UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023330 |
|---|---|
| Receipt number | R000026880 |
| Scientific Title | An observational study exploring the relationship between dyspnea and frailty in elderly outpatients with chronic respiratory diseases |
| Date of disclosure of the study information | 2016/07/26 |
| Last modified on | 2019/07/29 10:34:20 |
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Basic information
Public title
An observational study exploring the relationship between dyspnea and frailty in elderly outpatients with chronic respiratory diseases
Acronym
An observational study exploring the relationship between dyspnea and frailty in elderly outpatients with chronic respiratory diseases
Scientific Title
An observational study exploring the relationship between dyspnea and frailty in elderly outpatients with chronic respiratory diseases
Scientific Title:Acronym
An observational study exploring the relationship between dyspnea and frailty in elderly outpatients with chronic respiratory diseases
Region
| Japan |
Condition
Condition
Chronic Respiratory Diseases
Classification by specialty
| Pneumology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the association between dyspnea and frailty in aged patients with chronic respiratory diseases
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between dyspnea scale scores and frailty status.
Key secondary outcomes
Association between dyspnea scale scores and the total scores of the Kihon Checklist.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Elderly outpatients with chronic respiratory diseases
2)Patients who give written informed consent with regard to participating in this study
Key exclusion criteria
1)Patients who are unable to fulfill questionnaires
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Kusunose |
Organization
National Center for Geriatrics
and Gerontology
Division name
Department of Pulmonary Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu-shi, Aichi-ken, 474-8511, Japan
TEL
0562462311
kusunose@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Kusunose |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Pulmonary Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu-shi, Aichi-ken, 474-8511, Japan
TEL
0562462311
Homepage URL
kusunose@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics
and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics
and Gerontology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Ethics Committee of the National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho, Obu-shi, Aichi-ken, 474-8511, Japan
Tel
0562462311
yaday@ncgg.go.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
| 2016 | Year | 07 | Month | 26 | 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
| 2016 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Relationship between dyspnea and frailty defined by Fried as meeting three out of five criteria composed of unintentional weight loss, self-reported exhaustion, low grip strength, slow walking speed and low physical activity
Management information
Registered date
| 2016 | Year | 07 | Month | 26 | Day |
Last modified on
| 2019 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026880
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
