UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018923 |
|---|---|
| Receipt number | R000021893 |
| Scientific Title | Effects of chest wall compression on expiratory flow rates in patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2015/09/07 |
| Last modified on | 2015/09/07 00:06:27 |
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Basic information
Public title
Effects of chest wall compression on expiratory flow rates in patients with chronic obstructive pulmonary disease
Acronym
Effects of chest wall compression in patients with chronic obstructive pulmonary disease
Scientific Title
Effects of chest wall compression on expiratory flow rates in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym
Effects of chest wall compression in patients with chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
normal subjects
Classification by specialty
| Pneumology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of chest wall compression on expiratory flow rates in patients with COPD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
expiratory flow rates during chest wall compression
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
chest wall compression
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clinically stable patients with COPD (stage I-IV disease according to the Global Initiative for Chronic Obstructive Lung Disease guidelines) who were receiving pulmonary rehabilitation at the Hyogo College of Medicine Sasayama Medical Center and who could perform spirometric testing according to the ATS/ERS Task Force Guidelines.
Age-matched healthy subjects were also consecutively recruited from the local community.
Key exclusion criteria
suspected asthma; other systemic conditions that could contribute to dyspnea or exercise limitation, such as heart failure or metabolic disorders, and neuromuscular comorbidity limiting all measurements; or non-approval for study participation.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Nozoe |
Organization
Konan Women's University
Division name
Faculty of Nursing and Rehabilitation, Department of Physical Therapy
Zip code
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Japan
TEL
078-431-0391
masafumi.nozoe@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Nozoe |
Organization
Konan Women's University
Division name
Faculty of Nursing and Rehabilitation, Department of Physical Therapy
Zip code
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Japan
TEL
078-431-0391
Homepage URL
masafumi.nozoe@gmail.com
Sponsor or person
Institute
Konan Women's University
Institute
Department
Personal name
Funding Source
Organization
Konan Women's University
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2012 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 07 | Day |
Last modified on
| 2015 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021893
