UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030463 |
|---|---|
| Receipt number | 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 | 2019/12/25 10:27:58 |
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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 | Kei |
| Middle name | |
| Last name | Yunoki |
Organization
Tsuyama Chuo Hospital
Division name
Department of Cardiology
Zip code
708-0841
Address
1756, Kawasaki, Tsuyama-City, Okayama, Japan
TEL
0868218111
kei.yunoki@gmail.com
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Yunoki |
Organization
Tsuyama Chuo Hospital
Division name
Department of Cardiology
Zip code
708-0841
Address
1756, Kawasaki, Tsuyama-City, Okayama, Japan
TEL
0868218111
Homepage URL
http://www.tch.or.jp/clinical_research.html
hee0409@gmail.com
Sponsor or person
Institute
Department of Cardiology, Tsuyama Chuo Hospital
Institute
Department
Personal name
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
Department of Cardiology, Tsuyama Chuo Hospital
Address
1756, Kawasaki, Tsuyama-City, Okayama, Japan
Tel
0868218111
ando11@tch.or.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
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 25 | Day |
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
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034699
