UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018933 |
|---|---|
| Receipt number | R000021903 |
| Scientific Title | Effect and feasibility of an exercise program for the prevention of cognitive decline and dementia |
| Date of disclosure of the study information | 2016/01/20 |
| Last modified on | 2016/01/20 13:45:28 |
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Basic information
Public title
Effect and feasibility of an exercise program for the prevention of cognitive decline and dementia
Acronym
Exercise and cognition
Scientific Title
Effect and feasibility of an exercise program for the prevention of cognitive decline and dementia
Scientific Title:Acronym
Exercise and cognition
Region
| Asia(except Japan) |
Condition
Condition
On going study
Classification by specialty
| Medicine in general | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this study was to examined the Effect and feasibility of an exercise program for the prevention of cognitive decline and dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Combined exercise improve to cognitive function in patients with mild cognitive impairment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
3 time/week for 12 weeks combined exercise/
Interventions/Control_2
control group - free-living activity
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients and caregivers should appeal to a loss of memory.
2. No significant activity of daily activity
3. dementia should not be at the discretion of the clinician.
4. Patients who can read and write text
5. Age 50-85 years old
6. Regular (Note 3 times ) no exercise habits.
7. Patients participating in the study must agree in writing.
Key exclusion criteria
1. Rated for clinical trials about treatment, participate in another clinical trial within the last 4 weeks.
2. Unstable physical evidence of the disease
3. In the past year received a diagnosis of major depression.
4. Patients with a finding that could lead to effects on cognitive function in clinical pathology
5. within the last 10 years drug addiction or alcoholism in patients with a history.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kwon Won Park |
Organization
Dong-A University
Division name
College of Medicine
Zip code
Address
32, Daeshingongwon-Ro, Seo-Gu, Busan, 602-715 Rep. of Korea
TEL
82-51-240-2763
jpark@dau.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jong-Hwan Park |
Organization
Dong-A University
Division name
The Dong-A Anti-aging Research Institute
Zip code
Address
32, Daeshingongwon-Ro, Seo-Gu, Busan, 602-715
TEL
+82-51-240-2763
Homepage URL
jpark@dau.ac.kr
Sponsor or person
Institute
Dong-A University
Institute
Department
Personal name
Funding Source
Organization
Dong-A Univeristy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 07 | Day |
Last modified on
| 2016 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021903
