UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056890 |
|---|---|
| Receipt number | R000064970 |
| Scientific Title | Investigation of Changes in Physical Function and Health-Related Quality of Life Associated with Acute Exacerbations of Interstitial Lung Disease and Their Contributing Factors |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/31 16:19:13 |
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Basic information
Public title
Investigation of Changes in Physical Function and Health-Related Quality of Life Associated with Acute Exacerbations of Interstitial Lung Disease and Their Contributing Factors
Acronym
ILD Acute Exacerbation, Physical Function and QOL Study
Scientific Title
Investigation of Changes in Physical Function and Health-Related Quality of Life Associated with Acute Exacerbations of Interstitial Lung Disease and Their Contributing Factors
Scientific Title:Acronym
ILD Acute Exacerbation, Physical Function and QOL Study
Region
| Japan |
Condition
Condition
Interstitial Lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in physical function and health-related quality of life after acute exacerbation in patients with interstitial lung disease and identify contributing factors.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to assess changes in physical function and health-related quality of life (HRQOL) following an acute exacerbation in patients with interstitial lung disease and to identify contributing factors.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
exercise capacity
Key secondary outcomes
health-related quality of life (HRQOL)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A Case of Acute Exacerbation of Interstitial Lung Disease Requiring Hospitalization and Treatment
Key exclusion criteria
Impossibility of conducting exercise function evaluation, inability to obtain consent, unstable pneumothorax and mediastinal emphysema, unstable condition, and the introduction of a pulmonary rehabilitation program following acute exacerbation
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | tomoya |
| Middle name | |
| Last name | ogawa |
Organization
Aichi Shukutoku University
Division name
Faculty of Health and Medical Sciences
Zip code
480-1197
Address
Aichi Shukutoku University 2-9, Katahira, Nagakute, Aichi
TEL
0561624111
toogawa@asu.aasa.ac.jp
Public contact
Name of contact person
| 1st name | tomoya |
| Middle name | |
| Last name | ogawa |
Organization
Aichi Shukutoku University
Division name
Faculty of Health and Medical Sciences
Zip code
480-1197
Address
2-9, Katahira, Nagakute, Aichi
TEL
0561624111
Homepage URL
toogawa@asu.aasa.ac.jp
Sponsor or person
Institute
Aichi Shukutoku University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tosei General Hospital
Address
160 Nishioiwake-cho, Seto city, Aichi, Japan
Tel
0561-82-5101
ychikenn@tosei.or.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
| 2025 | Year | 04 | 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
| 2024 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective extraction of evaluation items from medical records at 1 month and 6 months after acute exacerbation in interstitial lung disease
Management information
Registered date
| 2025 | Year | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064970
