Feasibility and Safety of Whole-Body Electromyostimulation (WB-EMS) in Frail Older People: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
Exercise in general and resistance training (RT) in particular have demonstrated positive effects on physical functioning and frailty. However, frail older people with functional impairments are among the least physically active and may have problems reaching high intensity levels. The use of special vests with integrated electrodes allows the simultaneous innervation of all large muscle groups by external electrical stimulation, inducing a high-intensity RT at low subjective effort level. This whole-body electromyostimulation (WB-EMS) may be a feasible option inducing training stimuli for functionally impaired frail older people.
This study aims at investigating the feasibility and safety of WB-EMS in frail older people with functional limitations. To explore the effects of age and functional status, young and robust old reference groups will serve as comparators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Frail people
- •Inclusion Criteria:
- •75+ years
- •able to walk 4m w/o walking aid
- •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
- •Robust people
- •Inclusion Criteria:
- •75+ years
- •no prior WB-EMS exposure
- •Exclusion Criteria:
- •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
- •Younger people
- •Inclusion Criteria:
- •18-50 years
- •no prior WB-EMS exposure
- •Exclusion Criteria:
- •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
- •pregnancy
结局指标
主要结局
Recruitment rate
时间窗: 8 weeks
measured by ratio of included/eligible participants
Perceived enjoyment measured by the Physical Activity Enjoyment Scale for Older Adults (PACES-8)
时间窗: Change from baseline to 8 weeks
The PACES-8 comprises of 8 items on a 7-point bipolar rating scale. A sum score is calculated with higher PACES scores reflecting greater levels of enjoyment.
Concentration of Myoglobin (MB)
时间窗: measured at baseline to week 1, week 3 and week 8
Concentration of MB measured in µg/l 3 hours after training
Compliance
时间窗: from baseline to 8 weeks
measured by proportion of attended training sessions
Retention rate
时间窗: at 8 weeks
measured by proportion of participants remaining in the study
Dropout rate
时间窗: from baseline to 8 weeks
measured by the proportion of participants not completing the study
Intervention engagement measured by the Hopkins Rehabilitation Engagement Scale (HRERS)
时间窗: at 8 weeks
The HRERS, reported by instructors, comprises of 5 items on a verbal rating scale from 'Never' to 'Always'. Higher scores reflect greater levels of engagement.
Concentration of Creatinkinase (CK)
时间窗: measured at baseline to week 1, week 3 and week 8
Concentration of CK measured in U/l before, 48, 72 hours after training
estimated glomerular filtration rate (eGFR)
时间窗: measured at baseline to week 1, week 3 and week 8
eGFR (creatinine clearance) measured in mL/min/1.73m² before, 48, 72 hours after training
次要结局
- Pain assessed by the Brief Pain Inventory (BPI-SF)(measured at baseline to week 1, week 3 and week 8)
- Fatigue assessed by the Brief Fatigue Inventory (BFI)(measured at baseline to week 1, week 3 and week 8)
- Rhabdomyolysis surveillance measured by a self-developed questionnaire(measured weekly)
- System usability measured by the System Usability Scale (SUS)(once at 8 weeks)
- Lower extremity functioning measured by the Short Physical Performance Battery (SPPB)(Change from baseline to 9 weeks)
- Mobility measured by the Timed up & go test (TUG)(Change from baseline to 9 weeks)
- Maximum knee/hip extension strength(Change from baseline to 9 weeks)
- Skeletal muscle mass(Change from baseline to 8 weeks)
- Concentration of Urea(measured at baseline to week 1, week 3 and week 8)
- Rate of persons with Albuminuria(measured at baseline to week 1, week 3 and week 8)
- Rate of persons with Proteinuria(measured at baseline to week 1, week 3 and week 8)
- Concentration of Sodium(measured at baseline to week 1, week 3 and week 8)
- Concentration of Cystatin C(measured at baseline to week 1, week 3 and week 8)
- Concentration of Creatinine(measured at baseline to week 1, week 3 and week 8)
- Concentration of Potassium(measured at baseline to week 1, week 3 and week 8)
- Concentration of Calcium(measured at baseline to week 1, week 3 and week 8)
- Concentration of Phosphate(measured at baseline to week 1, week 3 and week 8)