UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029186 |
|---|---|
| Receipt number | 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 13:21:33 |
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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
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
rhirabayashi0405@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Department of Respiratory Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033356
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
