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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029186
Receipt No. R000033356
Scientific Title Efficacy of six-minutes walk test(6MWT) and four meter gait test(4MGT) for stable interstitial pneumonia patient: a prospective observational study
Date of disclosure of the study information 2017/09/20
Last modified on 2018/02/20

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Basic information
Public title Efficacy of six-minutes walk test(6MWT) and four meter gait test(4MGT) for stable interstitial pneumonia patient: a prospective observational study
Acronym Study of 6MWT and 4MGT for IP patient
Scientific Title Efficacy of six-minutes walk test(6MWT) and four meter gait test(4MGT) for stable interstitial pneumonia patient: a prospective observational study
Scientific Title:Acronym 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
1st name
Middle name
Last name Keisuke Tomii
Organization Kobe City Medical Center General Hospital
Division name Department of Respiratory Medicine
Zip code
Address 2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe
TEL 078-302-4321
Email ktomii@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryosuke Hirabayashi
Organization Kobe City Medical Center General Hospital
Division name Department of Respiratory Medicine
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 20 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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
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

Other
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

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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