UMIN-CTR Clinical Trial

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
Email	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
Email	yoshino@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039800