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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

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

Watanabe Tsuyoshi

National Center for Geriatrics and Gerontology

7-430 MorioKa-town, Obu-city, Aichi 474-8511, Japan

tswatana@ncgg.go.jp

Matsui Yasumoto

National Center for Geriatrics and Gerontology

7-430 MorioKa-town, Obu-city, Aichi 474-8511, Japan

+81-562-46-2311

matsui@ncgg.go.jp

Not Recruiting

April. 11, 2024

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

crossover assignment

treatment purpose

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

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

Both

Frailty

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 wrapped around both thighs, and the target intensity of the electrical stimulation is set to the maximum intensity without discomfort or pain.
Non-Intervention Period:Subjects will live as usual for 6 weeks.

D016330

SPPB

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)

+81-52-744-2479

Mar. 17, 2024

Yes

Provide a copy of de-identified ZB-SES data (e.g., intensity of electrical stimulation, duration of use, etc.) to HOMER ION Laboratory Co., Ltd.No data pertaining to personal information is passed on.

none