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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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