UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059426 |
|---|---|
| Receipt number | R000067845 |
| Scientific Title | Association Between Heart Failure Stages and Skeletal Muscle Function A Cross-Sectional Study of Community Dwelling Elderly Individuals and Elderly Hospitalized Patients with Heart Failure |
| Date of disclosure of the study information | 2025/10/17 |
| Last modified on | 2025/10/16 09:40:01 |
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Basic information
Public title
Association Between Heart Failure Stages and Skeletal Muscle Function
A Cross-Sectional Study of Community Dwelling Elderly Individuals and Elderly Hospitalized Patients with Heart Failure
Acronym
Association Between Heart Failure Stages and Skeletal Muscle Function
A Cross-Sectional Study of Community Dwelling Elderly Individuals and Elderly Hospitalized Patients with Heart Failure
Scientific Title
Association Between Heart Failure Stages and Skeletal Muscle Function
A Cross-Sectional Study of Community Dwelling Elderly Individuals and Elderly Hospitalized Patients with Heart Failure
Scientific Title:Acronym
Association Between Heart Failure Stages and Skeletal Muscle Function
A Cross-Sectional Study of Community Dwelling Elderly Individuals and Elderly Hospitalized Patients with Heart Failure
Region
| Japan |
Condition
Condition
heart failure patients
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the relationship between skeletal muscle function and progression of heart failure stages in community-dwelling elderly individuals and hospitalized elderly individuals with heart failure.
Basic objectives2
Others
Basic objectives -Others
To verify whether muscle thickness and muscle echogenicity obtained from ultrasound examination correlate with skeletal muscle function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle Thickness and Muscle Brightness Assessment of the Rectus Femoris, Vastus Medialis, and Genioglossus Muscles Using an Ultrasound Device Equipped with a 10MHz Linear Probe Ultrasound Diagnostic System
Key secondary outcomes
Skeletal Muscle Mass Index
Grip Strength
Knee Extension Strength
Short Physical Performance Battery
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community dwelling elderly individuals
1.Aged 60 years or older
2.Participants in the Niigata Prefecture Murakami City Elderly Physical Fitness Testing Session jointly conducted by Murakami City and HAL Lab. from October 26 to November 4, 2024
3.Individuals who received explanations from Murakami City and HAL Lab. and provided consent for the research use (open data conversion) of the physical fitness testing session data
Elderly Heart Failure Hospitalized Patients
1.Age 60 or older at the time of consent acquisition
2.Patients who developed heart failure and received inpatient treatment and cardiac rehabilitation
3.Individuals who consented to participate in this study
Key exclusion criteria
Community dwelling elderly individuals
1.Those with missing data
Elderly individuals hospitalized for heart failure
1.Patients who were bedridden prior to hospitalization (Daily Living Independence Level [Bedridden Level] rank C or higher for disabled elderly individuals)
2.Patients with pacemakers
Target sample size
175
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Morishita |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
9608516
Address
10-6 Sakae-machi, Fukushima-city, Fukushima, Japan
TEL
0245815503
morishit@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Morishita |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
9608516
Address
10-6 Sakae-machi, Fukushima-city, Fukushima, Japan
TEL
0245815503
Homepage URL
morishit@fmu.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
10-6 Sakae-machi, Fukushima-city, Fukushima, Japan
Tel
0245815503
morishit@fmu.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
一般財団法脳神経疾患研究所附属総合南東北病院（福島）
新潟大学地域医療教育センター魚沼基幹病院(新潟)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
nothing in particular
Management information
Registered date
| 2025 | Year | 10 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067845
