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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021358
Receipt No. R000024632
Scientific Title Effects of comobidities on physical activity in COPD
Date of disclosure of the study information 2016/03/07
Last modified on 2019/03/14

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Basic information
Public title Effects of comobidities on physical activity in COPD
Acronym Co-mobidities and physical activity in COPD
Scientific Title Effects of comobidities on physical activity in COPD
Scientific Title:Acronym Co-mobidities and physical activity in COPD
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease (COPD)
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effects of co-mobidities on physical activity in COPD
Basic objectives2 Others
Basic objectives -Others to explore risk factors
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relation between comobidities and physical activity in stable COPD
Key secondary outcomes Relation between lung function or exercise tolerance, and physical activity in stable COPD

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 diagnosis of COPD
Key exclusion criteria 1) unable to respond questionnaire
2) unable to wear a 3-axis accelerometer
3) acute exacerbation within 2 month before enrollment
4) unable to walk
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Yoshida
Organization National Hospital Organization Fukuoka Hospital
Division name Division of Respiratory Medicine
Zip code 811-1394
Address 4-39-1 Yakatabaru, Minami-ku, Fukuoka 811-1394
TEL 092-565-5534
Email yoshida.makoto.sv@mail.hosp.go.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Yoshida
Organization National Hospital Organization Fukuoka Hospital
Division name Division of Respiratory Medicine
Zip code 811-1394
Address 4-39-1 Yakatabaru, Minami-ku, Fukuoka 811-1394
TEL 092-565-5534
Homepage URL
Email yoshida.makoto.sv@mail.hosp.go.jp

Sponsor
Institute Department of pulmonary medicine, graduate school of medical & dental sciences, Kagoshima University
Institute
Department

Funding Source
Organization The Ministry of Health Labour and Welfare,
Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of pulmonary medicine, graduate school of medical & dental sciences, Kagoshima University
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Fukuoka Hospital
Address 4-39-1 Yakatabaru, Minami-ku, Fukuoka 811-1394
Tel 092-565-5534
Email yoshida.makoto.sv@mail.hosp.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 国立病院機構福岡病院/National Hospital Organization Fukuoka Hospital

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2014 Year 06 Month 25 Day
Date of IRB
2014 Year 06 Month 23 Day
Anticipated trial start date
2014 Year 11 Month 05 Day
Last follow-up date
2016 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: cross-sectional study
Subject recruitment: COPD outpatients regularly visiting National Hospital Organization Fukuoka Hosptal
Recruiting period: from 01 NOV 2014 to 31 OCT 2016
Primary endpoint: effect of comorbidities on physical activity
Secondary endpoint: effect of lung function, symptom, exacerbation history and respiratory failure on physical activity

Management information
Registered date
2016 Year 03 Month 05 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024632

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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