<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01695421</url>
  </required_header>
  <id_info>
    <org_study_id>CSF-01</org_study_id>
    <nct_id>NCT01695421</nct_id>
  </id_info>
  <brief_title>The Effect of a Five Week Electrical Myostimulation Program in Chronic Diseases</brief_title>
  <official_title>Soft-hard Technologies to Assistance and Accessibility in Patients With Chronic Diseases: The Effect of a Five Week Electrical Myostimulation Program.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Brasilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Brasilia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients afflicted with Chronic Heart Failure (HF) typically do not maintain stable cardiac&#xD;
      function for the remainder of their life and consequently require continuous medical&#xD;
      management and intermittent hospital admissions. Several investigations have demonstrated&#xD;
      that electrical muscle stimulation (EMS) produces positive physiologic and psychological&#xD;
      adaptations in patients with HF. However not all the EMS modalities were been evaluated on&#xD;
      this population or not even were tested based on present recognized gold standard clinical&#xD;
      parameters after a short period of treatment. The primary aims of the proposed study is to:&#xD;
      Determine the effect of a five week home based of three EMS modalities on prognostics&#xD;
      markers, perceived quality of life, muscle force and electrical activity in subjects&#xD;
      diagnosed with HF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Chronic Heart Failure (HF) patients are a significant health care burden in&#xD;
      many countries. Patients afflicted with HF typically do not maintain stable cardiac function&#xD;
      for the remainder of their life and consequently require continuous medical management and&#xD;
      intermittent hospital admissions. Several investigations have demonstrated that electrical&#xD;
      muscle stimulation (EMS) produces positive physiologic and psychological adaptations in&#xD;
      patients with HF. However not all the EMS modalities were been evaluated on this population&#xD;
      or not even were tested based on present recognized gold standard clinical parameters after a&#xD;
      short period of treatment. The impact of use of low frequency (FES) and medium-frequency&#xD;
      currents (MAC and BMAC) as EMS on the VE/VCO2 and BNP has likewise not been investigated in&#xD;
      patients with HF.&#xD;
&#xD;
      Purposes: The primary aims of the proposed study is to: Determine the effect of a five week&#xD;
      home based EMS modalities (a) Functional electrical stimulation (FES), (b) medium-frequency&#xD;
      alternating current (MAC) and (c) burst-modulated medium-frequency alternating current (BMAC)&#xD;
      training program on the VE/VCO2 slope, Brain Natriuretic Peptide (BNP) level, peak VO2, VO2&#xD;
      at Ventilatory Threshold (VT), perceived quality of life, muscle force and electrical&#xD;
      activity in subjects diagnosed with HF (NYHA III and IV). Examine changes in the previously&#xD;
      outlined outcome measurements five weeks after cessation of the EMS ((a) FES, (b) MAC and (c)&#xD;
      BMAC) training program.&#xD;
&#xD;
      Procedures: We will recruit 40 persons (10 for each EMS modalities and 10 control subjects)&#xD;
      diagnosed with HF. A group of control subjects will participate using a sham current. The&#xD;
      protocol can be conceptually divided into four sections in the following chronological&#xD;
      sequence: (1) baseline assessment (body composition by a bone densitometer X-ray Dual energy&#xD;
      X-Ray absortometry - DXA, Resting blood pressure and heart rate, complete blood count and BNP&#xD;
      analysis); Living with Heart Failure Questionnaire (MLWHFQ); A physician-supervised maximal&#xD;
      aerobic exercise test using a metabolic cart (Vmax, Viasys, USA) (VO2, VE/VCO2, VT);&#xD;
      isokinetic peak torque (Biodex System III, Isokinetic Dynamometer, Biodex Medical, Inc.,&#xD;
      Shirley, NY) and electrical activity (Miotec, Brazil), (2) five week EMS training program&#xD;
      (bilateral quadriceps and gastrocnemius for 5 days a week for 1 hour to each muscle group&#xD;
      with FES, MAC and BMAC training program), (3) immediate post-training assessment within 5&#xD;
      days of completion of the EMS training program and a (4) final analysis five weeks after&#xD;
      cessation of the EMS training program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VE/VCO2 slope</measure>
    <time_frame>Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak VO2</measure>
    <time_frame>Change from Baseline in Peak VO2 at five and ten weeks post EMS.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VO2 at Ventilatory Threshold</measure>
    <time_frame>Change from Baseline in VO2 at ventilatory threshold at five and ten weeks post EMS.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived quality of life</measure>
    <time_frame>Change from Baseline in perceived quality od life at five and ten weeks post EMS.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle force</measure>
    <time_frame>Change from Baseline in muscle force at five and ten weeks post EMS.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle electrical activity</measure>
    <time_frame>Change from Baseline in muscle electrical activity at five and ten weeks post EMS.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain Natriuretic Peptide level</measure>
    <time_frame>Change from Baseline in Brain Natriuretic Peptide Level at five and ten weeks post EMS.</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Functional electrical stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Burst modulated alternating rectified current with a 10 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium-frequency alternating current</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Burst modulated alternating current with a 2500 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Burst-modulated alternating current</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Burst modulated alternating current with a 4000 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Training with the intensity of 5 mA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Medium-frequency alternating current</intervention_name>
    <description>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.</description>
    <arm_group_label>Medium-frequency alternating current</arm_group_label>
    <other_name>MAC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Burst-modulated alternating current</intervention_name>
    <description>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.</description>
    <arm_group_label>Burst-modulated alternating current</arm_group_label>
    <other_name>BMAC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>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.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Functional electrical stimulation</intervention_name>
    <description>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</description>
    <arm_group_label>Functional electrical stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) Male or female ≥ 21 and ≤ 80 years of age.&#xD;
&#xD;
          -  (2) Current HF symptoms consistent with NYHA class III-IV.&#xD;
&#xD;
          -  (3) On stable HF pharmacological therapy for at least one month prior to data&#xD;
             collection.&#xD;
&#xD;
          -  (4) Left ventricular ejection fraction &lt; 45% documented within 3 months of enrollment&#xD;
             (obtained from subjects medical records).&#xD;
&#xD;
          -  (5) No planned elective surgery or pacemaker implantation at the time of study&#xD;
             initiation.&#xD;
&#xD;
          -  (6) Hgb &gt; 8.0 within 1 month of enrollment (obtained from subjects medical records).&#xD;
&#xD;
          -  (7) Willingness to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) Inability to provide written informed consent.&#xD;
&#xD;
          -  (2) Inability to walk on a treadmill.&#xD;
&#xD;
          -  (3) Hemodynamically significant valvular heart disease.&#xD;
&#xD;
          -  (4) Unstable angina.&#xD;
&#xD;
          -  (5) Acute myocardial infarction within the previous 3 months.&#xD;
&#xD;
          -  (6) Obstructive hypertrophic cardiomyopathy.&#xD;
&#xD;
          -  (7) HF known to be secondary to pericardial disease or uncorrected valvular disease.&#xD;
&#xD;
          -  (8) Chronic oxygen therapy.&#xD;
&#xD;
          -  (9) Participation in another clinical trial within the past 30 days.&#xD;
&#xD;
          -  (10) Participation in a regular exercise within the previous 6 months.&#xD;
&#xD;
          -  (11) Previous implantation of a cardiac pacemaker or defibrillator.&#xD;
&#xD;
          -  (12) Pregnancy.&#xD;
&#xD;
          -  (13) Resting systolic blood pressure &gt; 200 mmHg.&#xD;
&#xD;
          -  (14) Failure to demonstrate the ability to operate the EMS unit.&#xD;
&#xD;
          -  (15) Failure to be compliant with at least 75% of the EMS training sessions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerson Cipriano Junior, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Brasilia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gerson Cipriano Junior, PhD</last_name>
    <phone>+556181907111</phone>
    <email>cipriano@unb.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Brasilia University</name>
      <address>
        <city>Brasilia</city>
        <state>Federal District</state>
        <zip>72220-140</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gerson Cipriano Junior, PhD</last_name>
      <phone>+556181907111</phone>
      <email>cipriano@unb.br</email>
    </contact>
    <contact_backup>
      <last_name>Laura Maria T Neves, Master</last_name>
      <phone>+5581431769</phone>
      <email>lmtomazi@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Gerson Cipriano Junior, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laura Maria T Neves, Master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>22113369</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>14760336</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>14960741</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>June 6, 2013</last_update_submitted>
  <last_update_submitted_qc>June 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 10, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Brasilia</investigator_affiliation>
    <investigator_full_name>Gerson Cipriano Jr</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Transcutaneous Electric Nerve Stimulation</keyword>
  <keyword>Oxygen Consumption</keyword>
  <keyword>Heart Failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01695421
org study id: CSF-01
nct id: NCT01695421
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: VE/VCO2 slope
time frame: Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS.
measure: Peak VO2
time frame: Change from Baseline in Peak VO2 at five and ten weeks post EMS.
measure: VO2 at Ventilatory Threshold
time frame: Change from Baseline in VO2 at ventilatory threshold at five and ten weeks post EMS.
measure: Perceived quality of life
time frame: Change from Baseline in perceived quality od life at five and ten weeks post EMS.
measure: Muscle force
time frame: Change from Baseline in muscle force at five and ten weeks post EMS.
measure: Muscle electrical activity
time frame: Change from Baseline in muscle electrical activity at five and ten weeks post EMS.
measure: Brain Natriuretic Peptide level
time frame: Change from Baseline in Brain Natriuretic Peptide Level at five and ten weeks post EMS.
arm group label: Functional electrical stimulation
arm group type: Experimental
description: Burst modulated alternating rectified current with a 10 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts
arm group label: Medium-frequency alternating current
arm group type: Experimental
description: Burst modulated alternating current with a 2500 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts
arm group label: Burst-modulated alternating current
arm group type: Experimental
description: Burst modulated alternating current with a 4000 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts.
arm group label: Placebo
arm group type: Placebo Comparator
description: Training with the intensity of 5 mA.
intervention type: Procedure
intervention name: Medium-frequency alternating current
description: 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.
arm group label: Medium-frequency alternating current
other name: MAC
intervention type: Procedure
intervention name: Burst-modulated alternating current
description: 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.
arm group label: Burst-modulated alternating current
other name: BMAC
intervention type: Procedure
intervention name: Placebo
description: 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.
arm group label: Placebo
intervention type: Procedure
intervention name: Functional electrical stimulation
description: 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
arm group label: Functional electrical stimulation
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gerson Cipriano Junior, PhD
role: Principal Investigator
affiliation: University of Brasilia
last name: Gerson Cipriano Junior, PhD
phone: +556181907111
email: cipriano@unb.br
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Brazil
citation: 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.
PMID: 22113369
citation: 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.
PMID: 14760336
citation: 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.
PMID: 14960741
responsible party type: Principal Investigator
investigator affiliation: University of Brasilia
investigator full name: Gerson Cipriano Jr
investigator title: Professor
mesh term: Heart Failure
mesh term: Chronic Disease