UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006998 |
|---|---|
| Receipt number | R000008259 |
| Scientific Title | The beneficial effect of reading aloud and simple calculations intervention on a widely cognitive function in the healthy elderly |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2015/12/05 11:13:21 |
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Basic information
Public title
The beneficial effect of reading aloud and simple calculations intervention on a widely cognitive function in the healthy elderly
Acronym
The beneficial effect of reading aloud and simple calculations in the elderly
Scientific Title
The beneficial effect of reading aloud and simple calculations intervention on a widely cognitive function in the healthy elderly
Scientific Title:Acronym
The beneficial effect of reading aloud and simple calculations in the elderly
Region
| Japan |
Condition
Condition
The healthy elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the beneficial effects of reading aloud and simple calculation on the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stroop Test (ST)
Key secondary outcomes
Verbal fluency task (VFT)
Logical Memory (LM)
First and Second Names (FS-N)
Digit Span Forward (DS-F)
Digit span Backward (DS-B)
Japanese Reading Test (JART)
Digit Cancellation Task (D-CAT)
Digit Symbol Coding (Cd)
Symbol Search (SS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The cognitive intervention group participate in reading aloud and simple calculation intervention in 6 months
Interventions/Control_2
The wait listed group does not participate in the intervention.
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We include participants who will report to be right-handed, native Japanese speakers, not concerned about their own memory functions, not using medications known to interfere with cognitive functions (including benzodiazepines, antidepressants or other central nervous agents), and having no diseases known to affect the central nervous system, including thyroid disease, multiple sclerosis, Parkinson's disease, stroke, severe hypertension or diabetes.
Key exclusion criteria
We exclude participants who will have IQ less than 85 derived from JART. Participants who will participate in another cognitive-related training.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rui Nouchi |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Smart Aging International Research Center
Zip code
Address
Seiryo-machi 4-1, Aoba-ku Sendai
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Smart Aging International Research Center
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 01 | Month | 01 | 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
| 2011 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | 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
| 2012 | Year | 01 | Month | 01 | Day |
Last modified on
| 2015 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008259
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
