UMIN-CTR Clinical Trial

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
Email	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
Email	kusunose@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026880