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A Randomized Controlled Trial for the Effectiveness of Belt Electrode Skeletal Muscle Electrical Stimulation (B-SES) Trailing

A Randomized Controlled Trial for the Effectiveness of Belt Electrode Skeletal Muscle Electrical Stimulation (B-SES) Trailing - A Randomized Controlled Trial for the Effectiveness of Belt Electrode Skeletal Muscle Electrical Stimulation (B-SES) Trailing (RCT-BSES)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049837
Enrollment
40
Registered
2022-12-20
Start date
2023-01-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

frail older adults

Interventions

Belt electrode skeletal muscle electrical stimulation (B-SES) training The Home Exercise Program for Older People (HEPOP)

Sponsors

National Center for Geriatrics and Gerontology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Short Physical Performance Battery (SPPB)

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactShosuke Satake

National Center for Geriatrics and Gerontology Department of Geriatric Medicine

satakes@ncgg.go.jp0562-46-2311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026