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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017991
Receipt No. 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

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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
Email 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
Email s.ego@ryokuseikan.ac.jp

Sponsor
Institute NPO Hagakure Respiratory Care Network
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020850

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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