UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055806 |
|---|---|
| Receipt number | R000063324 |
| Scientific Title | Effects of an Intervention to Reduce Sedentary Behavior in Patient with Minor Stroke -A Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/10/11 |
| Last modified on | 2024/11/24 22:38:08 |
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Basic information
Public title
Effects of an Intervention to Reduce Sedentary Behavior in Patient with Minor Stroke
-A Multicenter Randomized Controlled Trial
Acronym
Effects of an Intervention to Reduce Sedentary Behavior in Patient with Minor Stroke
-A Multicenter Randomized Controlled Trial
Scientific Title
Effects of an Intervention to Reduce Sedentary Behavior in Patient with Minor Stroke
-A Multicenter Randomized Controlled Trial
Scientific Title:Acronym
Effects of an Intervention to Reduce Sedentary Behavior in Patient with Minor Stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of an intervention to reduce sedentary behavior using wearable devices in patients with minor stroke in a multicenter study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sedentary behavior time 12 months after discharge from hospital
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Provide education on reducing sedentary behavior during hospitalization
Patients wear activity meters with reminders for 3 months from the time of hospitalization.
Individual feedback based on the results will be sent one month and three months after discharge.
Interventions/Control_2
Provide education on reducing sedentary behavior during hospitalization
Wear activity meters without reminder function for 2 weeks each 1 month and 3 months after discharge
Send fixed messages 1 month and 3 months after discharge
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
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed with cerebral infarction and cerebral hemorrhage by the attending physician between October 2024 and October 2026, and were admitted to Seirei Mikatahara Hospital, Hamamatsu Medical Center, Tajimi Hospital, Toyohashi Municipal Hospital, or Nagoya Red Cross First Hospital for acute stage treatment.
Key exclusion criteria
1. those with a history of mental illness
2. under 18 years of age
3. National Institute of Health Stroke Scale (NIHSS) 6 points or more.
4. those who scored less than 24 on the Mini-Mental State Examination (MMSE)
5. who have failed to give consent for the study
6. who wish to withdraw consent for the study and discontinue the study
7. who were not discharged home
8. Those whose neurological symptoms worsened during their hospital stay and whose NIHSS score was 6 or more
9. Those who have difficulty using the activity meter.
10..Those who need walking aids such as cane or silver car.
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Ashizawa |
Organization
Seirei Mikatahara General Hospital
Division name
Department of Rehabilitation
Zip code
433-8558
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu-shi, Shizuoka
TEL
0534361251
19dr01@g.seirei.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Ashizawa |
Organization
Seirei Mikatahara General Hospital
Division name
Department of Rehabilitation
Zip code
433-8558
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu-shi, Shizuoka
TEL
0534361251
Homepage URL
19dr01@g.seirei.ac.jp
Sponsor or person
Institute
Seirei Mikatahara General 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 Hospital Ethics Committee
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu-shi, Shizuoka
Tel
0534361251
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 11 | 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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 10 | Month | 11 | Day |
Last modified on
| 2024 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063324
