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


Email



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


Email

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


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(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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name