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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039439
Receipt No. R000044963
Scientific Title Study of the effects of chronic pulmonary diseases on instrumental activities of daily living and which related factors.
Date of disclosure of the study information 2020/02/08
Last modified on 2020/02/09

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Basic information
Public title Study of the effects of chronic pulmonary diseases on instrumental activities of daily living and which related factors.
Acronym Study of the effects of chronic pulmonary diseases on instrumental activities of daily living and which related factors.
Scientific Title Study of the effects of chronic pulmonary diseases on instrumental activities of daily living and which related factors.
Scientific Title:Acronym Study of the effects of chronic pulmonary diseases on instrumental activities of daily living and which related factors.
Region
Japan

Condition
Condition chronic obstructive pulmonary disease
idiopathic interstitial pneumonias
Classification by specialty
Pneumology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effects of chronic pulmonary diseases on instrumental activities of daily living and which related factors.
Basic objectives2 Others
Basic objectives -Others To clarify the status of instrumental activities of daily living in patients with chronic pulmonary disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. instrumental activities of daily living
Key secondary outcomes 1. patient characteristics
2. pulmonary function
3. physical activity
4. physical function
5. quality of life
6. activities of daily living
7. body composition

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 Patients aged 40 years or older with routine follow-up at the research hospital due to chronic obstructive pulmonary disease or idiopathic interstitial pneumonia, regardless of severity.
Key exclusion criteria 1. Patients with acute exacerbation at regular evaluation (within the past month) .
2. Patients who have difficulty communicating at the interview and cannot fill out the questionnaire.
3. Patients who are taking psychiatric outpatients for mental illness.
4. Patients without informed consent.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Hajime
Middle name
Last name Kurosawa
Organization Tohoku University
Division name Department of Occupational Health, Graduate School of Medicine
Zip code 980-8575
Address 2-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7874
Email kurosawa-thk@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Tomoyuki
Middle name
Last name Murakami
Organization Tohoku University
Division name Department of Occupational Health, Graduate School of Medicine
Zip code 980-8575
Address 2-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7874
Homepage URL
Email tmurakami@med.tohoku.ac.jp

Sponsor
Institute Tohoku 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 Medical and Pharmaceutical University Wakabayashi Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
Tel 022-717-8006
Email med-kenkyo@grp.tohoku.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
2020 Year 02 Month 08 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 Open public recruiting
Date of protocol fixation
2019 Year 11 Month 10 Day
Date of IRB
2019 Year 11 Month 28 Day
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is observational prospective study.
We will investigate instrumental activities of daily living, patient characteristics, physical activity, physical function, pulmonary function, activities of daily living, quality of life, and body composition.

Management information
Registered date
2020 Year 02 Month 08 Day
Last modified on
2020 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044963

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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