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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002309
Receipt No. R000002821
Scientific Title Effects of pulmonary rehabilitation on dyspnea, exercise capacity and health status in patients with idiopathic pulmonary fibrosis.
Date of disclosure of the study information 2009/08/09
Last modified on 2009/08/08

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Basic information
Public title Effects of pulmonary rehabilitation on dyspnea, exercise capacity and health status in patients with idiopathic pulmonary fibrosis.
Acronym Effectiveness of pulmonary rehabilitation in patients with idiopathic pulmonary fibrosis.
Scientific Title Effects of pulmonary rehabilitation on dyspnea, exercise capacity and health status in patients with idiopathic pulmonary fibrosis.
Scientific Title:Acronym Effectiveness of pulmonary rehabilitation in patients with idiopathic pulmonary fibrosis.
Region
Japan

Condition
Condition idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD)
Classification by specialty
Pneumology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of pulmonary rehabilitation on dyspnea, exercise capacity and health status in subjects with IPF and compare the responses in subjects with IPF with the changes seen in a control group of COPD subjects who underwent an identical pulmonary rehabilitation program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes dyspnea, muscle force, exercise capacity, activities of daily living (ADL) and health status
Key secondary outcomes

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
Behavior,custom Maneuver
Interventions/Control_1 pulmonary rehabilitation (exercise training, breathing retraining and patients education) for IPF group.
Interventions/Control_2 pulmonary rehabilitation (exercise training, breathing retraining and patients education) for COPD group.
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 with dyspnea on exertion leading to a limitation in daily activities (Medical Research Council [MRC] grade > 1) and were on stable medical treatment.
Clinically stable for at least 4 weeks.
Key exclusion criteria Patients with collagen vascular disease, occupational lung disease, sarcoidosis, hypersensitivity pneumonitis and other idiopathic interstitial pneumonias were excluded.
Others were MRC grade 5, severe orthopedic or neurological disorders limiting exercise performance, unstable cardiac disease, inability to understand or complete questionnaires and previous participation in a pulmonary rehabilitation program.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryo Kozu
Organization Nagasaki University Hospital
Division name Rehabilitation Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagasaki University Hospital
Division name Rehabilitation Medicine
Zip code
Address
TEL 095-819-7258
Homepage URL
Email

Sponsor
Institute Nagasaki University 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
2009 Year 08 Month 09 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
2003 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2003 Year 07 Month 01 Day
Last follow-up date
2008 Year 08 Month 01 Day
Date of closure to data entry
2008 Year 08 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 08 Day
Last modified on
2009 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002821

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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