UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002647 |
|---|---|
| Receipt number | R000003201 |
| Scientific Title | Effect of voluntary hyperventilation on exercise tolerance and breathlessness in patients with stable chronic obstructive pulmonary disease. |
| Date of disclosure of the study information | 2009/11/01 |
| Last modified on | 2013/10/19 20:44:33 |
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Basic information
Public title
Effect of voluntary hyperventilation on exercise tolerance and breathlessness in patients with stable chronic obstructive pulmonary disease.
Acronym
Effect of voluntary hyperventilation on exercise tolerance in patients with COPD
Scientific Title
Effect of voluntary hyperventilation on exercise tolerance and breathlessness in patients with stable chronic obstructive pulmonary disease.
Scientific Title:Acronym
Effect of voluntary hyperventilation on exercise tolerance in patients with COPD
Region
| Japan |
Condition
Condition
patients with stable chronic obstructive pulmonary disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of voluntary hyperventilation during exercise in patients with stable COPD to see if they would experience less breathlessness and improve their exercise capacity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
exercise endurance time
Key secondary outcomes
SpO2
TcPCO2
PETCO2
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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 |
Interventions/Control_1
Control trials are performed during uphill walking for 15% garades with spontaneous ventilation.
Interventions/Control_2
Interventions are performed during uphill walking for 15% garades with voluntary hyperventilation.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects are stable COPD patients with GOLD stage2-4 who have heavy breathlessness which could be a main factor of activity limitation.
Key exclusion criteria
If physician in charge of the patient judge this exermination too much harmful for him or her with a prior diagnosis of other disease or dysfunction (i.e., pulmonary hypertension, chronic heart failure, neuromuscular disorder, severe osteoarthritis), we forbid him or her to participate in this exermination.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yohei Oshima |
Organization
Kyoto university hospital
Division name
Division of rehabilitation
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3571
yoshima@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Oshima |
Organization
Kyoto university hospital
Division name
Division of rehabilitation
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3571
Homepage URL
yoshima@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
Funding Source
Organization
Kyoto university
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
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 01 | 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
| 2009 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 19 | Day |
Last modified on
| 2013 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003201
