UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031799 |
|---|---|
| Receipt number | R000036301 |
| Scientific Title | The effect of the order made preventive care based on analyzing self-problems by local residences |
| Date of disclosure of the study information | 2018/03/19 |
| Last modified on | 2022/09/24 14:53:30 |
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Basic information
Public title
The effect of the order made preventive care based on analyzing self-problems by local residences
Acronym
The preventive care based on analyzing self-problems
Scientific Title
The effect of the order made preventive care based on analyzing self-problems by local residences
Scientific Title:Acronym
The preventive care based on analyzing self-problems
Region
| Japan |
Condition
Condition
frailty
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To inspect the effect of the order made preventive care based on analyzing self-problems by local residences
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the living conditions measured by the basic check list after four and ten months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
the preventive care based on analyzing self-problems by participants
Interventions/Control_2
the conventional action in the local voluntary 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Man and woman 65 years or older participating the local voluntary group
Key exclusion criteria
The elderly who has difficulty in exercise or in participating the local voluntary group
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Shinohara |
Organization
Takasaki University of Health and Welfare
Division name
Department of Physical Therapy, Faculty of Health Care
Zip code
370-0033
Address
501, Nakaorui-machi, Takasaki-shi, Gunma
TEL
0273521291
shinohara-t@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Shinohara |
Organization
Takasaki University of Health and Welfare
Division name
Department of Physical Therapy, Faculty of Health Care
Zip code
370-0033
Address
501, Nakaorui-machi, Takasaki-shi, Gunma
TEL
0273521291
Homepage URL
shinohara-t@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
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
Research Ethics Committee, Takasaki University of Health and Welfare
Address
501, Nakaorui-machi, Takasaki-shi, Gunma
Tel
0273521291
mune@takasaki-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
| 2018 | Year | 03 | Month | 19 | Day |
Related information
URL releasing protocol
https://doi.org/10.1080/09593985.2021.1934927
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1080/09593985.2021.1934927
Number of participants that the trial has enrolled
56
Results
There were no significant differences in consciousness or behavior between the groups. The score was higher in the intervention than in the control group at 40 weeks in section I of the Brief-BESTest, indicating that the muscle strength contributed to balance function.
Results date posted
| 2022 | Year | 09 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants were recruited from two different groups at the community centers in Takasaki-city, Gunma, Japan.
Participant flow
Overall, 13 (56.5%) and 12 (60.0%) participants in the intervention and control groups were included in the final analysis, respectively.
Adverse events
None.
Outcome measures
The primary outcome was the consciousness and behavior related to health. Physical functions were the secondary outcomes and were assessed using the handgrip strength, quadriceps strength, ASMI, Brief-BESTest, and TUG tests.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2018 | Year | 03 | Month | 19 | Day |
Last modified on
| 2022 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036301
| 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 |
