UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009505 |
|---|---|
| Receipt number | R000011170 |
| Scientific Title | Preventive effect of vascular function deterioration after hemiplegic cerebral vascular accident adjustments affect activity and sleep patterns |
| Date of disclosure of the study information | 2012/12/08 |
| Last modified on | 2015/08/21 13:21:22 |
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Basic information
Public title
Preventive effect of vascular function deterioration after hemiplegic cerebral vascular accident adjustments affect activity and sleep patterns
Acronym
Vascular function of hemiplegic patients after cerebrovascular disease activity and sleep patterns
Scientific Title
Preventive effect of vascular function deterioration after hemiplegic cerebral vascular accident adjustments affect activity and sleep patterns
Scientific Title:Acronym
Vascular function of hemiplegic patients after cerebrovascular disease activity and sleep patterns
Region
| Japan |
Condition
Condition
Cerebrovascular disease
Classification by specialty
| Cardiology | Rehabilitation medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the effect of the intervention on sleep-rest activities for as long as possible to slow the deterioration of vascular function required to prevent the onset of hemiplegic patients by re-cerebrovascular disease sequelae in the maintenance phase
Basic objectives2
Others
Basic objectives -Others
In hemiplegic patients with sequelae of cerebrovascular disease that is older than two years after the onset,
To clarify the value of circadian function every 6 hours, and lower extremity venous pulse wave velocity of the left and right sides of their upper and lower extremities.
Representative value is obtained from the value of variation within, intensity and duration of physical activity per week, to clarify the amount and effect correlation between the amount of body movements during sleep and sleep duration.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Lower extremity venous function and pulse wave velocity
Key secondary outcomes
Continuous pulse wave data of physical activity during sleep, the amount of physical activity 3-axis accelerometer and heart rate, heart rate,
Depth of sleep
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 65 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
With the ability of independent walking
People with hemiplegia due to cerebrovascular disease sequelae that are older than two years from the onset
Key exclusion criteria
dementia
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira_Kimura |
Organization
Gunma_PAZ_College
Division name
Divion_of_Physical_Therapy
Zip code
Address
Tonyamachi_1-7-1,Takasaki,Gunma
TEL
+81-27-388-0865
kimuaki@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira_Kimura |
Organization
Gunma_PAZ_College
Division name
Divion_of_Physical_Therapy
Zip code
Address
Tonyamachi_1-7-1,Takasaki_Gunma
TEL
+81-27-388-0865
Homepage URL
http://kimuakilabo.main.jp/sleep_activity_CVA_vascular_study01
kimuaki@nifty.com
Sponsor or person
Institute
Kimura Akira labo, Gunma PAZ College
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nursing Home Ichiyokan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
12-16
Org. issuing International ID_1
Gunma PAZ College Research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Aonashi Nursing Home(Gunma Prefecture)
Nursing Home Ichiyokan(Gunma Prefecture)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 20 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 20 | Day |
Other
Other related information
We recruit a participant of cerebral vascular hemiplegia people by posters and oral. A venous function measuring pulse wave velocity (PWV) to measure the propagation of the left and right upper and lower extremities using folm PWV,ABI supine on a bed in the facility. In the sitting position, venous function is pasted above the Achilles tendon using an infrared sensor HS100S,HEDECO. There are allowed to proceed for 5 seconds after the contraction of the dorsiflexion bottom, and measure the time to recover to venous blood flow at rest released. These parameters are measured every 3 hours in daytime. Data measurement activities, rest, sleep, activity, a rest situation, as measures by total amount of physical activity or equivalent 3-axis accelerometer physical activity. Blood pressure and heart rate within 24 hours of continuous are measured by BPro ,Health STATS. Sleep depth is measured by HSL101,OMURON.
Management information
Registered date
| 2012 | Year | 12 | Month | 08 | Day |
Last modified on
| 2015 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011170
