UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002309 |
|---|---|
| Receipt number | 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 17:39:28 |
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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
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
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002821
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
