UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021656 |
|---|---|
| Receipt number | R000024972 |
| Scientific Title | Lung Inflation Training Using a Positive End-expiratory Pressure Valve in Patients with Duchenne Muscular Dystrophy - A Randomized Single-blinded Crossover Pilot Study |
| Date of disclosure of the study information | 2016/03/28 |
| Last modified on | 2016/03/28 18:01:35 |
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Basic information
Public title
Lung Inflation Training Using a Positive End-expiratory Pressure Valve in Patients with Duchenne Muscular Dystrophy - A Randomized Single-blinded Crossover Pilot Study
Acronym
Inflation Training of Randomized Single-blinded Crossover Pilot StudyLung with Duchenne Muscular Dystrophy
Scientific Title
Lung Inflation Training Using a Positive End-expiratory Pressure Valve in Patients with Duchenne Muscular Dystrophy - A Randomized Single-blinded Crossover Pilot Study
Scientific Title:Acronym
Inflation Training of Randomized Single-blinded Crossover Pilot StudyLung with Duchenne Muscular Dystrophy
Region
| Japan |
Condition
Condition
Duchenne Muscular Dystrophy
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the short-term effects of lung inflation training using a positive end-expiratory pressure valve in patients with DMD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
change in PEEP insufflation capacity from baseline over
Key secondary outcomes
Relatively low PEEP (15 cmH2O) may be adequate for lung inflation training in DMD.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
PEEP valve with lung expansion training,washout period,
lung inflation training
Interventions/Control_2
lung inflation training,
washout period,
PEEP valve with lung expansion training
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
| 17 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male
Key inclusion criteria
diagnosed on the basis of a clinical history
physical findings
genetic evaluation
muscle enzymes
electromyography
DNA analysis or muscle biopsy
Key exclusion criteria
an episode of infection
a tracheotomy
obvious bullae
bronchial asthma
a history of pneumothorax
severe congestive heart failure
were ventilator-dependent
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukiko Tajima |
Organization
National Higashisaitama Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
4147 Kurohama,Hasuda,Saitama,Japan
TEL
048-768-1161
yukyytajima@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiyuki Kawakami |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-5363-3832
Homepage URL
michiyukikawakami@hotmail.com
Sponsor or person
Institute
National Higashisaitama Hospital
Institute
Department
Personal name
Funding Source
Organization
National Higashisaitama Hospital
Organization
Division
Category of Funding Organization
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
| 2016 | Year | 03 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 31 | 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
| 2016 | Year | 03 | Month | 28 | Day |
Last modified on
| 2016 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024972
