UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003268 |
|---|---|
| Receipt number | R000003956 |
| Scientific Title | Effect of low-temperature sauna therapy for patients with chronic obstructive pulmonary disease. |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2012/03/24 17:38:22 |
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Basic information
Public title
Effect of low-temperature sauna therapy for patients with chronic obstructive pulmonary disease.
Acronym
Effect of low-temperature sauna therapy for patients with COPD
Scientific Title
Effect of low-temperature sauna therapy for patients with chronic obstructive pulmonary disease.
Scientific Title:Acronym
Effect of low-temperature sauna therapy for patients with COPD
Region
| Japan |
Condition
Condition
Chronic obstructive pulumonary disease(COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the acute effect of thermotherapy for pulumonary function in patients with COPD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Vital capacity, Forced expiratory volume in one second and Peak expiratory flow
Key secondary outcomes
Forced vital capacity , Forced expiratory flow at 50%,25% of expired FVC
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects are placed in a sitting posture in a 60 degrees-sauna for 15 min,and removed ,kept on bed rest with a blanket to keep them warm for an additional 30 min in a supine position.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with stable COPD
Key exclusion criteria
Patients with left side heart failure or COPD in acute exacerbation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kikuchi |
Organization
Misasa Medical Center,Okayama University
Division name
Division of Chronic Respiratory Disease
Zip code
Address
827Yamada,Misasa town,Tohaku country,Tottori
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kikuchi |
Organization
Misasa Medical Center,Okayama University
Division name
Division of Chronic Respiratory Disease
Zip code
Address
TEL
Homepage URL
ccjdj984@ybb.ne.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
岡山大学病院三朝医療センター(鳥取県）
Misasa Medical Center,Okayama University
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | 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
Vital capacity, Forced expiratory volume in one second and Peak expiratory flow
did not change statistically siginificantly before and after sauna therapy.
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 | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 28 | Day |
Last modified on
| 2012 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003956
