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Effect of a 20-week multicomponent and structured exercise intervention on cognitive function in patients with mild cognitive impairment

Status Approved

  • First Submitted Date

    2020/01/03

  • Registered Date

    2020/01/09

  • Last Updated Date

    2020/01/10

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
    KCT0004619
    Unique Protocol ID AJIRB-BMR-SUR-19-254
    Public/Brief Title Effect of the structured exercise intervention for dementia prevention on cognitive function in patients with mild cognitive impairment
    Scientific Title Effect of a 20-week multicomponent and structured exercise intervention on cognitive function in patients with mild cognitive impairment
    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 AJIRB-BMR-SUR-19-254
    Approval Date 2019-12-23
    Institutional Review Board Name Ajou University Hospital Institutional Review Board
    Institutional Review Board Address 164, World cup-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do
    Institutional Review Board Telephone 031-219-5569
    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 So Young Moon
    Title Professor
    Telephone +82-31-219-5175
    Affiliation Ajou University Hospital
    Address 164, Worldcup-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea
    Contact Person for Public Queries
    Name Kyunghwa Sun
    Title Research nurse
    Telephone +82-31-219-5658
    Affiliation Ajou University Hospital
    Address 164, Worldcup-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea
    Contact Person for Updating Information
    Name Sun Min Lee
    Title Clinical fellow
    Telephone +82-31-219-5175
    Affiliation Ajou University
    Address 164, Worldcup-ro, Yeongtong-gu, Suwon-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 2020-01-20 Anticipated
    Target Number of Participant 52
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Ajou University
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-20 ,
  • 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
  • 6. Sponsor Organization

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

    Study Summary Information
    Lay Summary
    The social burden regarding dementia patients is increasing due to the aging society, but the development of drugs for treatment and prevention of dementia has been worse than expected. In particular, there are drugs for cure of mild cognitive impairment which is an intermediate stage between dementia and the normal cognition. In this situation, non-pharmaceutical methods of lifestyle improvement through exercise, nutrition, cognitive intervention, and vascular risk factor management have emerged as preventive measures for dementia, and large-scale interventional studies in Finland have proven effective. Among them, regular exercise has provided the strongest evidence in the prevention of dementia, and the mild cognitive impairment guidelines published recently in the American Academy of Neurology suggest that exercise if based on a higher level than other treatments, including medication. 
    
    The effects of exercise to prevent cognitive decline have been known, but the standards for the type, frequency, and intensity of exercise to see the effect have not been proposed. This research team developed a multi-domain, structured dementia prevention exercise program, and performed a 12-week prior study in patients with pre-dementia to confirm high compliance and safety.
    
    The purpose of this study is to evaluate the effectiveness of the developed exercise program in patients with mild cognitive impairment and to show that multi-domain, structured dementia prevention exercise program is effective in preventing cognitive decline.
  • 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
    Prevention
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Others  
    Intervention Description
    The non-intervention group will perform the regular walking exercise and will implement the structured multi-domain exercise intervention program in the intervention group. Both groups are 20 weeks long, with 50 minutes of an exercise session, 3 times a week, and the intervention program consists of aerobic, strength, balance and flexibility exercises.
    Number of Arms 2
    Arm 1

    Arm Label

    Exercise intervention group

    Target Number of Participant

    26

    Arm Type

    Experimental

    Arm Description

    The exercise intervention group is divided into 2 groups of 13 participants with a trainer respectively. The exercise intervention program consists of aerobic, strength, balance and flexibility exercises for 50 minutes, 3 times a week for 20 weeks using the number mats, elastic bands and chairs.
    Arm 2

    Arm Label

    walking exercise group

    Target Number of Participant

    26

    Arm Type

    Active comparator

    Arm Description

    The walking exercise group is also divided into 2 groups of 13 participants and performs the walking exercise at the usual walking speed.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F06.7)Mild cognitive disorder 

    Patients with mild cognitive impairment who are 60 years of age or older as of the date of study consent
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    60Year~No Limit

    Description

    1. One or more of the following dementia risk factors:
      1) Hypertension on medication
      2) Diabetes mellitus on oral hypoglycemic agent or insulin
      3) Dyslipidemia on medication
      4) Obesity: BMI 25kg/m2 and above
      5) Smoking: patients who have smoked at least 100 cigarettes in their lifetime and smoked more than 1 cigarette in the last month
      6) Excessive drinking: more than 170 grams of alcohol per week
      7) An educational background of less than 9 years
      8) Aerobic exercise with moderate strength (3~6 METS) less than 150 minutes per week (more than 30 minutes, more than 5 days a weak) or high-intensity aerobic exercise (>6METS) less than 60 minutes per week (20 minutes or more, 3 days or more per week)
      9) Insufficient strength exercise; do not perform 8 to 10 muscle group exercises for 10 to 15 repetitions per every exercise session for 2 days or more per week
    
    2. No significant daily life dysfunction: KIADL 0.42 or below
    3. The participant should not be dementia in the judgement of clinicians.
    4. Literacy
    5. Written consent to participate in the research
    Exclusion Criteria
    1. Mental illness such as major depression disorder
    2. Dementia
    3. Other neurodegenerative diseases such as Parkinson's disease
    4. MMSE z-score -1.5 or less
    5. Malignant tumors within 5 years of not being cured
    6. Revascularization or stent insertion within 1 year
    7. Severe or unstable symptomatic cardiovascular disease
    8. Any other evidence of serious or unstable physical condition (acute or severe asthma, active gastrointestinal ulcer, severe liver disease or kidney disease enough to receive dialysis), patients with other medical conditions that may interfere with the completion of the clinical trial
    9. Severe vision loss, severe hearing loss, or communication impairment beyond which intervention and validation cannot be performed
    10. Illiteracy
    11. In case it is deemed difficult to participate in the research in cooperation with the researchers' judgment to the end
    12. In case of difficulty in safely participating in arbitration programs in the judgment of the researchers
    13. Participation in other intervention studies
    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 Efficacy
    Primary Outcome(s) 1
    Outcome
    physical activity (muscle strength, balance, flexibility, cardiopulmonary endurance, cooperation)
    Timepoint
    Before and after the 20-week exercise program, 10th week of the exercise program
    Primary Outcome(s) 2
    Outcome
    Neuropsychological test for cognitive evaluation
    Timepoint
    Before and after the 20-week exercise program
    Primary Outcome(s) 3
    Outcome
    brain imaging (brain MRI for evaluating cortical thickness and activated brain area)
    Timepoint
    Before and after the 20-week exercise program
    Primary Outcome(s) 4
    Outcome
    Electroencephalogram
    Timepoint
    Before and after the 20-week exercise program
    Primary Outcome(s) 5
    Outcome
    Blood biomarker (BDNF, anandamide, 2-arachidonoylglycerol)
    Timepoint
    Exercise program start date, a 10-week workout day, a 20-week workout day
    Secondary Outcome(s) 1
    Outcome
    Emotional state (depression, anger proneness)
    Timepoint
    Before and after the 20-week exercise program, 10th week of the 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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