UMIN-CTR Clinical Trial

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

COPD

Classification by specialty

Pneumology

Infectious disease

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Yamaguchi University Hospital
Respiratory Medicine and Infectious Disease

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

10

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Case-referent study
Recruit subjects by posters

Registered date

2016

Year

10

Month

31

Day

Last modified on

2016

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028350