Status Approved
First Submitted Date
2020/12/21
Registered Date
2020/12/29
Last Updated Date
2020/12/21
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005716 |
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Unique Protocol ID | 1044396-202011-HR-197-01 |
Public/Brief Title | Effects of a 6 week exercise program on the physical and psychological health in patient with mild demntia. |
Scientific Title | Effects of a 6 Week Complex Exercise Program on the Physical and Psychological health and Quality of Life in Patient with Mild Dementia. |
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 | 1044396-202011-HR-197-01 |
Approval Date | 2020-12-09 |
Institutional Review Board Name | Gachon University Institutional Review Board |
Institutional Review Board Address | 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do |
Institutional Review Board Telephone | 031-750-8566 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Hwiyoung Cho |
Title | Professor |
Telephone | +82-31-750-8566 |
Affiliation | Gachon University |
Address | 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea |
Contact Person for Public Queries | |
Name | SungHyeon Kim |
Title | research worker |
Telephone | +82-31-750-8566 |
Affiliation | Gachon University |
Address | 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea |
Contact Person for Updating Information | |
Name | Hwiyoung Cho |
Title | Professor |
Telephone | +82-31-750-8566 |
Affiliation | Gachon University |
Address | 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-01-04 Anticipated | |
Target Number of Participant | 30 | |
Primary Completion Date | 2021-12-08 , Anticipated | |
Study Completion Date | 2021-12-08 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Gachon University | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-01-04 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Gachon University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Gachon University |
Organization Type | University |
7. Study Summary
Lay Summary | Dementia is a chronic and progressive syndrome of the brain with impairments of several higher cortical functions, including executive function, memory, thinking, and comprehension. Dementia generally manifests itself as forgetfulness at first, but can appear in various forms, leading to limitations in self-management and function performance. It is impossible to return dementia to its previous state, but therapeutic exercise is considered one of the main strategies for preventing dementia, improving symptoms of dementia, and delaying the progression of dementia. In general, exercise is known to improve depression and cognitive function in the elderly. In particular, aerobic exercise program is reported as an effective method for improving cognitive speed and some aspects of cognitive function such as memory and attention. The circuit exercise program is an effective intervention method for improving balance, walking ability, daily life movements, anxiety and depression in neurological patients. However, few studies have been conducted to determine the effectiveness of the circular exercise program in patients with mild dementia. Although aerobic exercise and circulatory exercise have the potential to help improve the physical and mental health and quality of life of patients with hard dementia, so far, there is a lack of reports on the effectiveness of programs that incorporate aerobic exercise and circulatory exercise. The purpose of this study is to investigate the effect of 6 weeks of complex exercise on physical and mental health and quality of life in patients with mild dementia. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Not Applicable |
Intervention Type | Others (complex exercise program) |
Intervention Description | Subjects participate in a complex exercise program consisting of a circuit exercise program and an aerobic exercise program for 6 weeks. Cycling program: warm-up, strength training, balance training. Aerobic exercise program: long distance walking. |
Number of Arms | 1 |
Arm 1 |
Arm Label patient with mild dementia |
Target Number of Participant 30 |
|
Arm Type Experimental |
|
Arm Description Subjects participate in a complex exercise program consisting of a circuit exercise program and an aerobic exercise program for 6 weeks. Cycling program: warm-up, strength training, balance training. Aerobic exercise program: long distance walking. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (F00-F99)Mental and behavioural disorders (F03)Unspecified dementia dementia |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 60Year~No Limit |
|
Description 1) Persons with a score of 24 or less for the Mini Mental State Examination-KOREA (MMSE-K) 2) Persons with no other neurological comorbidities other than mild dementia 3) Persons who do not have other mental illnesses other than mild dementia |
|
Exclusion Criteria |
1) Persons with a history of stroke with movement disorders 2) Persons with a history of traumatic brain injury with movement disorders |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | muscle strength |
|
Timepoint | before exercise program, after the exercise program, 4 weeks after exercise program |
|
Primary Outcome(s) 2 | ||
Outcome | balance ability |
|
Timepoint | before exercise program, after the exercise program, 4 weeks after exercise program |
|
Primary Outcome(s) 3 | ||
Outcome | gait ability |
|
Timepoint | before exercise program, after the exercise program, 4 weeks after exercise program |
|
Secondary Outcome(s) 1 | ||
Outcome | Activity of daily living |
|
Timepoint | before exercise program, after the exercise program, 4 weeks after exercise program |
|
Secondary Outcome(s) 2 | ||
Outcome | quality of life |
|
Timepoint | before exercise program, after the exercise program, 4 weeks after exercise program |
|
Secondary Outcome(s) 3 | ||
Outcome | depression |
|
Timepoint | before exercise program, after the exercise program, 4 weeks after exercise program |
|
Secondary Outcome(s) 4 | ||
Outcome | mental state |
|
Timepoint | before exercise program, after the exercise program, 4 weeks after exercise program |
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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