UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057104 |
|---|---|
| Receipt number | R000065263 |
| Scientific Title | The Effect of Supplemental Oxygen on Tissue Oxygen Saturation During Exercise in patients with Interstitial Lung Disease |
| Date of disclosure of the study information | 2025/02/25 |
| Last modified on | 2025/02/21 10:39:49 |
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Basic information
Public title
The Effect of Supplemental Oxygen on Tissue Oxygen Saturation During Exercise in patients with Interstitial Lung Disease
Acronym
The Effect of Supplemental Oxygen on Tissue Oxygen Saturation During Exercise in patients with Interstitial Lung Disease
Scientific Title
The Effect of Supplemental Oxygen on Tissue Oxygen Saturation During Exercise in patients with Interstitial Lung Disease
Scientific Title:Acronym
The Effect of Supplemental Oxygen on Tissue Oxygen Saturation During Exercise in patients with Interstitial Lung Disease
Region
| Japan |
Condition
Condition
Interstitial Lung Disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess the effect of supplemental oxygen on quadriceps muscle tissue oxygen saturation (StO2) and exercise capacity in patients with ILD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-minute walk distance, StO2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
4 L/min supplemental oxygen, During the 6-minute walking test
Interventions/Control_2
room air
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
interstitial lung disease
Key exclusion criteria
1. Subjects whose pulse oximeter is judged to be insensitive
2. Subjects with orthopedic diseases, peripheral arterial diseases, etc. that would prevent evaluation
3. Subjects who could not obtain consent for the study, or who wished to withdraw consent and discontinue the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | SHINICHI |
| Middle name | |
| Last name | ARIZONO |
Organization
Seirei Christopher University
Division name
School of Rehabilitation science
Zip code
433-8558
Address
3453 Mikataha Chuo-ku, Hamamatsu
TEL
053-439-1400
arizono-s@umin.ac.jp
Public contact
Name of contact person
| 1st name | SHINICHI |
| Middle name | |
| Last name | ARIZONO |
Organization
Seirei Christopher University
Division name
School of Rehabilitation science
Zip code
433-8558
Address
3453 Mikataha Chuo-ku, Hamamatsu
TEL
053-439-1400
Homepage URL
arizono-s@umin.ac.jp
Sponsor or person
Institute
Seirei Christopher University
Institute
Department
Personal name
SHINICHI ARIZONO
Funding Source
Organization
no
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 Christopher University
Address
3453 Mikataha Chuo-ku, Hamamatsu
Tel
053-439-1400
shinichi-a@seirei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
22016
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 | 02 | Month | 25 | 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
40
Results
Supplemental oxygen significantly increased 6MWD compared to room air (p < 0.05). Additionally, nadir StO2 improved with oxygen supplementation (p < 0.05), as did nadir SpO2 (p < 0.05).
Results date posted
| 2025 | Year | 02 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
FVC(%FVC): 2.0L(66.1%), FEV1.0(%FEV1.0): 1.77L(86.1%), %DLCO: 55.3%
Participant flow
We recruited stable 40 ILD patients who were not on long-term oxygen therapy.
Adverse events
NO
Outcome measures
6-minute walk distance (6MWD), quadriceps muscle tissue oxygen saturation (StO2), peripheral oxygen saturation (SpO2)
Plan to share IPD
NO
IPD sharing Plan description
NO
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 03 | 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 | 02 | Month | 21 | Day |
Last modified on
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065263
