Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure

Study Overview
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Brief Summary
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This study intends to treat patient with congestive heart failure that are maximized their pharmacological treatment and at heart transplant wait list. All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks. The outcome will be assessed by the improvement in quality of life and functional capacity.

Detailed Description
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The neuromuscular electrical stimulation (NMES) has been used as adjuvant treatment in patients with end-stage congestive heart failure. Those patients are limited to perform conventional physical activity and adherence to any every day protocols frequency. The aim of this study was evaluated the effect on functional status and quality of life after NMES treatment using Russian stimulation wave solely twice a week during five weeks period in patients waiting for a heart transplant. Inclusion criteria: Age between 30 to 80 years old Congestive heart failure in NYHA class III or IV Ejection fraction lower than 35% Stable clinical status Full pharmacologic treatment Exclusion criteria: Unstable angina Ventricular arrhythmia intermittent lameness Inferior limb amputation Protocol Design: Patients at waiting list for heart transplant will be invited to participate on protocol of NMES using Russian stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec), named NMES group or sham stimulation, named control group. The NMES will be applied for 50 minutes, twice a week on both quadriceps femoral muscles during 7 weeks. The patients will be evaluated every week for distance walked during six minutes walk test (6MWT), heart rate variability, and functional status according to New York Heart Association. All patients were evaluated at the beginning and after completion of the protocol for quality of life with Minnesota Living with Heart Failure Questionnaire (LHFQ).

Official Title
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Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),
* Device: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients on waiting list for heart transplant Exclusion Criteria: patients that won't accept to participate in the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuromuscular stimulation<br>The patients will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks. | Device: stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),<br>* All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.<br>* Other names: Neuromuscular stimulation;|
| Placebo Comparator: Sham Group<br>The patients will receive very low electric muscular stimulation with a no biological or clinical effects | Device: Sham<br>* very low electric muscular stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement on distance walked in the six minute walk test |  | after 7 weeks of first inttervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement on quality of life |  | 7 weeks after first intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, heart transplant, electrical stimulation