UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022457 |
|---|---|
| Receipt number | R000025880 |
| Scientific Title | A validation study of IPAQ Japanese version as evaluation tool of physical activity in patients with COPD |
| Date of disclosure of the study information | 2016/05/26 |
| Last modified on | 2021/11/04 09:56:25 |
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Basic information
Public title
A validation study of IPAQ Japanese version as evaluation tool of physical activity in patients with COPD
Acronym
A validation study of IPAQ Japanese version as evaluation tool of physical activity in patients with COPD
Scientific Title
A validation study of IPAQ Japanese version as evaluation tool of physical activity in patients with COPD
Scientific Title:Acronym
A validation study of IPAQ Japanese version as evaluation tool of physical activity in patients with COPD
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify a correlation between IPAQ Japanese version and physical activity measured by 3-dimension accelerometer in patients with COPD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A correlation between IPAQ Japanese version and physical activity measured by 3-dimension accelerometer.
Key secondary outcomes
1.A correlation between IPAQ Japanese version and duration of physical activity above 2.0 METs or 3.0 Mets.
2.A correlation between IPAQ Japanese version and character of patients including age, gender and pulmonary function.
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
Out-patients who have chronic obstructive pulmonary disease (COPD)
Key exclusion criteria
1. Patients who have severe complications other than COPD
2. Patients walking ability is impaired by limb dysfunction (including painful disease)
3. Patients who have experiences of exacerbation of COPD within 1 month
4. Patients who do not understand purpose or method of the study
5. Patients with dementia
6. Patients are judged not to be suitable as subjects
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Takahashi |
Organization
Saga university
Division name
Faculty of medicine, department of internal medicine, Division of respiratory medicine
Zip code
8498501
Address
5-1-1 Nabashima, Saga, Saga Prefecture
TEL
0952-34-2369
takahak@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Tanaka |
Organization
Saga university
Division name
Faculty of medicine, department of internal medicine, Division of respiratory medicine
Zip code
8498501
Address
5-1-1 Nabashima, Saga, Saga Prefecture
TEL
0952-34-2369
Homepage URL
tanakams@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga 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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee of Saga University Hospital
Address
5-1-1 Nabashima, Saga, Saga Prefecture
Tel
0952-34-3400
clinstudycenter@mail.admin.saga-u.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
佐賀大学医学部附属病院（佐賀県）
地域医療推進機構伊万里松浦病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.jrs.or.jp/jrs57/program.html
Publication of results
Published
Result
URL related to results and publications
https://www.jrs.or.jp/jrs57/program.html
Number of participants that the trial has enrolled
25
Results
PAL(Physical Activity level) was 1.66, daily steps was 3261/day, total exercise was 1083.5 METs, min. The IPAQ physical activity amount <3000 METs correlates the analytical physical activity amount with a coefficient of 0.71 (p = 0.001).
Results date posted
| 2021 | Year | 11 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of COPD patients was 75.2 years old.
Participant flow
We asked them to fill out the IPAQ questionnaire to evaluate their physical activity, and examined the correlation with the amount of physical activity actually measured by a 3-axis accelerometer.
Adverse events
None.
Outcome measures
The IPAQ physical activity amount <3000 METs correlates the analytical physical activity amount with a coefficient of 0.71 (p = 0.001).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Study design: observational study
Subjects recruitment: Out-patients with COPD visiting Saga university hospital and JCHO Imari-Matsuura hospital
Recruiting period: From June 1st 2016 to March 31st 2017
Primary endpoint: A correlation between IPAQ Japanese version and physical activity measured by 3-dimension accelerometer.
Status of study progression:
Thirty-four patients were enrolled in the study at March, 31, 2017.
Management information
Registered date
| 2016 | Year | 05 | Month | 25 | Day |
Last modified on
| 2021 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025880
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