UMIN-CTR Clinical Trial

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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