Electrical Muscle Stimulation in Severely Deconditioned Congestive Heart Failure Patients- a Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Difference in 6 minutes walking distance after EMS training
研究概览
简要总结
This trial is to evaluate two types of electrical muscle Stimulation (EMS) stimulation (low intensity "conventional stimulation" vs. high intensity "Russian" stimulation) of legs in comparison with a control group without EMS in a cohort of elderly patients with severe deconditioning after CHF decompensation.
详细描述
BACKGROUND:
Congestive heart failure (CHF) is increasingly prevalent worldwide and is associated with significant morbidity and mortality. Poor exercise capacity is well known as a risk factor for poor prognosis. The deconditioning is mainly associated with a decrease in leg muscle mass and loss of leg strength as well as loss of muscle endurance. This affects especially elderly patients. To improve this condition in CHF electrical muscle stimulation (EMS) is a suitable method of training, which hardly affects the heart. However, most EMS existing stimulation protocols are uncomfortable and not user-friendly, especially for elderly patients. The Russian space medicine has many years' experience in specific EMS stimulation protocols, which are well tolerated by cosmonauts for hours even during working activities. Therefore, a research project has been established between the Russian Academy of Sciences (Laboratory for Biomedical Problems) and the ARTORG Research Center for Biomedical Engineering to study the effects of new developed EMS procedures in elderly persons.
Aims:
The aim of trial is to evaluate two types of EMS stimulation (low intensity "conventional stimulation" vs. high intensity "Russian" stimulation) of legs in comparison with a control group without EMS in a cohort of elderly patients with severe deconditioning after CHF decompensation.
METHOTOLOGY:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 60 years
- •hospitalized due to heart failure
- •left ventricular ejection fraction ≤ 40%
- •NYHA class II to IV
- •willingness to complete the 6-week EMS training programme
- •tolerability of the electrical stimulation
- •provision of informed consent
排除标准
- •severe neuromuscular or oncologic diseases with inability to perform exercise testing and EMS training
- •inotropic intravenous agents used (≤10 days)
- •implanted pacemaker/ICD
- •unstable angina
- •severe uncontrolled arrhythmias
- •patients with severe pulmonary limitation (Tiffeneau ratio <70%, or vital capacity <70% of predicted value)
结局指标
主要结局
Difference in 6 minutes walking distance after EMS training
时间窗: 2 years
The primary outcome of the study is the difference in 6 minutes walking distance (m) between baseline and after 6-weeks EMS training in all groups (high intensity vs low intensity vs control).
次要结局
未报告次要终点
研究者
Nisha Arenja
Principle Investigator
Kantonsspital Olten