UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004878 |
|---|---|
| Receipt number | 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 00:15:25 |
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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
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
hoffmaka@mac.com
Sponsor or person
Institute
Medical University Graz
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005808
| Research Plan | |
|---|---|
| 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 |
