UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033363 |
|---|---|
| Receipt number | R000038033 |
| Scientific Title | Efficacy of nutritional and rehabilitation education for out patients with interstitial lung disesase. |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2020/01/12 18:40:42 |
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Basic information
Public title
Efficacy of nutritional and rehabilitation education for out patients with interstitial lung disesase.
Acronym
Efficacy of education for out patients with interstitial lung disesase.
Scientific Title
Efficacy of nutritional and rehabilitation education for out patients with interstitial lung disesase.
Scientific Title:Acronym
Efficacy of education for out patients with interstitial lung disesase.
Region
| Japan |
Condition
Condition
interstitial lung disease
Classification by specialty
| Pneumology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of the education by specialist team on nutirition and rehabilitation for out patients with interstital lung disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of quadriceps muscle strength after 4 months.
Key secondary outcomes
Body composition, the distance of 6 minutes walk test, calorie intake, protein intake, volume capacity and SGRQ after 4 months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatinets with interstitial lung disease followed up in our hospital.
Other inclusion criteria are below
1.%FVC 50% or more than 50 %, %DLCO 30% to 79% and FEV1/FVC 70% or more than 70% at the pulmonary fuction test performed within 1 month before inclusion.
2.Patient who have dyspnea on effort and have 1-3 points on mMRC score.
3. The distance of 6 minutes walk test to be 150m or more than 150m
Key exclusion criteria
1.Patents with underlying diseases which have possibility of restricting the rehabilitation.
2.Patients with coronary complications (unstable angina, myocardial infarction, history of percutaneous transluminal coronary angioplasty or coronary artery bypass surgery) within 1 month, or cerebrovascular event within 6 months before inclusion.
3.Patients with uncontrolled arrythmia.
4.Pregnant women or women who have possibility to be pregnant.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Tachikawa |
Organization
Kobe City Medical Center General Hospital
Division name
Respiratory Medicine
Zip code
6500047
Address
2-1-1, Minatojima-minanimachi, Chuo-ku, Japan
TEL
078-302-4321
ryotkw@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Tachikawa |
Organization
Kobe City Medical Center General Hospital
Division name
Respiratory Medicine
Zip code
6500047
Address
2-1-1, Minatojima-minanimachi, Chuo-ku, Japan
TEL
078-302-4321
Homepage URL
ryotkw@gmail.com
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kobe City Medical Centre General Hospital
Address
2-1-1, Minatojima minamimachi, Chuo-ku, Kobe, Japan
Tel
078-302-4321
rinken@kcho.jp
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
| 2018 | Year | 09 | Month | 01 | 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
20
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
| 2018 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collect the data (which can be obtained from usual practice) from medica chart.
We have patients answer SGRQ at the begining and the end of the study.
Management information
Registered date
| 2018 | Year | 07 | Month | 11 | Day |
Last modified on
| 2020 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038033
| 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 |
