UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013199 |
|---|---|
| Receipt number | R000015391 |
| Scientific Title | A randomized controlled trial of non-pharmacological interventions (cognitive training, physical activities, reminiscence) for old-old people with mild cognitive impairment (MCI) |
| Date of disclosure of the study information | 2014/02/19 |
| Last modified on | 2014/02/19 10:35:06 |
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Basic information
Public title
A randomized controlled trial of non-pharmacological interventions (cognitive training, physical activities, reminiscence) for old-old people with mild cognitive impairment (MCI)
Acronym
A randomized controlled trial of non-pharmacological interventions (cognitive training, physical activities, reminiscence) for old-old people with mild cognitive impairment (MCI)
Scientific Title
A randomized controlled trial of non-pharmacological interventions (cognitive training, physical activities, reminiscence) for old-old people with mild cognitive impairment (MCI)
Scientific Title:Acronym
A randomized controlled trial of non-pharmacological interventions (cognitive training, physical activities, reminiscence) for old-old people with mild cognitive impairment (MCI)
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of cognitive training, physical activities, and reminiscence for cognitive functions in old-old people with mild cognitive impairment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mini-Mental State Examination (MMSE), Trail Making Test part A (TMT-A), 6-meter walking time, and QOL-Face Scale
Key secondary outcomes
impression
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive training
Interventions/Control_2
Physical activities
Interventions/Control_3
Reminiscence
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Mild Cognitive Impairment
Clinical Dementia Rating 0.5
Key exclusion criteria
1) A medical history of stroke or neurological signs such as hemiparesis.
2) A medical history of orthopedic disease or heart disease.
3) People who lived alone were also excluded from the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Meguro |
Organization
Tohoku University
Division name
CYRIC
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, 980-8575 Sendai, Japan
TEL
022-717-7359
k-meg@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Meguro |
Organization
Tohoku University
Division name
CYRIC
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, 980-8575 Sendai, Japan
TEL
022-717-7359
Homepage URL
k-meg@umin.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Kurihara Cit
Organization
Division
Category of Funding Organization
Local Government
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
| 2014 | Year | 02 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
All interventions (cognitive training, physical activities, and reminiscence) improved QOL and executive functions. Especially, cognitive training and physical activities improved MMSE and 6-m walking speed, respectively.
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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 19 | Day |
Last modified on
| 2014 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015391
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
