UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058624 |
|---|---|
| Receipt number | R000066964 |
| Scientific Title | Impact of high oxygen concentration on excercise duration in patients with interstitial lung disease following acute exacerbation |
| Date of disclosure of the study information | 2025/07/29 |
| Last modified on | 2025/07/29 00:18:22 |
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Basic information
Public title
Impact of high oxygen concentration on excercise duration in patients with interstitial lung disease following acute exacerbation
Acronym
Impact of high oxygen concentration on excercise duration in patients with interstitial lung disease following acute exacerbation
Scientific Title
Impact of high oxygen concentration on excercise duration in patients with interstitial lung disease following acute exacerbation
Scientific Title:Acronym
Impact of high oxygen concentration on excercise duration in patients with interstitial lung disease following acute exacerbation
Region
| Japan |
Condition
Condition
Interstitial Lung Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate whether high-concentration oxygen delivered via HFNC could improve exercise capacity in patients during the recovery phase following AE-ILD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endurance time
Key secondary outcomes
SpO2, HR, RR
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
High-flow nasal cannula (40L/min, FiO2 60%)
Interventions/Control_2
High-flow nasal cannula (40L/min, FiO2 21%)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
acute exacerbation of interstitial lung disease
Key exclusion criteria
Patients who were unable to undergo the constant-load ergometry test (CLET) owing to motor dysfunction, cognitive dysfunction, or other diseases were excluded.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hikaru |
| Middle name | |
| Last name | Machiguchi |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Rehabilitation
Zip code
236-0051
Address
6-16-1 Tomioka-higashi, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-701-9581
h.machiguchi6008@gmail.com
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Machiguchi |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Rehabilitation
Zip code
236-0051
Address
6-16-1 Tomioka-higashi, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-701-9581
Homepage URL
h.machiguchi6008@gmail.com
Sponsor or person
Institute
Seirei Mikatahara General Hospital, Dept. of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Seirei Mikatahara General Hospital
Address
3453 Mikatahara-cho, Kita-ku, Hamamatsu, Shizuoka
Tel
053-436-1251
h.machiguhci6008@gmail.com
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 | 07 | Month | 29 | Day |
Related information
URL releasing protocol
no
Publication of results
Unpublished
Result
URL related to results and publications
no
Number of participants that the trial has enrolled
25
Results
High-concentration HFNC significantly improved the endurance time and minimum SpO2, and reduced the HR and RR compared to low-concentration HFNC (p<0.05).
Results date posted
| 2025 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
average age: 74.8years, %FVC: 72.3 (65.9-95.5), %FEV1: 75.1 (70.2-102.2), %DLCO: 48.2 (40.1-63.9)
Participant flow
25 cases of acute exacerbation of interstitial lung disease that resulted in hospitalization from December 2018 to October 2019 were recruited.
Adverse events
No
Outcome measures
endurance time, peripheral oxygen saturation (SpO2), heart rate (HR), respiratory rate (RR), modified Borg scale
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066964
