UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005348
Receipt No. R000006356
Scientific Title Daily activity in idiopathic pulmonary fibrosis
Date of disclosure of the study information 2011/03/31
Last modified on 2016/02/23

* 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 Daily activity in idiopathic pulmonary fibrosis
Acronym Daily activity in IPF
Scientific Title Daily activity in idiopathic pulmonary fibrosis
Scientific Title:Acronym Daily activity in IPF
Region
Japan

Condition
Condition idiopathic pulmonary fibrosis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the relationship between daily activity and disease severity in IPF
Basic objectives2 Others
Basic objectives -Others Cross-sectional observation
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1) Daily activity measured by an accelerometer
2) Pulmonary function test
3) Arterial blood gas analysis
4) 6-min walk test
Key secondary outcomes 1) Daily dyspnea (BDI, modified MRC)
2) Health-related quality of life (SGRQ)
3) Depression (HADS)
4) Mental status (MMSE)

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with IPF diagnosed with ATS/ERS/JRS/ALAT guideline 2011
2) Without any infection and acute exacerbation within 3 mo
3) Written informed consent
Key exclusion criteria 1) Patients with uncontrolled comorbidities
2) Patients who cannot undergo pulmonary function test and/or 6-min walk test
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Nishiyama
Organization Kinki University School of Medicine
Division name Department of Respiratory Medicine and Allergology
Zip code
Address 377-2 Onohigashi, Osaka-sayama, Osaka, Japan
TEL 072-366-0221
Email nishi-o@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Nishiyama
Organization Kinki University School of Medicine
Division name Department of Respiratory Medicine and Allergology
Zip code
Address 377-2 Onohigashi, Osaka-sayama, Osaka, Japan
TEL 072-366-0221
Homepage URL
Email nishi-o@med.kindai.ac.jp

Sponsor
Institute Department of Respiratory Medicine and Allergology, Kinki University School of Medicine
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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 近畿大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 31 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
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 Completed
Date of protocol fixation
2010 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2011 Year 03 Month 30 Day
Last modified on
2016 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006356

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.