UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010514 |
|---|---|
| Receipt number | R000012297 |
| Scientific Title | Sarcopenia and dysphagia in patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2013/04/17 |
| Last modified on | 2017/04/20 13:18:44 |
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Basic information
Public title
Sarcopenia and dysphagia in patients with chronic obstructive pulmonary disease
Acronym
Sarcopenia and dysphagia in patients with chronic obstructive pulmonary disease
Scientific Title
Sarcopenia and dysphagia in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym
Sarcopenia and dysphagia in patients with chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
Patients with chronic obstructive pulmonary disease
Classification by specialty
| Medicine in general | Gastroenterology | Pneumology |
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the natural course of swallowing and pulmonary function associated with sarcopenia in patients with chronic obstructive pulmonary disease.
Basic objectives2
Others
Basic objectives -Others
morbidity
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of sarcopenia
Key secondary outcomes
1. Dysphagia and respiratory disorder
2. COPD exacerbation
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Diagnosis of COPD by respiratory specialist.
(2)Patients who are judged to be included in the study by investigator based on a preliminary clinical examination.
(3)Written Informed Consent Form prior to participation in the trial.
Key exclusion criteria
(1)Patients who are judged not to be included in the study by investigator based on a preliminary clinical examination.
(2)A history of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
(3)Not able to perform pulmonary function tests.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuma Kishi |
Organization
Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital
Division name
Department of Respiratory Medicine, Respiratory Center
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, JAPAN
TEL
03-3588-1111
kazumak@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeo Hanada |
Organization
Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital
Division name
Department of Respiratory Medicine, Respiratory Center
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, JAPAN
TEL
03-3588-1111
Homepage URL
gourouhanada@yahoo.co.jp
Sponsor or person
Institute
Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Federation of National Public Service Personnel Mutual Aid Associations Toranomon 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
| 2013 | Year | 04 | Month | 17 | 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
| 2013 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Prospective analysis of malnutrition, dysphagia, and pulmonary function.
Management information
Registered date
| 2013 | Year | 04 | Month | 17 | Day |
Last modified on
| 2017 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012297
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
