UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016907 |
|---|---|
| Receipt number | R000019622 |
| Scientific Title | Exercise performance test as a screening tool for mild cognitive impairment in older adults and its outreach |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2019/05/15 09:54:26 |
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Basic information
Public title
Exercise performance test as a screening tool for mild cognitive impairment in older adults and its outreach
Acronym
Exercise performance test as a screening tool for mild cognitive impairment in older adults and its outreach
Scientific Title
Exercise performance test as a screening tool for mild cognitive impairment in older adults and its outreach
Scientific Title:Acronym
Exercise performance test as a screening tool for mild cognitive impairment in older adults and its outreach
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine a relationship between exercise performance test and cognitive level and to develop as a screening tool for mild cognitive impairment (MCI).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Performance on exercise test (Square-Stepping Exercise: SSE) and cognitive function (MoCA)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy and aged 65 years or older
Able to come to a measurement site
Able to hear instructions regardless of use of hearing instrument
Key exclusion criteria
Diagnosed with dementia
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Shigematsu |
Organization
Mie University
Division name
Faculty of Education
Zip code
5148507
Address
1577 Kurimamachiya, Tsu, Mie
TEL
059-231-9294
rshige@edu.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Shigematsu |
Organization
Mie University
Division name
Faculty of Education
Zip code
5148507
Address
1577 Kurimamachiya, Tsu, Mie
TEL
059-231-9294
Homepage URL
rshige@edu.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University
Address
1577 Kurimamachiya, Tsu, Mie
Tel
+81-59-231-9294
rshige@edu.mie-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
保健センター、包括支援センター、公民館（三重県）
Public health center, comprehensive life support center, and community center in Mie Prefecture
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/report/KAKENHI-PROJECT-25350885/25350885seika/
Publication of results
Published
Result
URL related to results and publications
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=2ahUKEwiX8-Wto5zi
Number of participants that the trial has enrolled
168
Results
A protocol was developed as follows: if an older adult fails to accurately complete the allocated stepping pattern (Step Pattern C for aged 75 years or younger; Pattern B for aged 76 years or older), he/she may be considered as possible mild cognitive impairment (MCI). The protocol showed high sensitivity (69.0%) and specificity (76.2%) and a low false positive rate (23.8%) when applying to all the participants.
Results date posted
| 2019 | Year | 05 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Those aged 65 years or older participated in the study. They were required a walking fitness because they needed to come to a study venue. Those who could not hear staff's instruction were excluded from the study.
Participant flow
All of the older adults were accepted as subject. The number of participants were 168 (59 men, 109 women).
Adverse events
None
Outcome measures
Montreal Cognitive Assessment (MoCA) and Square-Stepping achievement
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Relationship between exercise performance test (SSE) and cognitive function (MoCA)
Management information
Registered date
| 2015 | Year | 03 | Month | 25 | Day |
Last modified on
| 2019 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019622
| Research Plan | |
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| 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 |
