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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004878
Receipt No. R000005808
Scientific Title Positive Effect of Abdominal Breathing Exercise on Gastroesophageal Reflux Disease: A Randomised, Controlled Study
Date of disclosure of the study information 2011/01/14
Last modified on 2018/02/06

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Basic information
Public title Positive Effect of Abdominal Breathing Exercise on Gastroesophageal Reflux Disease:
A Randomised, Controlled Study
Acronym GERD and breathing training
Scientific Title Positive Effect of Abdominal Breathing Exercise on Gastroesophageal Reflux Disease:
A Randomised, Controlled Study
Scientific Title:Acronym GERD and breathing training
Region
Europe

Condition
Condition Gastroesophageal reflux disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evluate the effect of abdominal breathing exercises on the lower esophageal sphincter
Basic objectives2 Others
Basic objectives -Others effect on GERD symptoms
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fraction of gastric pH below 4
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 abdominal breathing training
Interventions/Control_2 no abdomina breathing
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria non erosive GERD
on demand PPI therapy
Key exclusion criteria erosive GERD
large Hernia
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Andreas J Eherer
Organization Medical University Graz
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address Auenbruggerplatz 30, A-8036 Graz, Austria
TEL 4331638581791
Email

Public contact
Name of contact person
1st name
Middle name
Last name Karl Martin Hoffmann
Organization Medical University Graz
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address Auenbruggerplatz 30
TEL
Homepage URL
Email hoffmaka@mac.com

Sponsor
Institute Medical University Graz
Institute
Department

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
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
2011 Year 01 Month 14 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
2004 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 11 Month 01 Day
Last follow-up date
2006 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2006 Year 12 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 14 Day
Last modified on
2018 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005808

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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