UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042160 |
|---|---|
| Receipt number | R000048061 |
| Scientific Title | Long-term effects of pulmonary rehabilitation for chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2020/10/23 |
| Last modified on | 2022/04/21 10:00:30 |
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Basic information
Public title
Long-term effects of pulmonary rehabilitation for chronic obstructive pulmonary disease
Acronym
Long-term effects of pulmonary rehabilitation for chronic obstructive pulmonary disease
Scientific Title
Long-term effects of pulmonary rehabilitation for chronic obstructive pulmonary disease
Scientific Title:Acronym
Long-term effects of pulmonary rehabilitation for chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of prevention of Chronic Obstructive Pulmonary Disease exacerbations with and without outpatient pulmonary rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of exacerbations of chronic obstructive pulmonary disease
Key secondary outcomes
Pulmonary function
Resting oxygen flow rate
Number of visits to the hospital
Body Mass Index
Co-morbidities
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Chronic Obstructive Pulmonary Disease patients who have been on continuous outpatient respiratory rehabilitation for at least 12 months between January 1, 2013 and December 31, 2019.
2. Chronic Obstructive Pulmonary Disease patients who had 12 or more regular visits between January 1, 2019 and December 31, 2019, regardless of when the outpatient visit began.
Key exclusion criteria
Patients in need of support or care
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Suzuki |
Organization
Jobu Hospital for Respiratory Diseases
Division name
Department of Rehabilitation
Zip code
371-0048
Address
586-1,Taguchi,Maebashi,Gunma,JAPAN
TEL
027-232-5000
m13204010@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Suzuki |
Organization
Jobu Hospital for Respiratory Diseases
Division name
Department of Rehabilitation
Zip code
371-0048
Address
586-1,Taguchi,Maebashi,Gunma,JAPAN
TEL
027-232-5000
Homepage URL
m13204010@gunma-u.ac.jp
Sponsor or person
Institute
Jobu Hospital for Respiratory Diseases
Institute
Department
Personal name
Funding Source
Organization
Jobu Hospital for Respiratory Diseases
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
Jobu Hospital for Respiratory Diseases
Address
586-1,Taguchi,Maebashi,Gunma,JAPAN
Tel
027-232-5000
Ichiyokai-jkn@mvd.biglobe.ne.jp
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
医療法人一羊会 上武呼吸器科内科病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 23 | 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
93
Results
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
| 2020 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 10 | Month | 19 | Day |
Last modified on
| 2022 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048061
