Neuromuscular Electrical Stimulation in Chronic Heart Failure Patient

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is investigate the effects of NMES in regulation of serum IL-6 and IL-15 in chronic heart failure patients who received standard inpatient cardiac rehabilitation protocol

Detailed Description
-----------------
Majority of chronic heart failure patients became intolerance of physical training that could limit activity. Recent studies reported that Neuromuscular electrical stimulation (NMES) application could increase muscle mass, oxidative enzyme, endothelial function, VO2 peak and quality of life in chronic heart failure patient. It was hypothesized that Neuromuscular Electrical Stimulation (NMES) assisted muscle contraction in chronic heart failure patients will increase the activity of myokine (Interleukin-6 and Interleukin-15), that in turn will promote exercise tolerance in this patient. the aim of this study was to investigate the effects of NMES in regulation of serum IL-6 and IL-15 in chronic heart failure patients who received standard inpatient cardiac rehabilitation protocol. Thirty chronic heart failure patients in cardiology ward that fulfilled inclusion criteria were randomized in two groups; the control group (standard inpatient cardiac rehabilitation protocol) and the intervention group (standard inpatient cardiac rehabilitation protocol and NMES). The intervention was done every day for seven days. Measurement of serum IL-6 and IL-15 were done before and after study, and analyzed by sandwich immunoassay with monoclonal antibody.

Official Title
-----------------
The Role of Neuromuscular Electrical Stimulation in Regulation of Serum IL-6 and IL-15 in Chronic Heart Failure Patients

Conditions
-----------------
Chronic Heart Failure

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: heart failure patients admitted to the hospital NYHA II-III no weakness of lower limbs stable hemodynamic, already received standard treatment based on patient condition able to follow instruction lived at Surabaya or Sidoarjo assigned the informed consent Exclusion Criteria: knee osteoarthritis with knee pain that interfere the ambulation phlebitis and active bleeding on lower limb use vasoactive drug (such as Dobutamin etc) already receive NMES before at femoris area in last 6 weeks before admission fracture of lower limb that interfere the ambulation sensory deficit at lower limb acute infection
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>standard protocol for cardiac rehabilitation | |
| Experimental: Intervention group<br>standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES) | Device: Neuromuscular electrical stimulation (NMES)<br>* NMES was placed on the quadriceps muscle of both legs<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 and IL-15 | pg/ml | before and 7th day of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NMES, IL-6, IL-15, Chronic Heart Failure