jRCTs042240014招募中不适用
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
未提供0 个研究点目标入组 24 人开始时间: 2024年7月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Crossover Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 65age 0month 0week old over 至 No limit（—）
- 性别
- All
入选标准
- •Those who are visitting outpatient clinic of locomo-Frail or orthopedics
- •Men and women over 65 years old
- •Those who can walk to the hospital by themselves (Canes are allowed.)
- •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
- •Those who have agreed to participate in this study
排除标准
- •Persons with implantable electronic devices (e.g., pacemakers)
- •Persons with suspected dementia (MMSE-J score of 23 or less) and no support person to operate and manage the ZB-SES
- •Those who are scheduled to receive additional rehabilitation interventions during the study period
- •Those who are participating in other intervention studies
- •Those within 6 months after artificial joint surgery
- •Those who are deemed inappropriate for inclusion in the study by the principal investigator or co-investigator
- •Persons with skin diseases or wounds at the site where the belt electrodes are applied
- •Persons with malignant neoplasms or other diseases that may affect the efficacy and safety evaluation
结局指标
主要结局
-
SPPB
次要结局
- SPPB(Day22)
- Isometric knee extensor strength(Day22,Day43)
- Gait indices of WalkWay
- Stand-up indices of the zaRitz motor function analyzer
- Single-leg standing time with eyes open
- TUG
- Grip strength
- Locomotive syndrome risk test
- Body composition evaluation (BIA method)
- Imaging evaluation (skeletal muscle evaluation by CT of the mid-thigh)
- Frailty assessment
- Safety evaluation: biochemical tests
- Safety evaluation: immunoserology tests
研究者
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