UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029518 |
|---|---|
| Receipt number | 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 10:23:54 |
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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
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
masa-n@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
