UMIN-CTR Clinical Trial

Basic information
Public title	To mild cerebral infarction patients Verification of contents of physical activity guidance - Comparison of guidance on living activity activities and exercise guidance-
Acronym	To mild cerebral infarction patients Verification of contents of physical activity guidance - Comparison of guidance on living activity activities and exercise guidance-
Scientific Title	To mild cerebral infarction patients Verification of contents of physical activity guidance - Comparison of guidance on living activity activities and exercise guidance-
Scientific Title:Acronym	To mild cerebral infarction patients Verification of contents of physical activity guidance - Comparison of guidance on living activity activities and exercise guidance-
Region	Japan

Condition
Condition	mild cerebral infarction patient, Transient cerebral ischemic patient
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In MIS patients and TIA patients,it is to clarify whether the living activity guidance is contents of physical activity guidance that improves physical activity amount after discharge from acute phase hospital compared to exercise instruction
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Physical activity after acute phase hospital discharge
Key secondary outcomes	6-minute walk test,Chair Standing 30second,Motor self-efficacy,Physical activity self-efficacy,Lubben Social Network Scale-6,Fall history

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Living activities group Perform physical activity instruction twice at hospitalization (1 time 20 minutes) As contents of physical activity guidance, lecture on physical activity, introduction of living activities, preparation of time schedule assuming daily life after discharge, and risks and attention points at the time of physical activity implementation will be explained. We instruct them to increase their living activities.We will wear a physical activity meter for three months after discharge. After discharge from the hospital, once every two weeks, check the status of physical activity, promote physical activities through living activities.
Interventions/Control_2	exercise group Perform physical activity instruction twice at hospitalization(1 time 20 minutes) As contents of physical activity guidance,lecture on physical activity, introduction of exercise, preparation of time schedule assuming daily life after discharge, and risks and attention points at the time of physical activity implementation will be explained. We instruct them to increase their living activities.We will wear a physical activity meter for three months after discharge. After discharge from the hospital,once every two weeks,check the status of physical activity, promote physical activities through exercise.
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Continuous cases judged by the attending physician as diagnosis of cerebral infarction, TIA, 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 27points. 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. Those who are not independent on walking at discharge(3 or less modified ranin Scale). Person who needed hospitalization for the same disease,other disease after discharge from home. Those who have difficulty performing the walk test for 6 minutes due to severe motor paralysis or higher brain dysfunction.
Target sample size	50

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	17MR01@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	None
Name of secondary funder(s)	None

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	2018 Year 02 Month 24 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	Completed
Date of protocol fixation	2018 Year 02 Month 01 Day
Date of IRB	2017 Year 09 Month 01 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 02 Month 24 Day
Last modified on	2022 Year 03 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035912