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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031461
Receipt No. R000035912
Scientific Title To mild cerebral infarction patients Verification of contents of physical activity guidance - Comparison of guidance on living activity activities and exercise guidance-
Date of disclosure of the study information 2018/02/24
Last modified on 2019/08/29

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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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 01 Day
Date of IRB
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

Other
Other related information

Management information
Registered date
2018 Year 02 Month 24 Day
Last modified on
2019 Year 08 Month 29 Day


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

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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