UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000046470