UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006031 |
|---|---|
| Receipt number | R000007138 |
| Scientific Title | Effect of pulmonary rehabilitation on chronic respiratory disease patients. |
| Date of disclosure of the study information | 2011/07/23 |
| Last modified on | 2015/07/28 16:52:06 |
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Basic information
Public title
Effect of pulmonary rehabilitation on chronic respiratory disease patients.
Acronym
Effect of pulmonary rehabilitation on chronic respiratory disease patients.
Scientific Title
Effect of pulmonary rehabilitation on chronic respiratory disease patients.
Scientific Title:Acronym
Effect of pulmonary rehabilitation on chronic respiratory disease patients.
Region
| Japan |
Condition
Condition
chronic respiratory disease
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect of pulmonary rehabilitation in chronic respiratory disease patients on syapnea, respiratory function,blood gas,QOL and chest wall motion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
respiratory function test
QOL questionnair
(VAS scale,the St George's questionnair)
blood gas
Key secondary outcomes
chest wall motion(ddynamic MRI)
lebel of daily activities
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
over once a week,
term under 3months,
total 12 times.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
chronic respiratory dissease patients
Key exclusion criteria
1) acute heart disease
2) severe hypertention
3) severe pulmonary hupertention
4) severe liver failute or renal failure
5) severe orthopaedics disease
6) resent pneumothoras (within 3months)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaku Yoshimi |
Organization
Juntendo University
Division name
respiratory medicine
Zip code
Address
3-1-3 Hongo,Bunkyo-ku Tokyo
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University
Division name
respiratory medicine
Zip code
Address
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
department of respiratory medicine
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
department of respiratory medicine
Juntendo University
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
| 2011 | Year | 07 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | 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
Management information
Registered date
| 2011 | Year | 07 | Month | 23 | Day |
Last modified on
| 2015 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007138
