UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019818 |
|---|---|
| Receipt number | 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 11:41:35 |
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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
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
arizono-s@umin.ac.jp
Sponsor or person
Institute
Tosei General 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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022887
| 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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