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Investigation of the Usefulness of Belt Electrode Skeletal Muscle Electrical Stimulation for Home Use

Investigation of the Usefulness of Belt Electrode Skeletal Muscle Electrical Stimulation for Home Use in Patients with Frailty or at High Risk of Frailty:A Randomized Crossover Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042240014
Enrollment
24
Registered
2024-04-11
Start date
2024-07-29
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

Frailty

Interventions

Intervention Period:Subjects will use ZB-SES for 30 minutes (20Hz) once a day, at least 4 times a week for 6 weeks.The subjects are placed at home in a supine or seated position with belt electrodes w

Sponsors

Watanabe Tsuyoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Those who are visitting outpatient clinic of locomo-Frail or orthopedics 2) Men and women over 65 years old 3) Those who can walk to the hospital by themselves (Canes are allowed.) 4) Those who meet the physical activity items of the J-CHS standards or Those who meet at least 2 items in the J-CHS criteria 5) Those who have agreed to participate in this study

Exclusion criteria

Exclusion criteria: 1) Persons with implantable electronic devices (e.g., pacemakers) 2) Persons with suspected dementia (MMSE-J score of 23 or less) and no support person to operate and manage the ZB-SES 3) Those who are scheduled to receive additional rehabilitation interventions during the study period 4) Those who are participating in other intervention studies 5) Those within 6 months after artificial joint surgery 6) Those who are deemed inappropriate for inclusion in the study by the principal investigator or co-investigator 7) Persons with skin diseases or wounds at the site where the belt electrodes are applied 8) Persons with malignant neoplasms or other diseases that may affect the efficacy and safety evaluation

Design outcomes

Primary

MeasureTime frame
SPPB

Secondary

MeasureTime frame
Physical function evaluation: SPPB(Day22) Isometric knee extensor strength(Day22,Day43) Gait indices of WalkWay, a seat-type lower limb load meter: gait speed, stride length Stand-up indices of the zaRitz motor function analyzer: F/W, RFD/W, Vx/ Vw Single-leg standing time with eyes open TUG Grip strength Locomotive syndrome risk test (stand-up test, two-step test, 25-question geriatric locomotive function scale) Body composition evaluation (BIA method): Limb skeletal muscle mass, SMI, Phase Angle Imaging evaluation (skeletal muscle evaluation by CT of the mid-thigh): muscle cross-sectional area, CT value, muscle to fat ratio,Muscle and Fat Percentage Frailty assessment: J-CHS, Kihon Checklist Geriatric Depression Scale-15 (GDS15) Safety evaluation: biochemical tests (CK), immunoserology tests (CRP)

Contacts

Public ContactYasumoto Matsui

National Center for Geriatrics and Gerontology

matsui@ncgg.go.jp+81-562-46-2311

Outcome results

None listed

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