UMIN-CTR Clinical Trial

Basic information
Public title	Development of physical activity improvement program for patients with minor ischemic stroke -Verification of intervention effects to reduce sedentary behavior-
Acronym	Development of physical activity improvement program for patients with minor ischemic stroke
Scientific Title	Development of physical activity improvement program for patients with minor ischemic stroke -Verification of intervention effects to reduce sedentary behavior-
Scientific Title:Acronym	Development of physical activity improvement program for patients with minor ischemic stroke
Region	Japan

Condition
Condition	minor ischemic stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to clarify whether interventions focused on reducing sedentary behavior to improve physical activity in patients with minor ishemic stroke may reduce sitting behavior and improve physical activity It is to make.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	Sedentary behavior time
Key secondary outcomes	physical activity level Low intensity activity moderate to vigorous intensity activity Self efficacy physical activity GDS-S-J JPSQI K6 6 minutes walking distance 30- second chair stand test

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group When hospitalized Physical activity instruction will be given twice for a total of 20 minutes. Education and goal setting to reduce sedentary behavior Screen time check table description / feedback using check table After discharge Until 3 months after discharge Monitoring by activity meter, check table of screen time, telephone feedback (once every 2 weeks) until 3 months after discharge
Interventions/Control_2	Control group When hospitalized At the time of admission, physical activity guidance is given twice for a total of 20 minutes. Education using pamphlets to improve physical activity, monitoring with activity meters, and feedback using checklists. After discharge Continue until 3 months after discharge. Only monitoring with an activity meter.
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	51 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Continuous cases judged by the attending physician as diagnosis of ischemic stroke , hospitalized at our hospital, acute treatment, and judged that the doctor can communicate
Key exclusion criteria	Those who did not obtain consent of research. National Institute of Health Stroke Scale (NIHSS)6 points or more. Mini-Mental State Exmination(MMSE)Less than 24points. A person who withdrew consent of research and hoped to stop research. Those who had deteriorated neurological symptoms during hospitalization and had NIHSS 6points or more. Those who do not leave home directly. Person who needed hospitalization for the same disease,other disease after discharge from home.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Ashizawa
Organization	General hospital Seirei Mikatahara Hospital
Division name	Rehabilitation department
Zip code	433-8558
Address	Shizuoka prefecture Hamamatsu city Kita-ku Mikatahara-cho 3453
TEL	053-436-1251
Email	19dr01@g.seirei.ac.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Ashizawa
Organization	General hospital Seirei Mikatahara Hospital
Division name	Rehabilitation department
Zip code	433-8558
Address	Shizuoka prefecture Hamamatsu city Kita-ku Mikatahara-cho 3453
TEL	053-436-1251
Homepage URL
Email	19dr01@g.seirei.ac.jp

Sponsor
Institute	General hospital Seirei Mikatahara Hospital
Institute
Department

Funding Source
Organization	none
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	Seirei mikatahara byouin rinnri iinnkai
Address	3453,mikataharacho,kitaku,hamamatsyshi,shizuoka
Tel	053-436-1251
Email	mk-rinri@sis.seirei.or.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	聖隷三方原病院(静岡県)

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 01 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 12 Month 01 Day
Date of IRB	2019 Year 11 Month 10 Day
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 18 Day
Last modified on	2020 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044013

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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