UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016511 |
|---|---|
| Receipt number | R000019175 |
| Scientific Title | SpO2 area of the 6 minute-walk test |
| Date of disclosure of the study information | 2015/02/16 |
| Last modified on | 2021/02/22 12:26:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
SpO2 area of the 6 minute-walk test
Acronym
SpO2 area of the 6 minute-walk test
Scientific Title
SpO2 area of the 6 minute-walk test
Scientific Title:Acronym
SpO2 area of the 6 minute-walk test
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis
Chronic Obstructive Pulmonary Disesase
Combined Pulmonary Fibrosis and Emphysema
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of the SpO2 area in patients with IPF/COPD/CPFE.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in SpO2 area
Key secondary outcomes
1.Change in 6 minute-walk distance.
2.Changes in pulmonary function test(VC, FVC, FEV1, FEV1/FVC, DLco, DLco/VA, R5, R20, R5-R20, X5, Fres, ALX).
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. FVC>1.0L in IPF/CPFE patients
2. 30%<=%FEV1<80% in COPD patients
3. all patients provide written informed consent.
Key exclusion criteria
1. patients who received therapy of the lung cancer.
2. patient who have treatment with the home oxygen therapy.
3. patients who had a history of the angina pectoralis within 1 month.
4. patient who have walking disturbance.
5. considered ineligible for the study by the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akito |
| Middle name | |
| Last name | Yamamoto |
Organization
Shizuoka General Hospital
Division name
Respiratory medicine
Zip code
420-8527
Address
4-27-,Kita-ando,Aoi-ward,Shizuoka,Shizuoka,Japan
TEL
054-247-6111
akito-yamamoto@i.shizuoka-pho.jp
Public contact
Name of contact person
| 1st name | Akito |
| Middle name | |
| Last name | Yamamoto |
Organization
Shizuoka General Hospital
Division name
Respiratory medicine
Zip code
420-8527
Address
4-27-,Kita-ando,Aoi-ward,Shizuoka,Shizuoka,Japan
TEL
054-247-6111
Homepage URL
akito-yamamoto@i.shizuoka-pho.jp
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka General Hospital
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
Shizuoka General Hospital
Address
4-27-,Kita-ando,Aoi-ward,Shizuoka,Shizuoka,Japan
Tel
054-247-6111
chiken-sougou@shizuoka-pho.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
| 2015 | Year | 02 | Month | 16 | Day |
Related information
URL releasing protocol
https://www.tandfonline.com/doi/full/10.1080/15412555.2020.1844176
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/15412555.2020.1844176
Number of participants that the trial has enrolled
57
Results
In multivariate regression analysis, a 6MWD less than 350m was independently predicted by CAT scores and inspiratory R5. In ROC, the AUC was 0.76, 0.78, and 0.85 for CAT scores, R5, and CAT scores plus R5, respectively, with the best cutoff value of 17 and 2.82 cmH20/L/s. In conclusion, inspiratory R5, predicted low exercise tolerance in COPD subjects.
Results date posted
| 2021 | Year | 02 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This was a prospective, observational study. Fifty-seven subjects with COPD who attended outpatient clinics for routine checkups at Shizuoka General Hospital between April 2015 and April 2016.
Participant flow
Of the 57 total subjects, 43 (75.4%) had a 6MWD and over 350m, and 14 (24.6%) had a 6MWD less than 350m.
Adverse events
None, as this is an observational study.
Outcome measures
Modified MRC dyspnea scale (mMRC), COPD Assessment Test (CAT), oscillometry, spirometry, and 6MWT were performed in a stable condition. The participants were classified into subjects with 6MWD and over 350m or 6MWD less than 350m, and the predictor of 6MWD less than 350m was assessed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Study design
1. A prospective, obserbational study
2. Method: To compare changes in Pulmnary Function Test,6 minute-walk test. 1-year changes for patients with mild to moderate stable IPF/COPD/CPFE.
Management information
Registered date
| 2015 | Year | 02 | Month | 11 | Day |
Last modified on
| 2021 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019175
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
