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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040715
Receipt No. R000046470
Scientific Title The effects of restricting going out on patients with chronic respiratory disease
Date of disclosure of the study information 2020/06/11
Last modified on 2021/06/18

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Basic information
Public title The effects of restricting going out on patients with chronic respiratory disease
Acronym The effects of restricting going out on patients with chronic respiratory disease
Scientific Title The effects of restricting going out on patients with chronic respiratory disease
Scientific Title:Acronym The effects of restricting going out on patients with chronic respiratory disease
Region
Japan

Condition
Condition Chronic Respiratory Disease
Classification by specialty
Pneumology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1)To clarify changes in physical activity and symptoms during periods of refraining from going out to prevent COVID-19 infection.
2)To clarify the difference in subjective symptoms and psychological factors related to physical activity between those who have improved physical activity after canceling the request to refrain from going out and those who do not.
3)To clarify the long-term effects of changes in physical activity after canceling the request to refrain from going out, such as the number of hospitalizations, the frequency of use of nursing care services, the severity of illness, and the prognosis.
Basic objectives2 Others
Basic objectives -Others The help for patient education such as exercise at home for patients with chronic respiratory disease corresponding to future infectious disease epidemic/urgent declaration
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes All-cause mortality at 5-, 10-year after cancellation of request to refrain from going out or 1 year after the start of research
Key secondary outcomes Number of hospitalizations for respiratory disease
Disease severity
Frequency of use of long-term care insurance service
Physical activity
Dyspnea
Stages of change
Self-efficacy for exercise
Outcome expectations for exercise
Decisional balance for exercise
Health literacy
Depression
Living space
Respiratory function test
Blood gas analysis


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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with chronic respiratory disease
Key exclusion criteria Patients who ask us not to use their clinical information.
Patients who have difficulty understanding questions due to cognitive decline
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Tomohiro
Middle name
Last name Kawaji
Organization Asahirousai Hospital
Division name Department of Rehabilitation
Zip code 488-8585
Address 61, Hirakochoukita, Owariasahi-city, Aichi, Japan
TEL 0561-54-3131
Email riha@asahih.johas.go.jp

Public contact
Name of contact person
1st name Tomohiro
Middle name
Last name Kawaji
Organization Asahirousai Hospital
Division name Department of Rehabilitation
Zip code 488-8585
Address 61, Hirakochoukita, Owariasahi-city, Aichi, Japan
TEL 0561-54-3131
Homepage URL
Email riha@asahih.johas.go.jp

Sponsor
Institute Asahirousai Hospital
Institute
Department

Funding Source
Organization Asahirousai Hospital
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 Asahirousai Hospital
Address 61, Hirakochoukita, Owariasahi-city, Aichi, Japan
Tel 0561-54-3131
Email riha@asahih.johas.go.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 06 Month 11 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 600
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 No longer recruiting
Date of protocol fixation
2020 Year 06 Month 03 Day
Date of IRB
2020 Year 06 Month 03 Day
Anticipated trial start date
2020 Year 06 Month 12 Day
Last follow-up date
2032 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
2020 Year 06 Month 10 Day
Last modified on
2021 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046470

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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