UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043041 |
|---|---|
| Receipt number | R000049135 |
| Scientific Title | Effect of electromyostimulation training on age-related intramuscular fat accumulation |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2025/01/21 10:23:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of electromyostimulation training on age-related intramuscular fat accumulation
Acronym
Effect of electromyostimulation training on age-related intramuscular fat accumulation
Scientific Title
Effect of electromyostimulation training on age-related intramuscular fat accumulation
Scientific Title:Acronym
Effect of electromyostimulation training on age-related intramuscular fat accumulation
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of EMS training on the intramuscular fat content of the quadriceps femoris in older adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electromyostimulation training: 12 weeks, 3 times/week, session time: 30 min
Assessments: Blood biochemistry, ultrasonography (muscle content, intramuscular fat measurement by echo intensity), muscle strength, physical activity, dietary assessment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
electromyostimulation training
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
physically active, non-obese, independently living men and women adults
Key exclusion criteria
a history of heart disease (e.g., myocardial infarction, angina pectoris, cardiac insufficiency), cerebrovascular disease (e.g., cerebral infarction, hemorrhage), or extreme hypertension (e.g., systolic blood pressure (BP) >180 mmHg, diastolic BP >110 mmHg)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Maya |
| Middle name | |
| Last name | Hioki |
Organization
Teikyo Heisei University
Division name
Department of Physical Therapy Faculty of Health Care and Medical Sports
Zip code
290-0193
Address
4-1 Uruido Minami, Ichihara, Chiba 290-1093
TEL
0436-74-5908
m.hioki@thu.ac.jp
Public contact
Name of contact person
| 1st name | Maya |
| Middle name | |
| Last name | Hioki |
Organization
Teikyo Heisei University
Division name
Department of Physical Therapy Faculty of Health Care and Medical Sports
Zip code
290-0193
Address
4-1 Uruido Minami, Ichihara, Chiba 290-0193
TEL
0436-74-5908
Homepage URL
m.hioki@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
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
The Ethics Committee of Teikyo Heisei University
Address
4-1 Uruido Minami, Ichihara, Chiba 290-0193
Tel
0436-74-5511
rec@thu.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36260185/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36260185/
Number of participants that the trial has enrolled
19
Results
Results: EMS training did not significantly change echo intensity in muscles, muscle thickness, muscle strength, or biochemical parameters. Regarding the acute effect on blood lipid concentrations, a single-EMS session increased free fatty acid and glucose concentrations.
Results date posted
| 2025 | Year | 01 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The flowchart of the study procedures and participants was shown in CONSORT guidelines, Figure 1 (see, Hioki et al. Eur J Appl Physiol 2023).
Participant flow
The flowchart of the study procedures and participants was shown in CONSORT guidelines, Figure 1 (see, Hioki et al. Eur J Appl Physiol 2023). This study recruited participants in the age range of 60 to 80 years at four local community centers. When recruited, the exclusion criteria were shown to potential participants, and participant eligibility was assessed using a questionnaire (n=28) that resulted in the exclusion of a total of 8 participants for the following reasons: did not meet inclusion criteria (n=2) or refused to participate (n=6). Moreover, one participant was discontinued from the intervention (at the first body composition measurement). Finally, a total of 19 participants (10 men, 9 women), ranging in age from 61 to 78 years, were included in the study.
Adverse events
No
Outcome measures
The intramuscular fat content index was estimated by echo intensity of the quadriceps on ultrasonography, and muscle thickness was also measured. Muscle strength was assessed as the maximal voluntary contraction during isometric knee extension. Echo intensity, muscle thickness, and muscle strength were measured before and after EMS training. A rested/fasting blood samples were collected before and after EMS training. To examine the acute effect of a single-EMS session on biochemical parameters, blood samples were taken before and after the EMS session(Hioki et al. 2023).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 18 | Day |
Last modified on
| 2025 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049135
