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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024645
Receipt No. R000028350
Scientific Title Research for the mechanism of psychological symptom in COPD focused on brain network
Date of disclosure of the study information 2016/10/31
Last modified on 2016/11/08

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Basic information
Public title Research for the mechanism of psychological symptom in COPD focused on brain network
Acronym Research for the mechanism of psychological symptom in COPD focused on brain network
Scientific Title Research for the mechanism of psychological symptom in COPD focused on brain network
Scientific Title:Acronym Research for the mechanism of psychological symptom in COPD focused on brain network
Region
Japan

Condition
Condition COPD
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1.To confirm the presence or absence of the specific brain network disorder in patients with COPD.
2.To determine whether it is associated with psychological symptoms and physical dysfunction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relationship of the specific brain network disorders and the psychological disorders in COPD
Key secondary outcomes Relationship of the specific brain network disorders and the physical dysfunction in COPD

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 Patients will be eligible for inclusion in this study if all of the following criteria are met:

1.Patients are stable for at least 4 weeks prior to this study.
2.Patients received an explanation of the study protocol and gave written informed consent.
3.Patients are regardless of inpatients or outpatients.

Subjects will be eligible for inclusion in this study if all of the following criteria are met:

1.Subjects received an explanation of the study protocol and gave written informed consent.
Key exclusion criteria A patient will be excluded in this study if any of the folloing criteria exist.

1.Patients have had an exacerbation for 4 weeks prior to this study and have been changed therapeutic strategy in stable status.
2.Poor medication adherence in patients exist in stable status.
3.Patients have the factors that affect walking and physical activity, such as trauma or lower limb paralysis.
4.Patients are inadequate to be included in this study. (Ex: complication of malignant tumor)
5.Patients who have complicated with extra-moderate mental retardation and neurological disorders.
6.Patients wearing the implantable device in the body, such as heart pacemakers, artificial joints and joint plates and bolts of the fracture site that could be affected by a magnetic field and high-frequency electromagnetic wave.
7.Patients with claustrophobia.
8.Patients with auditory abnormalities.

Subjects will be excluded in this study if any of the following criteria.

1.Subjects have the factors that affect walking and physical activity, such as trauma or lower limb paralysis.
2.Subjects are inadequate to include in this study. (Ex: complication of malignant tumor)
3.Subjects with claustrophobia.
4.Subjects with auditory abnormalities.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuto Matsunaga
Organization Graduate School of Medicine, Yamaguchi University
Division name Respiratory Medicine and Infectious Disease
Zip code
Address 1-1-1 Minami-kogushi, Ube, 755-8505, Japan
TEL 0836-85-3123
Email kazmatsu@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsunahiko Hirano
Organization Yamaguchi University Hospital
Division name Respiratory Medicine and infectious Disease
Zip code
Address 1-1-1 Minami-kogushi, Ube, 755-8505, Japan
TEL 0836-85-3123
Homepage URL
Email tsuna@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Hospital
Respiratory Medicine and Infectious Disease
Institute
Department

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
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 山口大学医学部附属病院(山口県)、 セントヒル病院(山口県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 31 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
2016 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case-referent study
Recruit subjects by posters

Management information
Registered date
2016 Year 10 Month 31 Day
Last modified on
2016 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028350

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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