UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016511
Receipt No. 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

* 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
Email 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
Email akito-yamamoto@i.shizuoka-pho.jp

Sponsor
Institute Shizuoka General Hospital
Institute
Department

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
Email 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
URL(English) 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


Contact us.