UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049837 |
|---|---|
| Receipt number | R000056766 |
| Scientific Title | A Randomized Controlled Trial for the Effectiveness of Belt Electrode Skeletal Muscle Electrical Stimulation (B-SES) Trailing |
| Date of disclosure of the study information | 2022/12/20 |
| Last modified on | 2023/08/24 12:56:39 |
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Basic information
Public title
A Randomized Controlled Trial for the Effectiveness of Belt Electrode Skeletal Muscle Electrical Stimulation (B-SES) Trailing
Acronym
A Randomized Controlled Trial for the Effectiveness of Belt Electrode Skeletal Muscle Electrical Stimulation (B-SES) Trailing (RCT-BSES)
Scientific Title
A Randomized Controlled Trial for the Effectiveness of Belt Electrode Skeletal Muscle Electrical Stimulation (B-SES) Trailing
Scientific Title:Acronym
A Randomized Controlled Trial for the Effectiveness of Belt Electrode Skeletal Muscle Electrical Stimulation (B-SES) Trailing (RCT-BSES)
Region
| Japan |
Condition
Condition
frail older adults
Classification by specialty
| Geriatrics | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of B-SES training on improving physical and cognitive functions, and to search for biomarkers containing blood that reflects these effects
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Short Physical Performance Battery (SPPB)
Key secondary outcomes
At enrollment and after 12 weeks of intervention:
Blood examination (complete blood count, biochemistry), gait speed, knee extension muscle strength, grip strength, Trail Making Test, Stroop Test, Japanese version of the Montreal Cognitive Assessment (MoCA-J), aging-related factors (GDF-15, FGF-21, Apelin, Progranulin, TNF-alpha, CXCL9, CXCL10, NAMPT, BDNF, Adiponectin, IGF-1, DHEA-S, etc), metabolome, transcriptome, adverse events, etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Belt electrode skeletal muscle electrical stimulation (B-SES) training
Interventions/Control_2
The Home Exercise Program for Older People (HEPOP)
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
Among older people aged 65 years old and over, who agreed to register for "Registry Study of Locomo-Frailty-Sarcopenia", those who met all of the following criteria
1) The Japanese version of the Cardiovascular Health Study >/= 2
2) 6-9 of the SPPB score
3) MMSE >/= 24 and MoCA-J <26
Key exclusion criteria
If persons meet even one of the following criteria, they cannot participate in this study.
1) Those who indicated their intention to refuse to participate in the study
2) Persons who are judged inappropriate for inclusion in the research by the principal investigator and co-investigator
3) Persons with certification of long-term care need (long-term care level 1 or higher)
4) Decrease in ADL (Katz Index: less than 5 points)
5) Persons with hearing loss or visual impairment that interferes with daily life
6) Persons diagnosed with the following diseases: quadriplegia, major depression, dementia, intractable neurological diseases (Parkinson's disease and related diseases, amyotrophic lateral sclerosis, degenerative diseases, etc.)
7) Subjects receiving treatment with steroid drugs
8) Subjects who are undergoing treatment for malignant tumors
9) Subjects who are contraindicated for the implementation of B-SES training
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shosuke |
| Middle name | |
| Last name | Satake |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Geriatric Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture
TEL
0562-46-2311
satakes@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Shosuke |
| Middle name | |
| Last name | Satake |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Geriatric Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture
TEL
0562-46-2311
Homepage URL
satakes@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture, 474-8511, Japan
Tel
0562-46-2311
yaday@ncgg.go.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
国立長寿医療研究センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 20 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056766
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
