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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04767932
Other study ID # N201907023
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 26, 2020
Est. completion date April 28, 2021

Study information

Verified date October 2020
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 44
Est. completion date April 28, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility Inclusion Criteria: Sarcopenia of older people Exclusion Criteria: 1. Upper limbs acute or chronic nerve, musculoskeletal injury within 6 months 2. Upper extremity surgery in 6 months 3. without a pacemaker 4. without severe vision or hearing problems 5. without severe heart disease

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan TMU Taipei city

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 20 min
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