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Effects of a 6 Week Complex Exercise Program on the Physical and Psychological health and Quality of Life in Patient with Mild Dementia.

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

    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
    KCT0005716
    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

    Institutional Review Board Information
    Board Approval Status Submitted approval
    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 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 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

    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 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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Gachon University
    Organization Type University
    Project ID
  • 6. Sponsor Organization

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

    Study Summary Information
    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.
  • 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
    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

    Subject Eligibility Information
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F03)Unspecified dementia 

    dementia
    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)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    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

    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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