UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038616 |
|---|---|
| Receipt number | 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 | 2022/05/22 06:39:06 |
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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
Sedentary behavior
Key secondary outcomes
physical activity level
Low intensity activity
moderate to vigorous intensity activity
screen time
Self efficacy physical activity
GDS-S-J
JPSQI
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
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
19dr01@g.seirei.ac.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
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
19dr01@g.seirei.ac.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
Completed
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
| 2022 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044013
