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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030463
Receipt No. R000034699
Scientific Title Relationship of skeletal muscle mass index (SMI), mustle mass in the lower limb using bioelectrical impedance analysis and frailty status
Date of disclosure of the study information 2017/12/19
Last modified on 2017/12/19

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Basic information
Public title Relationship of skeletal muscle mass index (SMI), mustle mass in the lower limb using bioelectrical impedance analysis and frailty status
Acronym Skeletal mustle mass and frailty
Scientific Title Relationship of skeletal muscle mass index (SMI), mustle mass in the lower limb using bioelectrical impedance analysis and frailty status
Scientific Title:Acronym Skeletal mustle mass and frailty
Region
Japan

Condition
Condition Cardiovascular disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the relationship between skeletal muscle mass index (SMI), muscle mass in the lower limb measured using bioelectrical impedance analysis (BIA) and frailty status in patients with cardiovascular disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between skeletal muscle mass index (SMI), muscle mass in the lower limb measured using bioelectrical impedance analysis (BIA) and frailty status
Key secondary outcomes 1. Assessment of cut-off value, sensitivity and specificity of skeletal muscle mass index (SMI) and muscle mass in the lower limb for the diagnosis of frailty status

2. Relationship of frailty status, skeletal muscle mass index (SMI) and muscle mass in the lower limb and in-hospital episode of fall or delirium or later major adverse outcomes (all cause death and heart failure-related admission)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Measurement of skeletal muscle mass index (SMI) and muscle mass in the lower limb using bioelectrical impedance analysis (BIA) and
evaluation of frailty status using four scales (The Edmonton Frail Score, SHARE-FI, Frailty Screening Index, Clinical Frailty Scale) in hospitalized patients with cardiovascular disease
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients required hospitalization due to cardiovascular disease
Key exclusion criteria 1. Patients with pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devise

2. Inadequate patients by physician's discresion
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Yunoki
Organization Tsuyama Chuo Hospital
Division name Department of Cardiology
Zip code
Address 1756, Kawasaki, Tsuyama-City, Okayama, Japan
TEL 0868-21-8111
Email kei.yunoki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hisatoshi Mori
Organization Tsuyama Chuo Hospital
Division name Department of Cardiology
Zip code
Address 1756, Kawasaki, Tsuyama-City, Okayama, Japan
TEL 0868-21-8111
Homepage URL http://www.tch.or.jp/clinical_research.html
Email hee0409@gmail.com

Sponsor
Institute Department of Cardiology, Tsuyama Chuo Hospital
Institute
Department

Funding Source
Organization Department of Cardiology, Tsuyama Chuo Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2017 Year 12 Month 19 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
2017 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 19 Day
Last modified on
2017 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034699

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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