Investigation of Impacts of Vibration on Muscular Strength and Functional Performance of Upper Limbs of Older Adults
Primary Purpose
Sarcopenia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
vibration machine
Sponsored by

About this trial
This is an interventional prevention trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria:
Sarcopenia of older people
Exclusion Criteria:
- 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
Sites / Locations
- TMU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
control group
Arm Description
the control group will receive regular exercise training at same time.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Assess the improvement of quality of life due to muscle strength improvement
IADL+ Quality of life to understand physical fitness and functional performance of upper limbs between groups after intervention .This sub-questionnaire is based on the subjective feelings of the elderly in the last two weeks, measured by interviews and observation behaviors.
Full Information
NCT ID
NCT04767932
First Posted
November 12, 2020
Last Updated
February 22, 2021
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04767932
Brief Title
Investigation of Impacts of Vibration on Muscular Strength and Functional Performance of Upper Limbs of Older Adults
Official Title
Investigation of Impacts of Vibration on Muscular Strength and Functional Performance of Upper Limbs of Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
April 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Experimental
Arm Description
the control group will receive regular exercise training at same time.
Intervention Type
Behavioral
Intervention Name(s)
vibration machine
Intervention Description
Experimental: vibration intervention the experimental group will perform 20mins/ section, three times weekly for 8 weeks vibration training
Primary Outcome Measure Information:
Title
muscle strength of upper limbs.
Description
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.
Time Frame
15 min
Secondary Outcome Measure Information:
Title
Assess the improvement of quality of life due to muscle strength improvement
Description
IADL+ Quality of life to understand physical fitness and functional performance of upper limbs between groups after intervention .This sub-questionnaire is based on the subjective feelings of the elderly in the last two weeks, measured by interviews and observation behaviors.
Time Frame
20 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Sarcopenia of older people
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chia-hui kao, master
Organizational Affiliation
student
Official's Role
Principal Investigator
Facility Information:
Facility Name
TMU
City
Taipei city
ZIP/Postal Code
110301
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Investigation of Impacts of Vibration on Muscular Strength and Functional Performance of Upper Limbs of Older Adults
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