UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004391 |
|---|---|
| Receipt number | R000005248 |
| Scientific Title | Effect of continuous low-termerature sauna therapy for patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2010/10/18 |
| Last modified on | 2012/03/24 17:38:59 |
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Basic information
Public title
Effect of continuous low-termerature sauna therapy for patients with chronic obstructive pulmonary disease
Acronym
Effect of continuous low-termerature sauna therapy for patients with COPD
Scientific Title
Effect of continuous low-termerature sauna therapy for patients with chronic obstructive pulmonary disease
Scientific Title:Acronym
Effect of continuous low-termerature sauna therapy for patients with COPD
Region
| Japan |
Condition
Condition
Chronnic obstructive pulmonary disease(COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the continuous effect of low-temperature sauna therapy for pulmonary function and exersise tolerance in patients with COPD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Vital capacity,Forced expiratory volume in one second and Peak expiratory flow
Walk distance,Max modified borg scale,minimum oxygen saturation in 6 minutes walking test
Key secondary outcomes
Forced vital capacity,Forced expiratory flow at 50%,25% of expired FVC
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
continuous low-temperature sauna therapy
Interventions/Control_2
standard therapy(drug therapy,non drug therapy)
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
Subjects are stable COPD inpatients and outpatients with GOLD stage2-4.
Key exclusion criteria
1)Patients in acute exacerbation witnin the last month.
2)Patients with left side heart failure
3)Patients who have difficulty in waliking with arteriosclerosis obliterans,kee osteoarthritis and that.
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
Divison of Chronic Respiratory Disease
Zip code
Address
827 Yamada, Misasa town,Tohaku countyr,Tottori
TEL
0858-43-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kikuchi |
Organization
Misasa Medical Center,Okayama University Hospital
Division name
Division of Chronic Respiratory Disease
Zip code
Address
827 Yamada,Misasa town,Tohaku country ,Tottori
TEL
0858-43-1211
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
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 18 | 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
During the program maximum modified Borg scale values in six-minute walk test significantly decreased in sauna group, but not decrease significantly in control group. Six-minute walk distance showed a tendency to increase in only sauna group.
FEF50 and VC in pulmonary function test significantly increased only in Waon group, but not change significantly in control group.
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
| 2010 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 15 | 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=R000005248
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
