UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035988
Receipt No. 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 2019/02/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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.

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
Middle name
Last name Noboru Hattori
Organization Graduate School of Biomedical Sciences Hiroshima University
Division name Department of Molecular and Internal Medicine
Zip code
Address 1-2-3 Kasumi, Minami-ku Hiroshima
TEL 082-257-5196
Email nhattori@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Iwamoto
Organization Graduate School of Biomedical Sciences Hiroshima University
Division name Department of Molecular and Internal Medicine
Zip code
Address 1-2-3 Kasumi, Minami-ku Hiroshima
TEL 082-257-5196
Homepage URL
Email hir@hiroshima-u.ac.jp

Sponsor
Institute Department of Molecular and Internal Medicine
Graduate School of Biomedical Sciences Hiroshima University
Institute
Department

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
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 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
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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 25 Day
Last follow-up date
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
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040637

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.