UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012345 |
|---|---|
| Receipt number | R000014437 |
| Scientific Title | Effects of phasic electrical stimulation during expiration in patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2013/11/19 |
| Last modified on | 2013/11/19 16:16:28 |
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Basic information
Public title
Effects of phasic electrical stimulation during expiration
in patients with chronic obstructive pulmonary disease
Acronym
Effects of phasic electrical stimulation during expiration
in patients with chronic obstructive pulmonary disease
Scientific Title
Effects of phasic electrical stimulation during expiration
in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym
Effects of phasic electrical stimulation during expiration
in patients with chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of phasic electrical stimulation during expiration in patients with COPD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
minute ventilation, tidal volume, respiratory rate
Key secondary outcomes
inspiratory time, expiratory time, total respiratory time, dead-space gas volume to tidal gas volume, oxygen uptake, carbon dioxide output, Borg scale, percutaneous oxygen saturation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Control
Interventions/Control_2
Therapeutic electrical stimulation
Interventions/Control_3
Feedback
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Out patients with COPD
Key exclusion criteria
1, Orthopedic disease
2, Cardiovascular disease
3, A communication disorder
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Ito |
Organization
Osaka prefecture university
Division name
School of comprehensive rehabilitation
Zip code
Address
3-7-30, Habikino, Habikino-shi, Osaka
TEL
072-950-2874
itok@rehab.osakafu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Ito |
Organization
Osaka prefecture university
Division name
School of comprehensive rehabilitation
Zip code
Address
3-7-30, Habikino, Habikino-shi, Osaka
TEL
072-950-2874
Homepage URL
itok@rehab.osakafu-u.ac.jp
Sponsor or person
Institute
Osaka prefecture university
Institute
Department
Personal name
Funding Source
Organization
Osaka prefecture university
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
| 2013 | Year | 11 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 20 | 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
| 2013 | Year | 11 | Month | 19 | Day |
Last modified on
| 2013 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014437
