UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031461 |
|---|---|
| Receipt number | 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 | 2022/03/01 13:34:59 |
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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
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
mk-rinri@sis.seirei.or.jp
Sponsor or person
Institute
General hospital Seirei Mikatahara Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035912
