UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of six-minutes walk test(6MWT) and four meter gait test(4MGT) for stable interstitial pneumonia patient: a prospective observational study
Title of the study (Brief title)	Study of 6MWT and 4MGT for IP patient
Region	Japan

Condition
Condition	Interestitial Pneumonia(IP)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This is a prospective observational study for evaluation of the efficacy and correlation of six-minutes walk test(6MWT)and four meter gait test(4MGT), exercise capacity, muscle weakness, dyspnea, and health-related QOL score in stable Interstitial pneumonia(IP) patient.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation of 6MWT score and 4MGT score
Key secondary outcomes	Correlation of 4MGT and following items 1. Patient profile(age, sex, Height, Body weight, BMI, smoking history, Classification of IP, and treatment) 2. Patients' vital signs(pulse rate, blood pressure, respiration rate, SpO2) 3. Arterial blood gas analysis(pH, PaO2, PaCO2) 4. Pulmonary function(FVC, FEV1.0, DLCO) 5. Muscle weakness(grip, triceps) 6. Skeletal muscle mass index(SMI) 7. Total modified-Medical Reserch Council(mMRC) dyspnea scale score 8. Total St. George's Respiratory Questionaire (SGRQ) score, and each component score (symptom score, activity score, and impact score) 9. Total COPD Assessment Test(CAT) score 10. Physical Activities

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who are clinically or pathologically diagnosed Interstitial Pneumonia(IP) with the ATS/ERS criteria. 2. Patients who agree to participate in the study with the written informed consent.
Key exclusion criteria	1. Patients who diagnosed COPD or Bronchial Asthma. 2. Patients with uncontrolled cardiovascular disease, arrhythmia, or cerebrovascular disease. 3. Patients with skeletal of joint disease and cannot walk. 4. Patients with cognitive impairment or mental disorder and are regarded as impossible to answer the questionnaire of this study. 5. Patients who have experienced a IP exacerbation within the past one month. 6. Any other cases who are regarded as inadequate for the study enrollment by the investigators.
Target sample size	50

Research contact person
Name of lead principal investigator	Keisuke Tomii
Organization	Kobe City Medical Center General Hospital
Division name	Department of Respiratory Medicine
Address	2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe
TEL	078-302-4321
Email	ktomii@kcho.jp

Public contact
Name of contact person	Ryosuke Hirabayashi
Organization	Kobe City Medical Center General Hospital
Division name	Department of Respiratory Medicine
Address	2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe
TEL	078-302-4321
Homepage URL
Email	rhirabayashi0405@kcho.jp

Sponsor
Institute	Kobe City Medical Center General Hospital Department of Respiratory Medicine
Institute
Department

Funding Source
Organization	We have no funding.
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 20 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 09 Month 01 Day
Anticipated trial start date	2017 Year 10 Month 02 Day
Last follow-up date	2018 Year 02 Month 20 Day
Date of closure to data entry	2018 Year 02 Month 20 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study targets on the IP outpatients who attend to Department of Respirology Medicine at Kobe City Medical Center General Hospital, from 2017/9/1 to 2018/2/28.

Management information
Registered date	2017 Year 09 Month 19 Day
Last modified on	2018 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033356