UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051124 |
|---|---|
| Receipt number | R000058252 |
| Scientific Title | Study on the effectiveness of a system to maintain and improve convertible attention and frontal lobe function in older adults |
| Date of disclosure of the study information | 2023/06/22 |
| Last modified on | 2023/06/22 11:43:55 |
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Basic information
Public title
Study on the effectiveness of a system to maintain and improve convertible attention and frontal lobe function in older adults
Acronym
Study on the effectiveness of a system to maintain and improve convertible attention and frontal lobe function in older adults
Scientific Title
Study on the effectiveness of a system to maintain and improve convertible attention and frontal lobe function in older adults
Scientific Title:Acronym
Study on the effectiveness of a system to maintain and improve convertible attention and frontal lobe function in older adults
Region
| Japan |
Condition
Condition
Older adults attending rehabilitation facilities
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of lower limb ergometer exercise plus training to maintain and improve conversion attention and frontal lobe function in older adults attending rehabilitation facilities.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in TMT-B time at baseline and completion of intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Lower limb ergometer exercise plus training group to maintain and improve convertible attention and frontal lobe function
Interventions/Control_2
Lower extremity ergometer exercise training group
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
1) Persons who are attending a rehabilitation facility and whose age is between 65 and 85 years old.
2) Persons who are capable of exercising with a lower limb ergometer.
3) Persons who can obtain written consent for participation in this study from the persons themselves.
Key exclusion criteria
1) Mini-Mental State Examination (MMSE) score less than 24 points.
2) Persons with cardiovascular disease requiring medical risk management.
3) Persons with orthopedic disease or pain in the upper or lower limbs.
4) Persons who are deemed inappropriate to conduct this study by the principal investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Okamura |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5450
hokamura@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Okamura |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5450
Homepage URL
hokamura@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Hitoshi Okamura
Funding Source
Organization
Mazda Motor Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sogo Rehabilitation Institute, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.ac.jp
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
| 2023 | Year | 06 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 22 | Day |
Last modified on
| 2023 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058252
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
