Electrical Muscle Stimulation in Congestive Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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: This prospective, randomized controlled study will use commercially available electronic stimulator devices (Medel GmbH, Hamburg, Germany) for EMS. For the Russian stimulation, an especial developed stimulator (Amplidin-EST No.5) will be used for frequency modulation of the stimulation impulse, which is supposed to make stimulation sensation more comfortable. Supervised EMS training will be performed 5 times per week (weekdays) during 30 minutes over a period of 6 weeks in elderly deconditioned CHF patients, starting at the Kantonsspital Olten during the hospitalisation and continued at home. We will include 20 patients in each group (20 in control group, 20 in low intensity conventional group and 20 in high intensity Russian group). The control group was preformed to exclude an attention bias in the study results. The primary endpoint of the study is the difference in maximum oxygen uptake (peak VO2) and in 6 minutes walking distance between baseline and after 6-weeks EMS training in all groups (high intensity vs low intensity vs control). The follow-up period is planned for 2 years. POTENTIAL SIGNIFICANCE: Exercise capacity and quality of life in severely deconditioned patients with CHF is poor and life expectancy is low. While the possibilities to improve the poor condition and function of the heart by pharmaceutical therapies are limited, there is potential to improve the condition of the peripheral muscles by exercise training. However, a successful aerobic training is rarely feasible in these patients. Therefore, EMS training may prove to be ideal tool to improve leg muscle mass and function of elderly patients. Because, CHF patients do not tolerate most of the existing EMS stimulation protocols, we have developed a new EMS stimulation protocol. The application is virtually painless and therefore well tolerated over hours due to a sophisticated stimulation protocol. Therefore, we hope that, this especial for elderly CHF patients developed training protocol, may improve their daily activity as well as their quality of life.

Official Title
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Electrical Muscle Stimulation in Severely Deconditioned Congestive Heart Failure Patients- a Prospective, Randomized, Controlled Trial

Conditions
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Congestive Heart Failure, Electric Muscle Stimulation, Severe Decondition, Elderly Person, Exercise Capacity, Activities of Daily Living

Intervention / Treatment
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* Device: Electrical muscle devise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Intensity EMS<br>Conventional Stimulation | Device: Electrical muscle devise<br>* evaluate two types of EMS stimulation of legs<br>|
| Experimental: High Intensity EMS<br>Russian Stimulation | Device: Electrical muscle devise<br>* evaluate two types of EMS stimulation of legs<br>|
| Placebo Comparator: Placebo<br>no Stimulation, supported by phone contact | Device: Electrical muscle devise<br>* evaluate two types of EMS stimulation of legs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in 6 minutes walking distance after EMS training | 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). | 2 years |