NCT04767932

Brief Summary

The elderly population is increasing at worldwide. The need of health promotion and maintenance for elderly adults has become a critical issue. According to a national investigation in 2017, the number of people over 65 years old accounts for 13.33% of the total population and would reach 20.1% by 2050. Muscle strength and functional performances of upper limbs play an important role in most daily activities in elderly adults. However, with aging, the muscle strength of upper extremities could be affected and decrease the functional performances of daily living. Vibration exercise can be used to induce the muscle contraction and motor control in lower limbs for people with neuromuscular disorders. Few studies have investigated the training effects on muscle strength and functional performances of upper limbs for elderly adults。Therefore, appropriate training devices and exercise programs to facilitate the muscle strength and functional performances of upper limbs in elderly people would be needed for clinical therapists. Therefore, the purpose of this study was to develop a vibration training device and investigate the training effects on muscle strength and functional performances of upper limbs in elderly people. This study will recruit 44 elderly adults, evaluating the muscle strength and functional performances of upper limbs before and after interventions. All subjects will be randomized assign to experimental and control groups; the experimental group will perform 30mins/ section, three times weekly for 8 weeks vibration training, and the control group will receive regular exercise training at same time. Two-way ANOVA with repeated measure will be applied to analyze the training effects and difference in the muscle strength and functional performances of upper limbs between two groups. SPSS version 18.0 statistical software will be used. The α level for statistical significance is set at 0.05.

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
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 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

Study Start

First participant enrolled

October 26, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2021

Completed
Last Updated

February 23, 2021

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

November 12, 2020

Last Update Submit

February 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • muscle strength of upper limbs.

    use MicroFET3 to understand physical fitness of upper limbs between groups after intervention .The tool for assessing upper limb muscle strength is a tool with good reliability and validity. It includes wrist flexor, extensor, brachioradialis, biceps, triceps, and deltoid muscle strength performance. The researcher places the muscle to be measured and asks the subject to hold the dynamometer for three to five seconds, measure twice, record in kilograms to one decimal place, and measure twice in total. The higher value is recorded in kilograms to the next decimal place.

    15 min

Secondary Outcomes (1)

  • Assess the improvement of quality of life due to muscle strength improvement

    20 min

Study Arms (1)

control group

EXPERIMENTAL

the control group will receive regular exercise training at same time.

Behavioral: vibration machine

Interventions

Experimental: vibration intervention the experimental group will perform 20mins/ section, three times weekly for 8 weeks vibration training

control group

Eligibility Criteria

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

You may qualify if:

  • Sarcopenia of older people

You may not qualify if:

  • Upper limbs acute or chronic nerve, musculoskeletal injury within 6 months
  • Upper extremity surgery in 6 months
  • without a pacemaker
  • without severe vision or hearing problems
  • without severe heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TMU

Taipei, 110301, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • chia-hui kao, master

    student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

February 23, 2021

Study Start

October 26, 2020

Primary Completion

January 31, 2021

Study Completion

April 28, 2021

Last Updated

February 23, 2021

Record last verified: 2020-10

Locations