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

JRCT ID: jRCTs042240014

Registered date:11/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Frailty
• Date of first enrollment: 29/07/2024
• Target sample size: 24
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: SPPB

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Matsui Yasumoto
• Source(s) of Monetary Support: HOMER ION Laboratory Co.,Ltd.