UMIN-CTR Clinical Trial

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

At 2018, 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). At present, we are following up on the patients enrolled in this study to confirm whether 4MGS is related to the exacerbation of the disease or their prognosis.

Management information
Registered date	2016 Year 04 Month 17 Day
Last modified on	2020 Year 11 Month 10 Day

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