The Effect of a Five Week Electrical Myostimulation Program in Heart Failure

• VE/VCO2 slope [ Time Frame: Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]
  

• Peak VO2 [ Time Frame: Change from Baseline in Peak VO2 at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]
  
• VO2 at Ventilatory Threshold [ Time Frame: Change from Baseline in VO2 at ventilatory threshold at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]
  
• Perceived quality of life [ Time Frame: Change from Baseline in perceived quality od life at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]
  
• Muscle force [ Time Frame: Change from Baseline in muscle force at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]
  
• Muscle electrical activity [ Time Frame: Change from Baseline in muscle electrical activity at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]
  
• Brain Natriuretic Peptide level [ Time Frame: Change from Baseline in Brain Natriuretic Peptide Level at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]
  

Introduction: Chronic Heart Failure (HF) patients are a significant health care burden in many countries. Patients afflicted with HF typically do not maintain stable cardiac function for the remainder of their life and consequently require continuous medical management and intermittent hospital admissions. Several investigations have demonstrated that electrical muscle stimulation (EMS) produces positive physiologic and psychological adaptations in patients with HF. However not all the EMS modalities were been evaluated on this population or not even were tested based on present recognized gold standard clinical parameters after a short period of treatment. The impact of use of low frequency (FES) and medium-frequency currents (MAC and BMAC) as EMS on the VE/VCO2 and BNP has likewise not been investigated in patients with HF.

Purposes: The primary aims of the proposed study is to: Determine the effect of a five week home based EMS modalities (a) Functional electrical stimulation (FES), (b) medium-frequency alternating current (MAC) and (c) burst-modulated medium-frequency alternating current (BMAC) training program on the VE/VCO2 slope, Brain Natriuretic Peptide (BNP) level, peak VO2, VO2 at Ventilatory Threshold (VT), perceived quality of life, muscle force and electrical activity in subjects diagnosed with HF (NYHA III and IV). Examine changes in the previously outlined outcome measurements five weeks after cessation of the EMS ((a) FES, (b) MAC and (c) BMAC) training program.

Procedures: We will recruit 40 persons (10 for each EMS modalities and 10 control subjects) diagnosed with HF. A group of control subjects will participate using a sham current. The protocol can be conceptually divided into four sections in the following chronological sequence: (1) baseline assessment (body composition by a bone densitometer X-ray Dual energy X-Ray absortometry - DXA, Resting blood pressure and heart rate, complete blood count and BNP analysis); Living with Heart Failure Questionnaire (MLWHFQ); A physician-supervised maximal aerobic exercise test using a metabolic cart (Vmax, Viasys, USA) (VO2, VE/VCO2, VT); isokinetic peak torque (Biodex System III, Isokinetic Dynamometer, Biodex Medical, Inc., Shirley, NY) and electrical activity (Miotec, Brazil), (2) five week EMS training program (bilateral quadriceps and gastrocnemius for 5 days a week for 1 hour to each muscle group with FES, MAC and BMAC training program), (3) immediate post-training assessment within 5 days of completion of the EMS training program and a (4) final analysis five weeks after cessation of the EMS training program.