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The effect of resistance exercise program applied to the elderly on pain, depression, autonomic nervous system balance, stress, range of motion, and body composition

Status Approved

  • First Submitted Date

    2020/05/27

  • Registered Date

    2020/05/28

  • Last Updated Date

    2020/05/28

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005066
    Unique Protocol ID EU19-75
    Public/Brief Title The effect of resistance exercise program applied to the elderly on pain, depression, autonomic nervous system balance, stress, range of motion, and body composition
    Scientific Title The effect of resistance exercise program applied to the elderly on pain, depression, autonomic nervous system balance, stress, range of motion, and body composition
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number EU19-75
    Approval Date 2019-09-18
    Institutional Review Board Name Institutional Review Board of EULJI University
    Institutional Review Board Address 77, Gyeryong-ro 771beon-gil, Jung-gu, Daejeon
    Institutional Review Board Telephone 042-259-1691
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Kim Won Jong
    Title assistant professor
    Telephone +82-42-259-1716
    Affiliation Eulji University
    Address 34824) Daejeon, Jung-gu, Gyeryong-ro 771beon-gil, 90, Republic of Korea
    Contact Person for Public Queries
    Name Kim Won Jong
    Title assistant professor
    Telephone +82-42-259-1716
    Affiliation Eulji University
    Address 34824) Daejeon, Jung-gu, Gyeryong-ro 771beon-gil, 90, Republic of Korea
    Contact Person for Updating Information
    Name Kim Won Jong
    Title assistant professor
    Telephone +82-42-259-1716
    Affiliation Eulji University
    Address 34824) Daejeon, Jung-gu, Gyeryong-ro 771beon-gil, 90, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Active, not recruiting
    Date of First Enrollment 2019-09-18 Actual
    Target Number of Participant 80
    Primary Completion Date 2019-11-30 , Actual
    Study Completion Date 2020-06-30 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Gimcheon Health Center
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2019-09-18 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name National Research Foundation
    Organization Type Others
    Project ID 2018045374
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Eulji University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Purpose : This study applies a 12-week resistance exercise program using elastic bands to the elderly. This is an experimental study to understand the effects on pain, depression, autonomic nervous system balance, stress, range of motion, and body composition through resistance exercise.
    
    background : In 2019, the proportion of the population aged 65 and over in Korea was 14.6%, and is expected to increase to 40% by 2060. The aging affects the overall aspect of the human body and leads to a decrease in strength, flexibility and agility. In addition, the musculoskeletal system easily causes fatigue and increases the pain and stress caused by the accumulation of fatigue, thereby limiting the movement of normal joints. Therefore, they are limited in their activities and are accompanied by movement disorders, pain, depression, and poor quality of life during daily life. In particular, 94% of the elderly have muscle and bone problems, and 49.6% experience musculoskeletal disorders. A typical biological change according to aging is a change in body composition, that is, the proportion of body fat in body weight increases, but skeletal muscle mass is reduced among lean body masses. Muscles decrease by about 8% every 10 years from the 40s, and when they reach their 70s, the rate of decrease increases to 15% over the 10 years. As a result of this, non-active activities have further promoted the phenomenon of aging, reduced the ability to fight various diseases, and mental problems due to stress reactions such as depression and cognitive impairment. In terms of mental health, the elderly seem to be experiencing severe stress levels, and in the case of the elderly, the stress response phenomenon cannot be avoided. The response of stress activates the sympathetic nervous system and decreases the activity of the parasympathetic nervous system. In addition, it is reported that it exists before cardiovascular disease is developed as a risk factor affecting the heart rate control of autonomic nerves. Through these results, efforts should be made to eliminate risk factors before the imbalance of autonomic nerves appears. Therefore, the resistance exercise using the elastic band developed by this researcher is applied to the elderly for 12 weeks to verify the effect of the subject in terms of pain and depression, stress, range of motion, and fat mass and muscle mass. 
    
    Research hypothesis : 
    1) Hypothesis 1: There are differences in shoulder pain between experimental group using resistance exercise program and control group. 
    2) Hypothesis 2: There are a difference in the depression between the experimental group using the resistance exercise program and the control group.
    3) Hypothesis 3: There are a differences in the stress between the experimental group using the resistance exercise program and the control group.
    4) Hypothesis 4: The range of motion of the left and right shoulder joints in the experimental group applied resistance exercise program and the control group are different. 
    5) Hypothesis 5: The body composition(muscle, fat thickness) of left and right shoulder joints in the experimental group applied resistance exercise program and the control group are different. 
    
    Plan: The subjects of the study will be 40 subjects in the experimental group and 40 subjects in the control group. The experimental group will conduct a resistance exercise program at the G-city public health center for three days a week for 12 weeks from 10 am to 12 pm. The control group is a group that did not participate in the resistance exercise program and intends to continue their normal daily life for 12 weeks. The measurement will be conducted to the experimental group and the control group three times before the experimental treatment (0 week), 6 weeks, and 12 weeks.The experimental group and the control group will select different days of the week to measure pain, depression, autonomic nervous system balance, stress, range of motion, and body composition.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Basic Science
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Medical Device  
    Intervention Description
    Exercise group: Resistance exercise program using Thera-band for 8 weeks 
    Control group: Daily life without intervention
    Number of Arms 2
    Arm 1

    Arm Label

    Exercise group

    Target Number of Participant

    40

    Arm Type

    Experimental

    Arm Description

    Intervention equipment: Thera-band 
    Intervention type: Resistance exercise 
    Intervention action: Consisting of 8 actions 
    (including internal rotation, external rotation, adduction, abduction, flexion, extension) 
    Frequency of intervention: Monday, Wednesday and Friday of the week, total 8 weeks 
    Time required for 1 trip Intervention: The time it takes to perform a total of 8 movements once(takes about 8m 30sec) 
    Total time required for Intervention: The time of the day's resistance program(About 70 minutes/day)
    Arm 2

    Arm Label

    Control group

    Target Number of Participant

    40

    Arm Type

    No intervention

    Arm Description

    The control group is a group that did not participate in the resistance exercise program and intends to continue their normal daily life for 12 weeks.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s)    Not Applicable-Quality of life 

    Diseases of the muscular system and connective tissue Elderly/pain/Body Composition
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    60Year~80Year

    Description

    ① Those who understand and agree with the purpose of the research. 
    ② Middle-aged women from 60 to 80 years of age 
    ③ Those who are in a state of consciousness and able to communicate
    Exclusion Criteria
    ① Those who had surgery on the scapula region 
    ② Person with severe pain at rest 
    ③ The person who has a structural problem(dislocations, deformities, fractures, etc.) 
    ④ Those who have limitation of joint movement by 60 degrees of flexion, 60 degrees of abduction, 20 degrees of external rotation, and 30 degrees of internal rotation (less than 1/3 of normal range) 
    ⑤ Those who have been diagnosed with shoulder disease such as rheumatism, osteoporosis, bursitis 
    ⑥ Those who taken shoulder related medicine such as antibiotics, analgesics, steroid medicine, etc
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Shoulder Pain
    Timepoint
    Pre-test: Before the experiment, Post-test: 6th week, 12th week
    Primary Outcome(s) 2
    Outcome
    Shoulder ROM(Range Of Motion)
    Timepoint
    Pre-test: Before the experiment, Post-test: 6th week, 12th week
    Primary Outcome(s) 3
    Outcome
    Body composition around shoulder joint
    Timepoint
    Pre-test: Before the experiment, Post-test: 6th week, 12th week
    Secondary Outcome(s) 1
    Outcome
    stress
    Timepoint
    Pre-test: Before the experiment, Post-test: 6th week, 12th week
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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