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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021656
Receipt No. 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

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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
Email 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
Email michiyukikawakami@hotmail.com

Sponsor
Institute National Higashisaitama Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024972

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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