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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | minor ischemic stroke | |
Classification by specialty |
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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 |
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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 |
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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. |
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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 |
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Age-upper limit |
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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. |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |