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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033363
Receipt No. 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 2019/01/16

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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
Middle name
Last name Mariko Kogo
Organization Kobe City Medical Center General Hospital
Division name Respiratory Medicine
Zip code
Address 2-1-1, Minatojima-minanimachi, Chuo-ku, Japan
TEL 078-302-4321
Email m_k_o_g_o@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mariko Kogo
Organization Kobe City Medical Center General Hospital
Division name Respiratory Medicine
Zip code
Address 2-1-1, Minatojima-minanimachi, Chuo-ku, Japan
TEL 078-302-4321
Homepage URL
Email m_k_o_g_o@yahoo.co.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

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
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
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
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
2019 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038033

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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