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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002647
Receipt No. 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

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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
Email 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
Email yoshima@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto university
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003201

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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