UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035988 |
|---|---|
| Receipt number | R000040637 |
| Scientific Title | Physical Activity in Patients with Bronchial Asthma: a Multicenter study |
| Date of disclosure of the study information | 2019/02/25 |
| Last modified on | 2022/02/26 09:15:17 |
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Basic information
Public title
Physical Activity in Patients with Bronchial Asthma: a Multicenter study
Acronym
Physical Activity in Bronchial Asthma
Scientific Title
Physical Activity in Patients with Bronchial Asthma: a Multicenter study
Scientific Title:Acronym
Physical Activity in Bronchial Asthma
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate physical activity in Japanese patients with bronchial asthma
Basic objectives2
Others
Basic objectives -Others
To investigate the associations of reduced physical activity with various risk factors and asthma outcomes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical activity in patients with asthma and control subjects
Key secondary outcomes
1. Severe asthma and physical activity
2. Physical activity and clinical background factors, 6-minute walk test, asthma severity, control status, exacerbation history, and inflammatory biomarkers
3. Physical activity of the elderly asthma and its related factors
4. Obese asthma and physical activity, inflammatory markers
5. HADs score, BDNF and physical activity in asthma
6. Bone mineral density in asthma, physical activity, and inflammatory markers
7. Lung CT and physical activity, respiratory function including Mostgraph
8. Spinal muscles, physical activity, myostatin
9. Risk factors for future asthma exacerbation, deterioration of respiratory function, deterioration of QOL in patients with asthma
10. Risk factors of declining physical activity over time.
11. Association of asthma phenotype and endotype with physical activity.
12. Physical activity of asthma-COPD overlap, non-smoking and smoking asthma patients.
13 Influence of COVID-19 on asthma symptoms, QOL, physical activity, and exacerbation.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with asthma
1. Patients with asthma, 20 years or older, diagnosed by a history of episodic dyspnea, wheezing, chest tightness, cough and documented reversible airflow limitation and/or airway hyperresponsiveness.
2. Clinically stable asthma for at least 6 weeks
3. Individuals who can perform spirometry
4. Individuals who gave the written informed consent before the study
Controls
1. Individuals 20 years or older without respiratory disease who gave the written informed consent
Key exclusion criteria
Patients with asthma
1. Respiratory disease other than asthma and COPD
2. Severe disease affecting walking and physical activity, such as trauma, lower limb paralysis, neurological disease, cardiovascular disease, acute infection
Controls
1. Disease affecting physical activity
2. Abnormalities in chest radiograph and spirometry (%FVC < 80%, FEV1/FVC < 0.7)
Target sample size
375
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Hattori |
Organization
Graduate School of Biomedical Sciences Hiroshima University
Division name
Department of Molecular and Internal Medicine
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku Hiroshima
TEL
082-257-5196
nhattori@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Iwamoto |
Organization
Graduate School of Biomedical Sciences Hiroshima University
Division name
Department of Molecular and Internal Medicine
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku Hiroshima
TEL
082-257-5196
Homepage URL
hir@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Molecular and Internal Medicine
Graduate School of Biomedical Sciences Hiroshima 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
1. Division of Respiratory Medicine and Infectious Disease, Graduate School of Medicine, Yamaguchi University
2. Department of Internal Medicine, Division of Medical Oncology and Respiratory Medicine, Shimane University Faculty of Medicine
3. Department of Hematology and Respiratory Medicine, Kochi Medical School, Kochi University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku Hiroshima
Tel
082-257-5907
iryo-seisaku@office.hiroshima-u.ac.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
広島大学病院（広島県）
山口大学医学部附属病院（山口県）
島根大学医学部附属病院（島根県）
高知大学医学部附属病院（高知県）
広島原爆障害対策協議会（広島県）
呉共済病院 忠海分院（広島県）
日比野病院（広島県）
国立病院機構山口宇部医療センター（山口県）
国立病院機構浜田医療センター（島根県）
すたに呼吸器内科クリニック（島根県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 25 | 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
205
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
- Study design: Multi-center, prospective, observational study
Management information
Registered date
| 2019 | Year | 02 | Month | 24 | Day |
Last modified on
| 2022 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040637
| Research Plan | |
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| 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 |
