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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038616
Receipt No. R000044013
Scientific Title Development of physical activity improvement program for patients with minor ischemic stroke -Verification of intervention effects to reduce sedentary behavior-
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/18

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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 physical activity
Key secondary outcomes Low intensity activity
Medium-high intensity activity
Sedentary behavior adherence
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 mk-rinri@sis.seirei.or.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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 01 Day
Date of IRB
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
2019 Year 11 Month 18 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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