UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019767 |
|---|---|
| Receipt number | 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 14:04:39 |
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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
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
a-ishikawa@kkr-ta-hp.gr.jp
Sponsor or person
Institute
KKR Takamatsu Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022826
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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