UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029119 |
|---|---|
| Receipt number | R000033299 |
| Scientific Title | Effectiveness of rehabilitation for pulmonary nontuberculous mycobacteriosis:a randomised controlled trial. |
| Date of disclosure of the study information | 2017/09/13 |
| Last modified on | 2017/09/12 22:13:34 |
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Basic information
Public title
Effectiveness of rehabilitation for pulmonary nontuberculous mycobacteriosis:a randomised controlled trial.
Acronym
Effectiveness of rehabilitation for pulmonary nontuberculous mycobacteriosis.
Scientific Title
Effectiveness of rehabilitation for pulmonary nontuberculous mycobacteriosis:a randomised controlled trial.
Scientific Title:Acronym
Effectiveness of rehabilitation for pulmonary nontuberculous mycobacteriosis.
Region
| Japan |
Condition
Condition
pulmonary nontuberculous mycobacteriosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of pulmonary rehabillitation for pulmonary nontuberculous mycobacterial disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Six-Minute Walk Test(before intervention,immediately after rehabilitation,after 6 months)
Key secondary outcomes
Health-related quality of life score(CAT SF-36),blood test,pulmonary function test,quadriceps muscle strength,grip strength
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
rehabilitation group(6-week Twice a week)
Interventions/Control_2
control 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 meet diagnostic criteria for pulmonary nontuberculous mycobacteriosis.
Key exclusion criteria
Patiens who could not walk,had symptomatic heart disease,hospitalized with nontuberculous mycobacterial disease within 2 months,and Patients judged unsuitable as research subjects by Research doctors.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Ikuyama |
Organization
Shinshu University School of Medicine
Division name
First Department of Medicine
Zip code
Address
3-1-1 Asahi, Matsumoto, Japan
TEL
0263-37-2631
ikuyama@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Ikuyama |
Organization
Shinshu University School of Medicine
Division name
First Department of Medicine
Zip code
Address
3-1-1 Asahi, Matsumoto, Japan
TEL
0263-37-2631
Homepage URL
ikuyama@shinshu-u.ac.jp
Sponsor or person
Institute
first Department of Medicine, Shinshu University School of Medicine
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
| 2017 | Year | 09 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 12 | Day |
Last modified on
| 2017 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033299
| Research Plan | |
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| 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 |
