- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05688553
The Effects of Using Flexi-bar for Balance and Strength Training on the Balance and Muscle in Community-Dwelling Older Adults
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: HSU TZ RUEI, Associate
- Phone Number: 0970947904
- Email: st990533@gmail.com
Study Contact Backup
- Name: Kaohsiung Medical University Chung-Ho Memorial Hospital sport medicine
- Phone Number: 6643.6644 (07) 312-1101
Study Locations
-
-
-
Kaohsiung, Taiwan, 830
- Recruiting
- Xinqiang Li Activity Center
-
Contact:
- HSU TZ RUEI, Associate
- Phone Number: 0970947604
- Email: st990533@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
•Elderly people aged 65 to 85 in the community who can move on their own without the need for support from others.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Flexi-bar group
|
two groups, experimental group intervention Flexi-bar with balance and strength training
|
Active Comparator: balance and strength group
|
the control group intervention only balance and strength training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change from baseline gait and balance at 12 weeks
Time Frame: baseline , up to 12 weeks( post test)
|
Functional gait assessment
|
baseline , up to 12 weeks( post test)
|
change from baseline dynamic balance at 12 weeks
Time Frame: baseline , up to 12 weeks( post test)
|
Y-Balance Test
|
baseline , up to 12 weeks( post test)
|
change from baseline balance at 12 weeks
Time Frame: baseline , up to 12 weeks( post test)
|
Mini-Balance Evaluation Systems Test
|
baseline , up to 12 weeks( post test)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change from baseline lower strength at 12 weeks (1)
Time Frame: baseline , up to 12 weeks( post test)
|
Chair standing test
|
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)
|
hand held dynamometer
|
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)
|
ankle plantar flexion test
|
baseline , up to 12 weeks( post test)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KMUHIRB-E(I)-20220165
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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