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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05688553
Other study ID # KMUHIRB-E(I)-20220165
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 7, 2022
Est. completion date December 31, 2025

Study information

Verified date November 2022
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact HSU TZ RUEI, Associate
Phone 0970947904
Email st990533@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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?


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Flexi-bar
two groups, experimental group intervention Flexi-bar with balance and strength training
Other:
balance and strength training
the control group intervention only balance and strength training

Locations

Country Name City State
Taiwan Xinqiang Li Activity Center Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary change from baseline gait and balance at 12 weeks Functional gait assessment baseline , up to 12 weeks( post test)
Primary change from baseline dynamic balance at 12 weeks Y-Balance Test baseline , up to 12 weeks( post test)
Primary change from baseline balance at 12 weeks Mini-Balance Evaluation Systems Test baseline , up to 12 weeks( post test)
Secondary change from baseline lower strength at 12 weeks (1) Chair standing test baseline , up to 12 weeks( post test)
Secondary change from baseline lower strength at 12 weeks(2) hand held dynamometer baseline , up to 12 weeks( post test)
Secondary change from baseline ankle plantar flexor strength at 12 weeks ankle plantar flexion test baseline , up to 12 weeks( post test)
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