UMIN-CTR Clinical Trial

Basic information
Public title	How does the COVID-19 quarantine affect physical activity levels?
Acronym	How does the COVID-19 quarantine affect physical activity levels?
Scientific Title	How does the COVID-19 quarantine affect physical activity levels?
Scientific Title:Acronym	How does the COVID-19 quarantine affect physical activity levels?
Region	Japan

Condition
Condition	Medicine in general, Gastroenterology, Hepato-biliary-pancreatic medicine Cardiology, Pneumology, Neurology, Clinical immunology, Rehabilitation medicine
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Cardiology Pneumology Neurology Clinical immunology Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the impact of COVID-19 quarantine on the physical activity of our outpatients. To clarify the factor of COVID-19 quarantine on the physical activity of our outpatients.
Basic objectives2	Others
Basic objectives -Others	To clarify the extent and factors that contribute to changes in physical activity by disease and age.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	International Physical Activity Questionnaire
Key secondary outcomes	Questionnaire of Daily Life

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	All outpatients who do not meet the key exclusion criteria to be seen at the hospital between September 1 and September 30, 2020.
Key exclusion criteria	Patients who are expected to have difficulty responding to the questionnaire due to obvious cognitive decline or impaired consciousness Patients with fever Patients seen by ambulance Patients outside of normal office hours Patients under 20 years old Patients with writing difficulties
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Keita Middle name Last name Takagawa
Organization	Jobu hospital for respiratory diseases
Division name	Department of rehabiritation
Zip code	371-0048
Address	586-1,taguchi,Maebashi,Gunma,JAPAN
TEL	027-232-5000
Email	kt.tkgw10pt@gmail.com

Public contact
Name of contact person	1st name Keita Middle name Last name Takagawa
Organization	Jobu hospital for respiratory diseases
Division name	Department of rehabiritation
Zip code	371-0048
Address	586-1,taguchi,Maebashi,Gunma,JAPAN
TEL	027-232-5000
Homepage URL
Email	kt.tkgw10pt@gmail.com

Sponsor
Institute	Jobu hospital for respiratory diseases
Institute
Department

Funding Source
Organization	Jobu hospital for respiratory diseases
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	Jobu hospital for respiratory diseases
Address	586-1,taguchi,Maebashi,Gunma,JAPAN
Tel	027-232-5000
Email	ichiyokai-jkn@mvd.biglobe.ne.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 08 Month 25 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	250
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	Completed
Date of protocol fixation	2020 Year 08 Month 26 Day
Date of IRB	2020 Year 08 Month 27 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2020 Year 09 Month 30 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 08 Month 24 Day
Last modified on	2021 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047400