UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research for the mechanism of psychological symptom in COPD focused on brain network
Title of the study (Brief title)	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	Kazuto Matsunaga
Organization	Graduate School of Medicine, Yamaguchi University
Division name	Respiratory Medicine and Infectious Disease
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	Tsunahiko Hirano
Organization	Yamaguchi University Hospital
Division name	Respiratory Medicine and infectious Disease
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 06 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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