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
CRIS Registration Number |
KCT0005066 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | National Research Foundation |
Organization Type | Others |
Project ID | 2018045374 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Eulji University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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 |
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Arm Type Experimental |
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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 |
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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
Condition(s)/Problem(s) |
Not Applicable-Quality of life
Diseases of the muscular system and connective tissue Elderly/pain/Body Composition |
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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)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Shoulder Pain |
|
Timepoint | Pre-test: Before the experiment, Post-test: 6th week, 12th week |
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Primary Outcome(s) 2 | ||
Outcome | Shoulder ROM(Range Of Motion) |
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Timepoint | Pre-test: Before the experiment, Post-test: 6th week, 12th week |
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Primary Outcome(s) 3 | ||
Outcome | Body composition around shoulder joint |
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Timepoint | Pre-test: Before the experiment, Post-test: 6th week, 12th week |
|
Secondary Outcome(s) 1 | ||
Outcome | stress |
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Timepoint | Pre-test: Before the experiment, Post-test: 6th week, 12th week |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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