The Effect of a Five Week Electrical Myostimulation Program in Chronic Diseases

Soft-hard Technologies to Assistance and Accessibility in Patients With Chronic Diseases: The Effect of a Five Week Electrical Myostimulation Program.

Patients afflicted with Chronic Heart Failure (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 primary aims of the proposed study is to: Determine the effect of a five week home based of three EMS modalities on prognostics markers, perceived quality of life, muscle force and electrical activity in subjects diagnosed with HF.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: Functional electrical stimulation; Procedure: Medium-frequency alternating current; Procedure: Burst-modulated alternating current; Procedure: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerson Cipriano Junior, PhD; Phone Number: +556181907111; Email: cipriano@unb.br

Study Locations

• Brazil
  • Federal District
    • Brasilia, Federal District, Brazil, 72220-140
      • Recruiting
      • Brasilia University
      • Contact: Gerson Cipriano Junior, PhD; Phone Number: +556181907111; Email: cipriano@unb.br
      • Contact: Laura Maria T Neves, Master; Phone Number: +5581431769; Email: lmtomazi@gmail.com
      • Principal Investigator: Gerson Cipriano Junior, PhD
      • Sub-Investigator: Laura Maria T Neves, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (1) Male or female ≥ 21 and ≤ 80 years of age.
• (2) Current HF symptoms consistent with NYHA class III-IV.
• (3) On stable HF pharmacological therapy for at least one month prior to data collection.
• (4) Left ventricular ejection fraction < 45% documented within 3 months of enrollment (obtained from subjects medical records).
• (5) No planned elective surgery or pacemaker implantation at the time of study initiation.
• (6) Hgb > 8.0 within 1 month of enrollment (obtained from subjects medical records).
• (7) Willingness to provide written informed consent.

Exclusion Criteria:

• (1) Inability to provide written informed consent.
• (2) Inability to walk on a treadmill.
• (3) Hemodynamically significant valvular heart disease.
• (4) Unstable angina.
• (5) Acute myocardial infarction within the previous 3 months.
• (6) Obstructive hypertrophic cardiomyopathy.
• (7) HF known to be secondary to pericardial disease or uncorrected valvular disease.
• (8) Chronic oxygen therapy.
• (9) Participation in another clinical trial within the past 30 days.
• (10) Participation in a regular exercise within the previous 6 months.
• (11) Previous implantation of a cardiac pacemaker or defibrillator.
• (12) Pregnancy.
• (13) Resting systolic blood pressure > 200 mmHg.
• (14) Failure to demonstrate the ability to operate the EMS unit.
• (15) Failure to be compliant with at least 75% of the EMS training sessions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional electrical stimulation; Burst modulated alternating rectified current with a 10 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts	Procedure: Functional electrical stimulation; The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction
Experimental: Medium-frequency alternating current; Burst modulated alternating current with a 2500 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts	Procedure: Medium-frequency alternating current; The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction.; Other Names: MAC
Experimental: Burst-modulated alternating current; Burst modulated alternating current with a 4000 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts.	Procedure: Burst-modulated alternating current; The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction.; Other Names: BMAC
Placebo Comparator: Placebo; Training with the intensity of 5 mA.	Procedure: Placebo; The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be fixed on 5 mA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
VE/VCO2 slope	Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS.

Secondary Outcome Measures

Outcome Measure	Time Frame
Peak VO2	Change from Baseline in Peak VO2 at five and ten weeks post EMS.
VO2 at Ventilatory Threshold	Change from Baseline in VO2 at ventilatory threshold at five and ten weeks post EMS.
Perceived quality of life	Change from Baseline in perceived quality od life at five and ten weeks post EMS.
Muscle force	Change from Baseline in muscle force at five and ten weeks post EMS.
Muscle electrical activity	Change from Baseline in muscle electrical activity at five and ten weeks post EMS.
Brain Natriuretic Peptide level	Change from Baseline in Brain Natriuretic Peptide Level at five and ten weeks post EMS.

Collaborators and Investigators

• Sponsor: University of Brasilia
• Investigators: Principal Investigator: Gerson Cipriano Junior, PhD, University of Brasilia

Publications and helpful links

General Publications

• Mueller C, Scholer A, Laule-Kilian K, Martina B, Schindler C, Buser P, Pfisterer M, Perruchoud AP. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004 Feb 12;350(7):647-54. doi: 10.1056/NEJMoa031681.
• Arena R, Myers J, Aslam SS, Varughese EB, Peberdy MA. Peak VO2 and VE/VCO2 slope in patients with heart failure: a prognostic comparison. Am Heart J. 2004 Feb;147(2):354-60. doi: 10.1016/j.ahj.2003.07.014.
• Myers J, Gademan M, Brunner K, Kottman W, Boesch C, Dubach P. Effects of high-intensity training on indices of ventilatory efficiency in chronic heart failure. J Cardiopulm Rehabil Prev. 2012 Jan-Feb;32(1):9-16. doi: 10.1097/HCR.0b013e3182343bdf.
• Vieira PJ, Chiappa AM, Cipriano G Jr, Umpierre D, Arena R, Chiappa GR. Neuromuscular electrical stimulation improves clinical and physiological function in COPD patients. Respir Med. 2014 Apr;108(4):609-20. doi: 10.1016/j.rmed.2013.12.013. Epub 2014 Jan 2.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (Estimate): September 28, 2012

Study Record Updates

• Last Update Posted (Estimate): June 10, 2013
• Last Update Submitted That Met QC Criteria: June 6, 2013
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Heart Failure; Oxygen Consumption; Transcutaneous Electric Nerve Stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Heart Failure; Chronic Disease
• Other Study ID Numbers: CSF-01