UMIN-CTR Clinical Trial

Basic information
Public title	About the relation between the sarcopenia and a fall in care-needing elderly people.
Acronym	About the relation between the sarcopenia and a fall in care-needing elderly people.
Scientific Title	About the relation between the sarcopenia and a fall in care-needing elderly people.
Scientific Title:Acronym	About the relation between the sarcopenia and a fall in care-needing elderly people.
Region	Japan

Condition
Condition	The elderly people aged 65 and over who certification of needed support.
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study clarify about the characteristic of a fall and a walk by the existence of sarcopenia in care-needing elderly people.
Basic objectives2	Others
Basic objectives -Others	Surveillance study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	basic information(age,sex,history of present illness,case or medical history,a complication,nursing level),grip,10m-usually walking speed,skeletal muscle mass,characteristic of gait,fall history,lower limb muscle,MMSE,FIM
Key secondary outcomes

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	The elderly people aged 65 and over who Certification of Needed Support to whom the walk has become independent (include use of a cane).
Key exclusion criteria	1.Those for whom it is difficult to receive a biological impedance method by a cardiac pacemaker etc. 2.A person with the past of apoplexy. 3.The person under sudden trauma medical treatment. 4.The score of MMSE are a person of 21 or less points.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kato Kota
Organization	Syutaikai hospital
Division name	Home healthcare and welfare facilities
Zip code
Address	8-1, Shirokita-cho, Yokkaichi-shi, Mie-ken
TEL	059-354-1771
Email	tuusyo-syu@syutaikai.jp

Public contact
Name of contact person	1st name Middle name Last name Kato Kota
Organization	Syutaikai hospital
Division name	Home healthcare and welfare facilities
Zip code
Address	8-1, Shirokita-cho, Yokkaichi-shi, Mie-ken
TEL	059-354-1771
Homepage URL
Email	tuusyo-syu@syutaikai.jp

Sponsor
Institute	Syutaikai 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
Address
Tel
Email

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	2015 Year 10 Month 29 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	2015 Year 10 Month 19 Day
Date of IRB	2015 Year 10 Month 13 Day
Anticipated trial start date	2015 Year 10 Month 29 Day
Last follow-up date	2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Research design:cross-sectional study Method of recruiting subjects:Between October 19, 2015 - 2017 the end of March, a person who was using our facilities and outpatient rehabilitation, and those who meet the selection criteria. Measurement item:basic information,grip,10m-usually walking speed,skeletal muscle mass,characteristic of gait,fall history,lower limb muscle,MMSE,FIM

Management information
Registered date	2015 Year 10 Month 29 Day
Last modified on	2021 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022609