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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004391
Receipt No. 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

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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
Email

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
Email ccjdj984@ybb.ne.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

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
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 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
URL(English) https://upload.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
Registered date File name

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