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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Chronnic obstructive pulmonary disease(COPD) | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |