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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019818
Receipt No. R000022887
Scientific Title Pulmonary rehabilitation in patients with idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease
Date of disclosure of the study information 2015/11/17
Last modified on 2015/11/30

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Basic information
Public title Pulmonary rehabilitation in patients with idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease
Acronym Pulmonary rehabilitation in patients with IPF and COPD
Scientific Title Pulmonary rehabilitation in patients with idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease
Scientific Title:Acronym Pulmonary rehabilitation in patients with IPF and COPD
Region
Japan

Condition
Condition idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease
Classification by specialty
Pneumology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This purpose is to evaluate the efficacy of pulmonary rehabilitation in patients with IPF and COPD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes exercise capacity
(following 10-weeks pulmonary rehabilitation)
Key secondary outcomes Baseline dyspnea index, St. George`s Respiratory Questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 IPF
Pulmonary rehabilitation
10-week
twice-weekly
Interventions/Control_2 COPD
Pulmonary rehabilitation
10-week
twice-weekly
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
75 years-old >
Gender Male and Female
Key inclusion criteria In IPF patients, inclusion criteria were as follows: (i) age less than 75 years; (ii) diagnosis of IPF; (iii) shortness of breath on effort; and (iv) stable clinical condition with no infection or exacerbation in the previous three months.

Inclusion criteria for COPD patients were as follows: patient-reported exertional dyspnea; a constant medication regimen without any history of an acute exacerbation for at least 3 months prior to recruitment.
(i) a history of smoking of more than 20 pack-years, (ii) a FEV1 / forced vital capacity (FVC) of less than 70%
Key exclusion criteria Exclusion criteria in IPF were severe comorbid illnesses, collagen vascular diseases, and the need for long-term oxygen therapy.

The exclusion criteria included a history of lung surgery, the use of long-term oxygen therapy.
(i) no clinical diagnosis of asthma.

Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Taniguchi
Organization Tosei General Hospital
Division name Department of Respiratory Medicine and Allergy
Zip code
Address 160 Nishioiwake, Seto
TEL 0561-82-5101
Email taniguchi@tosei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Arizono
Organization Seirei Christopher University
Division name School of Rehabilitation Sciences
Zip code
Address 3453 Mikatahara, Kitaku, Hamamatsu
TEL 053-439-1400
Homepage URL
Email arizono-s@umin.ac.jp

Sponsor
Institute Tosei General Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 17 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
2008 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 17 Day
Last modified on
2015 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022887

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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