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
CRIS Registration Number |
KCT0004619 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | National Research Foundation |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Ajou University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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 |
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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
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 |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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