UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041351 |
|---|---|
| Receipt number | R000047210 |
| Scientific Title | Clinical impact of rehabilitation for pathophysiology of chronic pulmonary obstructive disease and physical activity |
| Date of disclosure of the study information | 2020/08/07 |
| Last modified on | 2020/08/07 19:28:00 |
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Basic information
Public title
Clinical impact of rehabilitation for pathophysiology of chronic pulmonary obstructive disease and physical activity
Acronym
Clinical impact of rehabilitation for pathophysiology of chronic pulmonary obstructive disease and physical activity
Scientific Title
Clinical impact of rehabilitation for pathophysiology of chronic pulmonary obstructive disease and physical activity
Scientific Title:Acronym
Clinical impact of rehabilitation for pathophysiology of chronic pulmonary obstructive disease and physical activity
Region
| Japan |
Condition
Condition
Chronic Pulmonary Obstructive Disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical impact of rehabilitation for pathophysiology of COPD and physical activity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Alteration of activity time of 2 METs after interbation of rehabilitation
Key secondary outcomes
Alternation of pulmonary function, estimated right ventricular pressure, walking distance and decline of SPO2 in 6 minutes walking test, blood eosinophil, SGRQ score, HADS score, 5 time up and down time, blood cytokines, quality of sleep, gut microbiome
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed COPD
2) Patients who are older than 40
3) Patients whose smoking history at more than 10 pack-year
4) Patients who are gotten imformed consent for paticipation of the trial.
Key exclusion criteria
1) Patients who are yonger than 40
2) Patients who have severe liver damage and renal damage
3) Patients who are pregnant
4) Patients who have activating malignant diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Tashiro |
Organization
Faculty of Medicine, Saga University
Division name
Division of Hematology, Respiratory Medicine and Oncology
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Saga 849-8501, Japan
TEL
+81-952-34-2369
si3222@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Tashiro |
Organization
Faculty of Medicine, Saga University
Division name
Division of Hematology, Respiratory Medicine and Oncology
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Saga 849-8501, Japan
TEL
+81-952-34-2369
Homepage URL
si3222@cc.saga-u.ac.jp
Sponsor or person
Institute
Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine, Saga University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Clinical research center, Saga university Hospital
Address
5-1-1 Nabeshima, Saga, Saga 849-8501, Japan
Tel
0952-34-3400
saga@esct.bvits.com
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
佐賀大学医学部附属病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 07 | 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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not in particular
Management information
Registered date
| 2020 | Year | 08 | Month | 07 | Day |
Last modified on
| 2020 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047210
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
