Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant

Study Overview
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Brief Summary
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Heart transplantation is the best way to treat terminal heart failure, which can improve the quality and life expectancy of patients, as well as contribute to their social and labor rehabilitation. Actually, the procedure of heart transplantation is a complex procedure that requires the coordinated work of cardiologists, cardiac surgeons, anesthetists, perfusionist, nurses, as well as the administration of medical organizations. It is known that the restriction of motor activity in patients with heart failure leads to a loss of muscle mass, as well as a decrease in its strength and endurance. In patients with heart failure, the low functional status of skeletal muscle is associated with poor prognosis, regardless of gender, age, and concomitant coronary heart disease. Optimization of drug therapy and appropriate use of resynchronization therapy can improve functional status, as can patient engagement in exercise. Although exercise is recommended as a component of heart failure management, adherence is consistently low. This is particularly troubling because exercise has great potential as a low-risk, low-cost intervention to improve functional status and quality of life while decreasing heart failure symptoms and hospitalizations in patients with heart failure. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity. In this study, we propose to use neuromuscular electrical stimulation to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.

Official Title
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Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant

Conditions
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Sarcopenia, Heart Failure, Systolic

Intervention / Treatment
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* Device: Neuromuscular electrical stimulation (NMES)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with end-stage heart disease, listed for heart transplantation already received standard treatment based on patient condition are receiving guideline recommended pharmacologic therapy able to follow protocol procedures assigned the informed consent do not regularly exercise (10 minutes or more a day of exercise most days of the week for the past week). Exclusion Criteria: UNOS 1a or 1b patients already receive NMES at femoris area in last 6 weeks before admission Patients, who have undertaken cardiac rehab within the 12 months prior to enrollment Cognitive, orthopedic or neurological disorders or other impairment which prevents accurate application of intervention or inability to provide informed consent End Stage Renal Disease Uncontrolled arrhythmia's or 3rd degree AV heart block Those with wounds over area of proper placement of electrodes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: This is a single-blinded, randomized longitudinal study design to determine if NMES will increase muscle mass and strength and improve exercise capacity and right-ventricle diastolic function in patients with advanced HF. Patients will be randomized to either intervention that includes NMES or to a control group. In order to ensure that the two groups are comparable between treatment and control, the participants will be randomized according to gender. Randomization via minimization will be used in order to avoid an unbalanced number of women in the two comparison groups due to chance. A file of the computer-generated random assignments will be kept.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Guideline recommended pharmacologic therapy | |
| Experimental: NMES group<br>standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES) | Device: Neuromuscular electrical stimulation (NMES)<br>* NMES will carried out with four-channel myostimulator Beurer EM80 (Germany). Self-adhesive electrodes locates above the quadriceps, the duration of the NMES session was 60 minutes, including 5-minute periods of warm-up and warm-down. Throughout the series, rectangular pulses with a frequency of 45 Hz will modulate. As a result, tonic contraction of these muscles will induce for 12 seconds, followed by a pause of 5 seconds. The amplitude of electrical exposure will select separately for each of the four channels until good muscle contraction (visually or by palpation) without pain. Electrical stimulation: 5-6 session per week, for 12 weeks, with 60-minuite session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in strength test (Dynamometer) from baseline to 12-weeks post EMS in EMS vs. controls | Strength Assessment will be done using a portable hand-held dynamometer (Lafayette Manual Muscle Test System 001165) | Baseline, 12 weeks after baseline | 
| Change in 6-minute walk test distance from baseline to 12-weeks post EMS in EMS vs. controls | Participants will be instructed to move as quickly as they feel safe and comfortable over the 50-meter course for 6 minutes. As per the protocol, participants will be allowed to stop and rest if necessary. | Baseline, 12 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in right ventricle diastolic function from baseline to 12-weeks post EMS in EMS vs. controls |  | Baseline, 12 weeks after baseline | 
| Change in peak oxygen consumption, measured by spiroergometry from baseline to 12 weeks post EMS in EMS vs. controls |  | Baseline, 12 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sarcopenia, neuromuscular electric stimulation, skeletal muscles, heart failure, heart transplantation listing