UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062192 |
|---|---|
| Receipt number | R000071168 |
| Scientific Title | Relationship between the Risk of Falls and Breathing |
| Date of disclosure of the study information | 2026/07/10 |
| Last modified on | 2026/07/09 19:31:22 |
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Basic information
Public title
Relationship between the Risk of Falls and Breathing
Acronym
Risk of Falls and Breathing
Scientific Title
Relationship between the Risk of Falls and Breathing
Scientific Title:Acronym
Risk of Falls and Breathing
Region
| Japan |
Condition
Condition
Falls
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to quantify thoracic and abdominal movements during breathing using a newly developed iPad-based breathing measurement app (BREVI), and to examine differences in breathing parameters between individuals with and without a history of falls.
Basic objectives2
Others
Basic objectives -Others
By clarifying the relationship between fall risk and breathing parameters, grip strength and PROMs (patient-reported outcomes), the study aims to propose new indicators for fall prevention.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Breathing parameters using BREVI
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy individuals aged 30 or over at the time of obtaining consent
Individuals from whom written consent to participate in the study has been obtained
Key exclusion criteria
Individuals who are unable to walk unaided without walking aids such as a walking stick or walking frame
Individuals with a history of respiratory conditions such as asthma
Individuals who have been certified as requiring support or long-term care
Individuals currently undergoing outpatient treatment or medication for mental health conditions, or who have a history of mental illness
Individuals who have a history of surgery on the chest, abdomen, lower limbs or spine
Individuals with a history of osteoarthritis of the knee or hip
Individuals with a current or past history of cerebrovascular disease or neurodegenerative disorders
Individuals with severe spinal deformity
Individuals with severe visual impairment
Pregnant women
Any other individuals deemed unsuitable by the principal investigator or co-investigators
Target sample size
144
Research contact person
Name of lead principal investigator
| 1st name | Akimoto |
| Middle name | |
| Last name | Nimura |
Organization
Institute of Science Tokyo
Division name
Dept. of Functional Joint Anatomy
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku
TEL
03-5803-5279
nimura.orj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Akimoto |
| Middle name | |
| Last name | Nimura |
Organization
Institute of Science Tokyo
Division name
Dept. of Functional Joint Anatomy
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku
TEL
03-5803-5279
Homepage URL
nimura.orj@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
JA Kyosai Research Institute
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
Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku
Tel
03-5803-4547
rinri.adm@tmd.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 | 07 | Month | 10 | 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 | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Targeting a broad demographic aged between 30 and 60, we will measure chest and abdominal movements during rest and deep breathing whilst lying down, using the iPad-based respiratory monitoring app BREVI, which utilises depth sensors. Through this, we aim to clarify the impact of a history of falls on respiratory pattern features, analyse correlations with grip strength and various PROMs, and establish new health indicators based on respiration.
Management information
Registered date
| 2026 | Year | 07 | Month | 09 | Day |
Last modified on
| 2026 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071168
