UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019767
Receipt No. R000022826
Scientific Title characteristics of body composition and physical function in patients with idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD)
Date of disclosure of the study information 2015/11/14
Last modified on 2018/12/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title characteristics of body composition and physical function in patients with idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD)
Acronym physical function in patients with idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD)
Scientific Title characteristics of body composition and physical function in patients with idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD)
Scientific Title:Acronym physical function in patients with idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD)
Region
Japan

Condition
Condition idiopathic pulmonary fibrosis
chronic obstructive pulmonary disease
Classification by specialty
Pneumology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to explore a rehabilitation program specific to IPF by comparing body composition, physical function, physical activity, nutritional intake and muscle quality between patients with IPF and those with COPD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes muscle mass, fat mass
hand grip strength, knee extension strength
exercise tolerance
gait speed
balance ability
physical activity
nutritional intake
muscle thickness, muscle echo intensity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 muscle ultrasonography once
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1.patients who are clinically diagnosed with IPF or with GOLD stage II-IV COPD
2.obtained written informed consent
Key exclusion criteria 1.patients with combined pulmonary fibrosis and emphysema or chronic respiratory disease except IPF and COPD
2.patients with low physical function due to cerebrovascular, neuromuscular and locomotor disease
3.patients with causative factors including severe edema and pacemaker or other metals in the body that influence on bioelectrical impedance analysis
4.patients with exacerbation within one month prior to enrollment
5.patients treated with oral corticosteroids
6.patients judged to be inappropriate for this study by investigators
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Ishikawa
Organization KKR Takamatsu Hospital
Division name Rehabilitation Center
Zip code
Address 4-18 Tenjinmae, Takamatsu-shi, Kagawa-ken
TEL 087-861-3261
Email a-ishikawa@kkr-ta-hp.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Isihikwa
Organization KKR Takamatsu Hospital
Division name Rehabilitation Center
Zip code
Address 4-18 Tenjinmae, Takamatsu-shi, Kagawa-ken
TEL 087-861-3261
Homepage URL
Email a-ishikawa@kkr-ta-hp.gr.jp

Sponsor
Institute KKR Takamatsu Hospital
Institute
Department

Funding Source
Organization KKR Takamatsu 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
2015 Year 11 Month 14 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 Completed
Date of protocol fixation
2015 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 12 Day
Last modified on
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022826

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.