The Efficacy of Whole-Body Electromyostimulation (WB-EMS) in Frail Older People: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in Lower Extremity Functioning
研究概览
简要总结
Exercise in general and resistance training (RT) in particular have demonstrated positive effects on frailty outcomes, including physical functioning. However, frail older people with functional impairments are among the least physically active and have problems reaching high-intensity levels. Whole-body electromyostimulation (WB-EMS) allows the simultaneous innervation of all large muscle groups by external electrical stimulation, inducing a high-intensity RT at a low subjective effort level. The efficacy of WB-EMS in frail older people has yet to be determined.
The primary objective of this study is to investigate the efficacy of WB-EMS in frail older people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 65 years and older
- •frail according to Tilburg Frailty Indicator
- •residing in assisted living facility or nursing home
- •able to walk 4m w/o walking aid but without personal assistance
- •no prior WB-EMS exposure
排除标准
- •severe visual or hearing impairments
- •major cognitive impairment (MMSE <10)
- •medications with muscle-anabolic effects
- •medical conditions affecting trainability of muscles (e.g. Myasthenia gravis, Cushing syndrome, Morbus McArdle)
- •surgery within past two months
- •history of rhabdomyolysis
- •medical conditions affecting sensation of electrical stimuli (e.g. severe polyneuropathy)
- •severe renal insufficiency (eGFR<30 ml/min/1.73m²)
- •electronic implants
- •acute or untreated abdominal wall or inguinal hernia
- •Ventricular arrhythmias requiring therapy
结局指标
主要结局
Change in Lower Extremity Functioning
时间窗: 8 weeks, 16 weeks, 32 weeks
The Short Physical Performance Battery (SPPB) comprises of three dimensions, balance (static - standing in 3 positions of increasing difficulty by reducing base of support for max. 10s), gait (usual pace - two walks of 4m lengths), functional strength (chair rise - five times sit-to-stand transfers as fast as possible). A sum score is calculated (0-12 points) with higher scores indicating better functional status and each dimension being equally weighed (0-4 points).
次要结局
- Change in leg strength(8 weeks, 16 weeks, 32 weeks)
- Change in maximal hand grip strength(8 weeks, 16 weeks, 32 weeks)
- Change in concentration of total cholesterol(16 weeks)
- Change in concentration of low-density lipoprotein (LDL)(16 weeks)
- Change in concentration of glucose(16 weeks)
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(8 weeks, 16 weeks)
- Change in Mobility measured by the Timed up & go test (TUG)(8 weeks, 16 weeks, 32 weeks)
- Change in gait speed(16 weeks, 32 weeks)
- Change in lean mass(16 weeks, 32 weeks)
- Change in fat mass(16 weeks, 32 weeks)
- Change in Choice Stepping Reaction Time (CSRT) test(16 weeks, 32 weeks)
- Change in Body Sway(8 weeks, 16 weeks, 32 weeks)
- Change in Balance performance(16 weeks, 32 weeks)
- Change in Frailty Status(16 weeks, 32 weeks)
- Change in Physical Activity(16 weeks)
- Change in concentration of Triglycerides(16 weeks)
- Change in concentration of high-density lipoprotein (HDL)(16 weeks)
- Change in concentration of Creatinkinase (CK)(8 weeks, 16 weeks)
- Change in Quality of Life (QoL)(16 weeks)
- Change in Functional Balance(16 weeks, 32 weeks)
- Change in concentration of Creatinine(8 weeks, 16 weeks)
- Change in estimated glomerular filtration rate (eGFR)(8 weeks, 16 weeks)
- Change in continence status(16 weeks, 32 weeks)
- Change in depressive symptoms(16 weeks, 32 weeks)
- Change in concerns about falling(16 weeks, 32 weeks)
- Change in sarcopenia specific QoL(16 weeks, 32 weeks)
- Change in Health-related Quality of Life (HrQoL)(8 weeks, 16 weeks, 32 weeks)