UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017991 |
|---|---|
| Receipt number | R000020850 |
| Scientific Title | A study on psychosocial factors affecting daily physical activity in patients with chronic obstructive pulmonary disease. |
| Date of disclosure of the study information | 2015/06/22 |
| Last modified on | 2015/06/20 16:10:12 |
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Basic information
Public title
A study on psychosocial factors affecting daily physical activity in patients with chronic obstructive pulmonary disease.
Acronym
A psychosocial approach on physical activity in COPD (PAPA study)
Scientific Title
A study on psychosocial factors affecting daily physical activity in patients with chronic obstructive pulmonary disease.
Scientific Title:Acronym
A psychosocial approach on physical activity in COPD (PAPA study)
Region
| Japan |
Condition
Condition
chronic obstructive lung disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify psychosocial factors which affect daily physical activity in COPD patients.
Basic objectives2
Others
Basic objectives -Others
factor analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
daily physical activity
Key secondary outcomes
acquisition of exertion habit
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
COPD with stable disease
Key exclusion criteria
1) A subject who has a severe comorbidity other than COPD
2) A subject who has disabled mobility due to extremity disfunction
3) A subject within one month after COPD exacerbation
4) A subject within one month after having systemic corticosteroids
5) A subject who cannot understand the study protocol
6) A subject who has an obvious cognition disorder.
7) A subject who is considered not apporopriate for this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohichiro Takahashi |
Organization
Faculty of Medicine, Saga University
Division name
Department of Pulmonary Medicine
Zip code
Address
Nabeshima 5-1-1 Saga, Japan
TEL
0952-3-3545
takahak@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shojiro Egoshi |
Organization
Faculty of Medicine, Saga University
Division name
Postgraduate School of Medicine
Zip code
Address
Nabeshima 5-1-1 Saga, Japan
TEL
0952-31-6511
Homepage URL
s.ego@ryokuseikan.ac.jp
Sponsor or person
Institute
NPO Hagakure Respiratory Care Network
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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）Saga University Hospital,
長生堂渡辺医院（佐賀県） Chouseido Watanabe Clinic
高邦会高木病院（福岡県） Kouhoukai Takaki Hospital
敬天堂古賀病院（佐賀県） Keitenndo Koga Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
change in daily physical activity
Management information
Registered date
| 2015 | Year | 06 | Month | 20 | Day |
Last modified on
| 2015 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020850
