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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021951
Receipt No. R000025315
Scientific Title Efficacy of 4-metre gait speed in the patients with chronic interstitial pneumonia
Date of disclosure of the study information 2016/04/18
Last modified on 2019/11/05

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Basic information
Public title Efficacy of 4-metre gait speed in the patients with chronic interstitial pneumonia
Acronym 4-metre gait speed and chronic interstitial pneumonia
Scientific Title Efficacy of 4-metre gait speed in the patients with chronic interstitial pneumonia
Scientific Title:Acronym 4-metre gait speed and chronic interstitial pneumonia
Region
Japan

Condition
Condition Chronic interstitial pneumonia
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the association between 4-metre gait speed and the most used exercise capacity field test, the 6-minute walk test, in patients with chronic interstitial pneumonia. And, to evaluate the determinants and factors influencing 4-metre gait speed in patients with chronic interstitial pneumonia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 6-minute walk test
Key secondary outcomes Pulmonary function test, Serological marker, Findings of HRCT, Cardiac ultrasonography, Right heart catheterization, Presence or absence of acute exacerbation, Survival rate at 12 months

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 4-metre gait speed
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 Patients who are diagnosed as chronic interstitial pneumonia, as defined by clinical course and the findings of HRCT.
Key exclusion criteria 1. The patients who disagree with involving in this study.
2. The patients had an exacerbation within the preceding 4 weeks.
3. The patients who diagnosed as respiratory disorders other than chronic interstitial pneumonia, malignancy, overt cardiac failure, and hepatic and renal disease.
4. The patients had a predominant neuromuscular limitation to walking.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name SHUJI
Middle name
Last name OH-ISHI
Organization National Hospital Organization Ibarakihigashi National Hospital
Division name Department of Respiratory Medicine
Zip code 319-1113
Address 825 Terunuma, Tokai-mura, Naka-gun, Ibaraki 319-1113, Japan
TEL +81-29-282-1151
Email ooishi.shuji.dg@mail.hosp.go.jp

Public contact
Name of contact person
1st name SHUJI
Middle name
Last name OH-ISHI
Organization National Hospital Organization Ibarakihigashi National Hospital
Division name Department of Respiratory Medicine
Zip code 319-1113
Address 825 Terunuma, Tokai-mura, Naka-gun, Ibaraki 319-1113, Japan
TEL +81-29-282-1151
Homepage URL
Email ooishi.shuji.dg@mail.hosp.go.jp

Sponsor
Institute Department of Respiratory Medicine, National Hospital Organization Ibarakihigashi National Hospital
Institute
Department

Funding Source
Organization National Hospital Organization Ibarakihigashi National 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 National Hospital Organization Ibarakihigashi National Hospital
Address 825 Terunuma, Tokai-mura, Naka-gun, Ibaraki 319-1113, Japan
Tel +81292821151
Email yamano.yoichi.pn@mail.hosp.go.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
2016 Year 04 Month 18 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 72
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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
2016 Year 02 Month 26 Day
Anticipated trial start date
2016 Year 04 Month 18 Day
Last follow-up date
2021 Year 04 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Up to now, total of 72 patients joined in this study. 4MGS, 6MWT,and IKE were measured in all participants. There seemed to be a positive correlation between 4MGS and IKE in elderly group (75-years-old or more),whereas such a correlation seemed not to exist in non-elderly group, suggesting that othe factors may influence the reslut of 4MGS in non-elderly group. The above results were presented in 2018 Annual Meeting of European Respiratory Society (Paris).

Management information
Registered date
2016 Year 04 Month 17 Day
Last modified on
2019 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025315

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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