UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021951 |
|---|---|
| Receipt number | 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 | 2020/11/10 08:27:23 |
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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
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
ooishi.shuji.dg@mail.hosp.go.jp
Sponsor or person
Institute
Department of Respiratory Medicine, National Hospital Organization Ibarakihigashi National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025315
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