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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029518
Receipt No. R000033718
Scientific Title The analysis of related factors of physical activity in patients with COPD
Date of disclosure of the study information 2017/10/12
Last modified on 2019/11/14

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Basic information
Public title The analysis of related factors of physical activity in patients with COPD
Acronym The analysis of related factors of physical activity in COPD
Scientific Title The analysis of related factors of physical activity in patients with COPD
Scientific Title:Acronym The analysis of related factors 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 extract the factors that affect physical activity in patients with COPD using existing data
Basic objectives2 Others
Basic objectives -Others exploration
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The improvement factors of physical activity
Key secondary outcomes

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
90 years-old >
Gender Male and Female
Key inclusion criteria 1)FEV1.0/FVC<0.7
2)Patients who participated in the past in research on physical activity
Key exclusion criteria 1)Exacerbation within the last 4 weeks
2)Trauma, lower limb paralysis, etc.
3)Decline in cognitive function
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Masanori
Middle name
Last name Nakanishi
Organization Wakayama Medical University
Division name Third Department of Internal Medicine
Zip code 640-8509
Address 811-1 Kimiidera Wakayama 641-8509 Japan
TEL 073-441-0619
Email masa-n@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Masanori
Middle name
Last name Nakanishi
Organization Wakayama Medical University
Division name Third Department of Internal Medicine
Zip code 641-8509
Address 811-1 Kimiidera Wakayama 641-8509 Japan
TEL 073-441-0619
Homepage URL
Email masa-n@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tohoku University Hospital
Asahikawa Medical Center
Wakayama National Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Wakayama Medical University
Address 811-1 Kimiidera Wakayama 641-8509 Japan
Tel 073-441-0619
Email masa-n@wakayama-med.ac.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 10 Month 12 Day

Related information
URL releasing protocol https://www.dovepress.com/international-journal-of-chronic-obstructive-pulmonary-disease-journal
Publication of results Published

Result
URL related to results and publications https://www.dovepress.com/international-journal-of-chronic-obstructive-pulmonary-disease-journal
Number of participants that the trial has enrolled 162
Results
One hundred sixty-two patients aged 72.3 (7.2) years and of FEV1 %pred 59.2 (22.8) % were recruited. Among the parameters, age, mMRC dyspnea scale and inspiratory capacity (IC) were detected by the stepwise method. The created standard equation was "Step count = (-0.079*[age]-1.595*[mMRC]+2.078*[IC]+18.149)3". 
Results date posted
2019 Year 11 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Stable outpatients diagnosed with COPD
Participant flow
Physical activities had been measured using a triaxial accelerometer for more than 2 weeks.
Adverse events
none
Outcome measures
Factors associated with the step count 
a multivariate linear regression equation
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 10 Month 12 Day
Date of IRB
2017 Year 10 Month 04 Day
Anticipated trial start date
2017 Year 10 Month 12 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 10 Month 12 Day
Last modified on
2019 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033718

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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