UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061218 |
|---|---|
| Receipt number | R000070049 |
| Scientific Title | Investigation of Physical Activity Levels and Related Factors in Individuals with Deaf-blindness |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/04/09 21:24:38 |
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Basic information
Public title
A Study on Physical Activity Levels and Related Factors in People with Deaf-blindness
Acronym
Deaf-blind Physical Activity Study
Scientific Title
Investigation of Physical Activity Levels and Related Factors in Individuals with Deaf-blindness
Scientific Title:Acronym
Deaf-Blindness Physical Activity Study
Region
| Japan |
Condition
Condition
Deaf-blindness, Visual impairment, Hearing impairment
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively assess walking, sedentary, and standing time in daily life among individuals with deaf-blindness using an activity monitor, and to describe their physical activity patterns.
Basic objectives2
Others
Basic objectives -Others
This is an observational study aimed at assessing daily physical activity levels in individuals with deaf-blindness using an activity monitor, and does not evaluate safety or efficacy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity level
Key secondary outcomes
Disability profile, Kessler Psychological Distress Scale(K6), University of California, UCLA Loneliness Scale, EuroQol 5-Dimension 5-Level(EQ-5D-5L), International Physical Activity Questionnaire(IPAQ)-Short Form(SF)
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. Individuals aged 18 years or older at the time of obtaining informed consent.
2. Individuals who are able to communicate either independently or with the assistance of a supporter.
3. Individuals who are able to provide written informed consent for participation in this study, either independently or through a supporter.
Key exclusion criteria
1. Individuals who are currently hospitalized or admitted to medical or welfare facilities.
2. Individuals with evident cognitive impairment.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Komiya |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
TEL
0252574723
makoto-komiya@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Komiya |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
TEL
0252574723
Homepage URL
makoto-komiya@nuhw.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
Ethics committee of Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
Tel
0252574455
rinri@nuhw.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
| 2026 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study without intervention. Daily physical activity is measured using a physical activity monitor, and a questionnaire-based survey is conducted. The collected data are used to examine physical activity levels and related factors among individuals with deaf-blindness, visual impairment, and hearing impairment.
Management information
Registered date
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070049
