NCT05688553

Brief 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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 18, 2023

Status Verified

November 1, 2022

Enrollment Period

3.2 years

First QC Date

September 23, 2022

Last Update Submit

January 15, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • change from baseline gait and balance at 12 weeks

    Functional gait assessment

    baseline , up to 12 weeks( post test)

  • change from baseline dynamic balance at 12 weeks

    Y-Balance Test

    baseline , up to 12 weeks( post test)

  • change from baseline balance at 12 weeks

    Mini-Balance Evaluation Systems Test

    baseline , up to 12 weeks( post test)

Secondary Outcomes (3)

  • change from baseline lower strength at 12 weeks (1)

    baseline , up to 12 weeks( post test)

  • change from baseline lower strength at 12 weeks(2)

    baseline , up to 12 weeks( post test)

  • change from baseline ankle plantar flexor strength at 12 weeks

    baseline , up to 12 weeks( post test)

Study Arms (2)

Flexi-bar group

EXPERIMENTAL
Device: Flexi-bar

balance and strength group

ACTIVE COMPARATOR
Other: balance and strength training

Interventions

Flexi-barDEVICE

two groups, experimental group intervention Flexi-bar with balance and strength training

Flexi-bar group

the control group intervention only balance and strength training

balance and strength group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elderly people aged 65 to 85 in the community who can move on their own without the need for support from others.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinqiang Li Activity Center

Kaohsiung City, 830, Taiwan

RECRUITING

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

HSU TZ RUEI, Associate

CONTACT

Kaohsiung Medical University Chung-Ho Memorial Hospital sport medicine

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

January 18, 2023

Study Start

November 7, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 18, 2023

Record last verified: 2022-11

Locations