UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040715 |
|---|---|
| Receipt number | 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 11:44:41 |
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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
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
riha@asahih.johas.go.jp
Sponsor or person
Institute
Asahirousai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046470
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
