UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038073 |
|---|---|
| Receipt number | R000039800 |
| Scientific Title | Exploratory study of flail prevention with ankle weight (AW) --Preliminary vertifiate examination and problem extraction in mounting |
| Date of disclosure of the study information | 2019/09/21 |
| Last modified on | 2020/10/13 14:38:59 |
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Basic information
Public title
Exploratory study of flail prevention with ankle weight (AW) --Preliminary vertifiate examination and problem extraction in mounting
Acronym
Exploratory study of flail prevention
Scientific Title
Exploratory study of flail prevention with ankle weight (AW) --Preliminary vertifiate examination and problem extraction in mounting
Scientific Title:Acronym
Exploratory study of flail prevention
Region
| Japan |
Condition
Condition
Healty volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aanlysis of flail prevention by fitting ankle weight in middle aged and older age between mounting(intervention) group and non-mounting.
And extraction of problems in mounting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
motor function
By the comparison between the two groups (intervention group vs. non-intervention group) of the mean value of the duration (seconds) by single feet standing test with eye opning after the intervention (6 weeks).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
In the intervention group, they can mount Ankle wight by their free will and record the installation time and the activity situation in the diary note. And wright down resistance to fit and health damage after fitting in the diary note and extract problems.
Interventions/Control_2
The control group does not wear ankle weight, only wear pedometer, and describe daily activities in the diary note.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who gathered to recruit volunteers by calling for areas, companies, administrative staff, facility residents, etc.
2) Motor Fitness Scale scores more than 60% of 14 points
3) Those who can wear a pedometer for 14 weeks and accurately respond to inquiries
4) A person who became an ankle weight intervention group selects its weight by self-responsibility, who can receive an activity description in the diary note every day through the wearing period of 6 weeks
5) Person who obtained document agreement from himself / herself
Key exclusion criteria
1) Young people under the age of 50
2) Possible pregnancy or pregnancy
3) The person whome the Muscle strengthening agent used for doping etc., male hormone preparation, adult cortical hormone preparation in use (local topical application is not applicable)
4) MFS score is less than 60% of 14 points
5) Those who have spontaneous pain and exercise pain at the discretion of a doctor by listening to the presence or absence of joint pain, muscle pain, such as back pain / knee joint pain at the hearing
6) Those who have problems with radiation exposure (radiation exposure) for CT examination applicants (voluntary)
7) Others who judged that the research director is inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Akatsu |
Organization
Nagoya City University
Division name
Department of Medicine for Community-Based MedicalEducation, Graduate School of Medical Sciences,
Zip code
4678601
Address
1-Azakawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8537
akatu@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Emiko |
| Middle name | |
| Last name | Yoshino |
Organization
Nagoya City University Hospital
Division name
Community-based Integrated Care System Promotion and Research Center
Zip code
4678601
Address
1-Azakawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8536
Homepage URL
yoshino@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Center
Address
Aza-Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya
Tel
052-853-7215
ctmc@med.nagoya-cu.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
名古屋市立大学 鳴子CHCセンター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 21 | 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 | 10 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 21 | Day |
Last modified on
| 2020 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039800
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