UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054680 |
|---|---|
| Receipt number | R000062480 |
| Scientific Title | Relationship between daily walking number vs. mental status and social recognition in persons with physical disability |
| Date of disclosure of the study information | 2024/06/18 |
| Last modified on | 2024/06/17 14:33:34 |
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Basic information
Public title
Relationship between physical activity and "Ikigai" (passion for living) in persons with physical disability
Acronym
Significance of physical activity in persons with physical disability
Scientific Title
Relationship between daily walking number vs. mental status and social recognition in persons with physical disability
Scientific Title:Acronym
Daily walking number and mental status and social recoignition in persons with physical disability
Region
| Japan |
Condition
Condition
Persons with physical disability
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between physical activity and "Ikigai"(passion for living) in persons with physical disability whose daily physical activity can be monitored with a pedometer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mental status
Key secondary outcomes
Social recoginition
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who are aged not less than 18 years old
2) Those who hold Disability Handbook
3) Those who work while supported by Aiteiku (Co. Ltd) or who visit workplaces managed by "Poporo-no-kai"(Social welfare corporation)
4) Those who gave us their informed consent to participate in the study
Key exclusion criteria
1) Those who do not clear the inclusion criteria
2) Those who have declined or withdrawed their participation in the study
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2682
masuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto Nagano
TEL
0263-37-2682
Homepage URL
masuki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Graduate School of Medicine
Address
3-1-1 Asahi Matsumoto Nagano
Tel
0263-37-2527
mdrinri@shinshu-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
| 2024 | Year | 06 | Month | 18 | 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
| 2024 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Items for observation and measurement:
Background for subjects (sex, age, height, body mass, complications, history of present illness, medication, recent health check results), average physical activity (walking number) for a consecutive 7 days, mental status (POMSR2)and wage evaluation for working in the working places during the measurement of physical activity
Management information
Registered date
| 2024 | Year | 06 | Month | 17 | Day |
Last modified on
| 2024 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062480
