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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025459
Receipt No. R000029290
Scientific Title Creation of the standard formula of physical activity in Japanese patients with COPD.
Date of disclosure of the study information 2017/01/10
Last modified on 2019/08/06

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Basic information
Public title Creation of the standard formula of physical activity in Japanese patients with COPD.
Acronym Standard formula of physical activity in COPD
Scientific Title Creation of the standard formula of physical activity in Japanese patients with COPD.
Scientific Title:Acronym Standard formula of physical activity in COPD
Region
Japan

Condition
Condition COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To create the standard formula of physical activity in Japanese patients with COPD
Basic objectives2 Others
Basic objectives -Others exploration
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) the duration of physical activity at more than 3.0 METs
Key secondary outcomes 1) the duration of physical activity at more than 2.0 METs
2) average intensity of physical activity (METs´Żąhr at more than 3.0 METs)
3) the total steps/day
4) the duration of physical activity at 1.0-1.5 METs

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 FEV1/FVC < 0.7
Key exclusion criteria 1) patients with bronchial asthma
2) patients received oxygen therapy
3) patients with history of lung resection
4) patients with history of COPD exacerbation among 3 months before entry
5) patients whose physical activities are extremely suppressed by diseases other than COPD
Target sample size 650

Research contact person
Name of lead principal investigator
1st name Yoshiaki
Middle name
Last name Minakata
Organization National Hospital Organization Wakayama Hospital
Division name Department of Respiratory Medicine
Zip code 644-0044
Address 1138 Wada Mihama-cho, Hidaka-gun, Wakayama, 644-0044, Japan
TEL 0738-22-3256
Email minakata.yoshiaki.qy@mail.hosp.go.jp

Public contact
Name of contact person
1st name Yoshiaki
Middle name
Last name Minakata
Organization National Hospital Organization Wakayama Hospital
Division name Department of Respiratory Medicine
Zip code 644-0044
Address 1138 Wada Mihama-cho, Hidaka-gun, Wakayama, 644-0044, Japan
TEL 0738-22-3256
Homepage URL
Email minakata.yoshiaki.qy@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Wakayama Hospital
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Central review board of National Hospital Organization
Address 2-5-21 Higashigaoka, Meguro-ku, Tokyo, 152-8621, Japan
Tel 03-5712-5075
Email 700-kenkyu@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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 10 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 11 Day
Date of IRB
2016 Year 11 Month 15 Day
Anticipated trial start date
2017 Year 01 Month 10 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will compare the physical activity of Japanese patients with COPD evaluated by a triaxial accelerometer with the several factors including demographics, pulmonary function, exercise capacity, and indices of co-morbidity, and will extract the associated factors. Then we will create the formula of standard values of physical activity in COPD by using these factors.

Management information
Registered date
2016 Year 12 Month 28 Day
Last modified on
2019 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029290

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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