)
change from baseline balance at 12 weeks
Mini-Balance Evaluation Systems Test
Measured: baseline , up to 12 weeks( post test)
Secondary outcomes (3)
change from baseline lower strength at 12 weeks (1)
Chair standing test
Measured: baseline , up to 12 weeks( post test)
change from baseline lower strength at 12 weeks(2)
hand held dynamometer
Measured: baseline , up to 12 weeks( post test)
change from baseline ankle plantar flexor strength at 12 weeks
ankle plantar flexion test
Measured: baseline , up to 12 weeks( post test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start7 Nov 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexi-barStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688553
- Sponsor's protocol ID
- KMUHIRB-E(I)-20220165
- Status last verified
- Nov 2022
- First submitted
- 23 Sep 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using Flexi-bar for Balance and Strength Training on the Balance and Muscle in Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT05688553
- Acronym / sponsor ID
- KMUHIRB-E(I)-20220165
- Conditions
- Flexi-bar, Vibration, Balance Training, Community-dwelling, Community Older, Strength Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jan 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.
Aging of the neuromuscular system may lead to an increased risk of falls in older adults. There are external and internal factors for falls, and lower limb muscle strength and balance are important internal factors for falls in the elderly. And can be improved through exercise. Therefore, an important interventional goal in interventional exercises to prevent falls in the elderly is to promote balance and increase lower extremity muscle strength.
Flexi-bar is a device that provides vibration stimulation. Studies have shown that a 5Hz frequency can be generated when shaken and transmitted to the whole body. Flexi bar is now widely used in fitness centers or rehabilitation therapy to improve muscle strength and balance. Vibration activates the tonic reflex, enhances the excitability of alpha and gamma motor neurons and enhances motor unit synchronization, and this active vibration training helps increase muscle coordination as it induces the tonic reflex and stimulates the proprioception of the joint Feelings, these physiological changes can lead to more effective proprioceptive feedback that improves balance. And because the vibration causes the agonist and antagonist muscles to contract alternately to regulate the instability during the movement. In recreational athletes, the use of a flexi bar in a single-legged position can effectively induce lower extremity muscle activation.
A 12-week combination of balance and strength training in older adults has been shown to be effective in reducing the risk of falls in older adults in previous studies.
Since the effect of adding Flexi bar on the basis of balance and strength training is unknown, the purpose of this study was to investigate the experimental group and the control group with the same exercise posture and training time, Flexi bar + BST Is it better for the balance and muscle strength of the elderly than simple BST?
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexi-bar group | Experimental | Device: Flexi-bar |
| balance and strength group | Active comparator | Other: balance and strength training |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- •Elderly people aged 65 to 85 in the community who can move on their own without the need for support from others.
Key exclusion criteria (5 listed)
- Vulnerable groups: those who lack sufficient decision-making ability due to age, intellectual or physical (physiological) status, or who are vulnerable to undue influence, coercion, or inability to make decisions of free will due to their environment, identity, or socioeconomic status, People living in nursing homes and racially disadvantaged groups, etc.
- Have been diagnosed with mental illness and cognitive impairment
- Those who have had severe cardiovascular-related diseases such as unstable angina pectoris, acute myocardial infarction and are not suitable for vigorous exercise
- Those with a history of epilepsy
- Those with severe pain in the lower extremity joints during the pre-test and unable to complete the above-mentioned lower extremity muscle strength or balance test.
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 |
|---|---|---|
| Flexi-bartwo groups, experimental group intervention Flexi-bar with balance and strength training | Device | Flexi-bar group |
| balance and strength trainingthe control group intervention only balance and strength training | Other | balance and strength group |
Primary outcome
change from baseline gait and balance at 12 weeks
Time frame: baseline , up to 12 weeks( post test)
Functional gait assessment
change from baseline dynamic balance at 12 weeks
Time frame: baseline , up to 12 weeks( post test)
Y-Balance Test
change from baseline balance at 12 weeks
Time frame: baseline , up to 12 weeks( post test)
Mini-Balance Evaluation Systems Test
3 secondary outcomes
change from baseline lower strength at 12 weeks (1)
Time frame: baseline , up to 12 weeks( post test)
change from baseline lower strength at 12 weeks(2)
Time frame: baseline , up to 12 weeks( post test)
change from baseline ankle plantar flexor strength at 12 weeks
Time frame: baseline , up to 12 weeks( post test)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
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Acute Effects of Exercise Bars on Proprioception, ReactionTime, Power and Upper Extremity Performance
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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.
Kaohsiung Medical University Chung-Ho Memorial Hospital sport medicine contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexi-bar and balance and strength training in people with Flexi-bar and Vibration, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 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: status not confirmed, as of the sponsor's last update on 18 Jan 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 Taiwan. 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 HSU TZ RUEI, Associate (0970947904, st990533@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline gait and balance at 12 weeks (time frame: baseline , up to 12 weeks( post test)). The study lists 3 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 18 Jan 2023.