UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054763 |
|---|---|
| Receipt number | R000062579 |
| Scientific Title | The kinematic and physiological study on obstacle properties for young adults with visual and hearing impairments. |
| Date of disclosure of the study information | 2024/06/25 |
| Last modified on | 2024/12/25 09:08:44 |
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Basic information
Public title
The kinematic and physiological study on obstacle properties for young adults with visual and hearing impairments.
Acronym
Study on Health Risks Based on the Characteristics of Visual and Hearing Impairments
Scientific Title
The kinematic and physiological study on obstacle properties for young adults with visual and hearing impairments.
Scientific Title:Acronym
Study on Health Risks Based on the Characteristics of Visual and Hearing Impairments
Region
| Japan |
Condition
Condition
Visual impairment and Hearing impairment
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
this study aimed to investigate the differences arising from the characteristics of visual and hearing impairments in healthy university students using the orthostatic tolerance test.
Basic objectives2
Others
Basic objectives -Others
Additionally, the study aimed to analyze parameters including indicators of arteriosclerosis and physical motor functions.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Autonomic Nervous Activity Parameters in a Single Orthostatic Tolerance Test
Key secondary outcomes
Appendicular Muscle Mass, Body Fat Percentage, Upper and Lower Limb Muscle Strength, Balance Ability, Cardiac Autonomic Function, Degree of Arteriosclerosis, Physical Activity Level, and Quality of Life (QOL)
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All participants were university students aged 20 and above, including a group of healthy individuals with no visual or hearing impairments, a group of visually impaired individuals (with corrected visual acuity of less than approximately 0.3 in both eyes), and a group of hearing impaired individuals (with a hearing level of approximately 60 decibels or higher in both ears).
Key exclusion criteria
Individuals with acute coronary syndromes such as unstable angina, those with musculoskeletal disorders under medical management, and those whom a physician deems inappropriate for participation in this study based on medical grounds.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Misa |
| Middle name | |
| Last name | Miura |
Organization
Tsukuba University of Technology
Division name
Faculty of Health
Zip code
305-8521
Address
Kasuga 4-12-7, Tsukuba 305-8521, Japan.
TEL
09028881670
m.miura@k.tsukuba-tech.ac.jp
Public contact
Name of contact person
| 1st name | Misa |
| Middle name | |
| Last name | Miura |
Organization
Faculty of Health
Division name
Department of Physical Therapy
Zip code
305-8521
Address
Kasuga 4-12-7, Tsukuba 305-8521, Japan.
TEL
09028881670
Homepage URL
m.miura@k.tsukuba-tech.ac.jp
Sponsor or person
Institute
Tsukuba University of Technology
Institute
Department
Personal name
Misa Miura
Funding Source
Organization
Grants-in-Aid for Scientific Research (KAKENHI)
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
Ethics Committee of Tsukuba University of Technology
Address
Kasuga 4-12-7, Tsukuba 305-8521, Japan.
Tel
029-858-9552
m.miura@k.tsukuba-tech.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
筑波技術大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=202302269251871705
Publication of results
Partially published
Result
URL related to results and publications
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=202302269251871705
Number of participants that the trial has enrolled
34
Results
There were no differences in body composition among the three groups, indicating that there were no intergroup differences in physical function. However, the degree of arteriosclerosis was significantly higher in the hearing-impaired group compared to the healthy group. Among the three groups, the hearing-impaired group had the lowest physical activity level. Furthermore, cardiac parasympathetic activity was lower in the hearing-impaired group compared to the healthy group.
Results date posted
| 2024 | Year | 06 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants were divided into three groups: 11 healthy individuals with no visual or hearing impairments, 10 individuals with visual impairments (corrected visual acuity in both eyes below approximately 0.3), and 13 individuals with hearing impairments (hearing level in both ears above approximately 60 decibels).
Participant flow
The recent observational study included 34 university students over the age of 20 who do not engage in regular exercise and who attended university in Japan, between May 2019 and January 2023.The participants were divided into three groups: 11 healthy individuals with no visual or hearing impairments, 10 individuals with visual impairments (corrected visual acuity in both eyes below approximately 0.3), and 13 individuals with hearing impairments (hearing level in both ears above approximately 60 decibels). Measurements were taken for limb muscle mass, body fat percentage, upper and lower limb muscle strength, balance ability, cardiac autonomic function, arteriosclerosis degree, physical activity level, and QOL. Each parameter was compared and analyzed among the groups. Exclusion criteria included individuals with acute coronary syndrome such as unstable angina, those with musculoskeletal disorders under medical management, and those whom a physician deemed unsuitable for participation in this study based on medical evidence.
Adverse events
None
Outcome measures
HRV analysis during the orthostatic tolerance test, appendicular muscle mass, body fat percentage, upper and lower limb muscle strength, balance ability, cardiac autonomic function, degree of arteriosclerosis, physical activity level, and QOL were evaluated and measured. Differences among the groups for each parameter were compared and analyzed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 30 | Day |
Other
Other related information
Pay attention to the characteristics of disabilities in healthy individuals, visually impaired individuals, and hearing impaired individuals, and strive to ensure the rights of individuals with disabilities.
Management information
Registered date
| 2024 | Year | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062579
