<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/NCT03793647</url>
  </required_header>
  <id_info>
    <org_study_id>2018-00273</org_study_id>
    <nct_id>NCT03793647</nct_id>
  </id_info>
  <brief_title>Electrical Muscle Stimulation in Congestive Heart Failure</brief_title>
  <official_title>Electrical Muscle Stimulation in Severely Deconditioned Congestive Heart Failure Patients- a Prospective, Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kantonsspital Olten</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kantonsspital Olten</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is to evaluate two types of electrical muscle Stimulation (EMS) stimulation (low&#xD;
      intensity &quot;conventional stimulation&quot; vs. high intensity &quot;Russian&quot; stimulation) of legs in&#xD;
      comparison with a control group without EMS in a cohort of elderly patients with severe&#xD;
      deconditioning after CHF decompensation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND:&#xD;
&#xD;
      Congestive heart failure (CHF) is increasingly prevalent worldwide and is associated with&#xD;
      significant morbidity and mortality. Poor exercise capacity is well known as a risk factor&#xD;
      for poor prognosis. The deconditioning is mainly associated with a decrease in leg muscle&#xD;
      mass and loss of leg strength as well as loss of muscle endurance. This affects especially&#xD;
      elderly patients. To improve this condition in CHF electrical muscle stimulation (EMS) is a&#xD;
      suitable method of training, which hardly affects the heart. However, most EMS existing&#xD;
      stimulation protocols are uncomfortable and not user-friendly, especially for elderly&#xD;
      patients. The Russian space medicine has many years' experience in specific EMS stimulation&#xD;
      protocols, which are well tolerated by cosmonauts for hours even during working activities.&#xD;
      Therefore, a research project has been established between the Russian Academy of Sciences&#xD;
      (Laboratory for Biomedical Problems) and the ARTORG Research Center for Biomedical&#xD;
      Engineering to study the effects of new developed EMS procedures in elderly persons.&#xD;
&#xD;
      Aims:&#xD;
&#xD;
      The aim of trial is to evaluate two types of EMS stimulation (low intensity &quot;conventional&#xD;
      stimulation&quot; vs. high intensity &quot;Russian&quot; stimulation) of legs in comparison with a control&#xD;
      group without EMS in a cohort of elderly patients with severe deconditioning after CHF&#xD;
      decompensation.&#xD;
&#xD;
      METHOTOLOGY:&#xD;
&#xD;
      This prospective, randomized controlled study will use commercially available electronic&#xD;
      stimulator devices (Medel GmbH, Hamburg, Germany) for EMS. For the &quot;Russian&quot; stimulation, an&#xD;
      especial developed stimulator (Amplidin-EST No.5) will be used for frequency modulation of&#xD;
      the stimulation impulse, which is supposed to make stimulation sensation more comfortable.&#xD;
      Supervised EMS training will be performed 5 times per week (weekdays) during 30 minutes over&#xD;
      a period of 6 weeks in elderly deconditioned CHF patients, starting at the Kantonsspital&#xD;
      Olten during the hospitalisation and continued at home. We will include 20 patients in each&#xD;
      group (20 in control group, 20 in low intensity &quot;conventional group and 20 in high intensity&#xD;
      &quot;Russian&quot; group). The control group was preformed to exclude an attention bias in the study&#xD;
      results. The primary endpoint of the study is the difference in maximum oxygen uptake (peak&#xD;
      VO2) and in 6 minutes walking distance between baseline and after 6-weeks EMS training in all&#xD;
      groups (high intensity vs low intensity vs control). The follow-up period is planned for 2&#xD;
      years.&#xD;
&#xD;
      POTENTIAL SIGNIFICANCE:&#xD;
&#xD;
      Exercise capacity and quality of life in severely deconditioned patients with CHF is poor and&#xD;
      life expectancy is low. While the possibilities to improve the poor condition and function of&#xD;
      the heart by pharmaceutical therapies are limited, there is potential to improve the&#xD;
      condition of the peripheral muscles by exercise training. However, a successful aerobic&#xD;
      training is rarely feasible in these patients. Therefore, EMS training may prove to be ideal&#xD;
      tool to improve leg muscle mass and function of elderly patients. Because, CHF patients do&#xD;
      not tolerate most of the existing EMS stimulation protocols, we have developed a new EMS&#xD;
      stimulation protocol. The application is virtually painless and therefore well tolerated over&#xD;
      hours due to a sophisticated stimulation protocol. Therefore, we hope that, this especial for&#xD;
      elderly CHF patients developed training protocol, may improve their daily activity as well as&#xD;
      their quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2021</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>
    <intervention_model_description>Prospective, randomized controlled study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in 6 minutes walking distance after EMS training</measure>
    <time_frame>2 years</time_frame>
    <description>The primary outcome of the study is the difference in 6 minutes walking distance (m) between baseline and after 6-weeks EMS training in all groups (high intensity vs low intensity vs control).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Congestive Heart Failure</condition>
  <condition>Electric Muscle Stimulation</condition>
  <condition>Severe Decondition</condition>
  <condition>Elderly Person</condition>
  <condition>Exercise Capacity</condition>
  <condition>Activities of Daily Living</condition>
  <arm_group>
    <arm_group_label>Low Intensity EMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional Stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Intensity EMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Russian Stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>no Stimulation, supported by phone contact</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrical muscle devise</intervention_name>
    <description>evaluate two types of EMS stimulation of legs</description>
    <arm_group_label>High Intensity EMS</arm_group_label>
    <arm_group_label>Low Intensity EMS</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 60 years&#xD;
&#xD;
          -  hospitalized due to heart failure&#xD;
&#xD;
          -  left ventricular ejection fraction ≤ 40%&#xD;
&#xD;
          -  NYHA class II to IV&#xD;
&#xD;
          -  willingness to complete the 6-week EMS training programme&#xD;
&#xD;
          -  tolerability of the electrical stimulation&#xD;
&#xD;
          -  provision of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe neuromuscular or oncologic diseases with inability to perform exercise testing&#xD;
             and EMS training&#xD;
&#xD;
          -  inotropic intravenous agents used (≤10 days)&#xD;
&#xD;
          -  implanted pacemaker/ICD&#xD;
&#xD;
          -  unstable angina&#xD;
&#xD;
          -  severe uncontrolled arrhythmias&#xD;
&#xD;
          -  patients with severe pulmonary limitation (Tiffeneau ratio &lt;70%, or vital capacity&#xD;
             &lt;70% of predicted value)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nisha Arenja</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kantonsspital Olten</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nisha Arenja, Dr</last_name>
    <phone>0041 62 311 49 45</phone>
    <email>nisha.arenja@spital.so.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hugo Saner, Prof.</last_name>
    <email>Hugo.Saner@insel.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kantonsspital Olten</name>
      <address>
        <city>Olten</city>
        <zip>4600</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nisha Arenja, Dr</last_name>
      <phone>0041 62 311 49 45</phone>
      <email>nisha.arenja@spital.so.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Deley G, Kervio G, Verges B, Hannequin A, Petitdant MF, Salmi-Belmihoub S, Grassi B, Casillas JM. Comparison of low-frequency electrical myostimulation and conventional aerobic exercise training in patients with chronic heart failure. Eur J Cardiovasc Prev Rehabil. 2005 Jun;12(3):226-33. doi: 10.1097/01.hjr.0000166455.23346.a5.</citation>
    <PMID>15942420</PMID>
  </reference>
  <reference>
    <citation>Dobsak P, Novakova M, Siegelova J, Fiser B, Vitovec J, Nagasaka M, Kohzuki M, Yambe T, Nitta S, Eicher JC, Wolf JE, Imachi K. Low-frequency electrical stimulation increases muscle strength and improves blood supply in patients with chronic heart failure. Circ J. 2006 Jan;70(1):75-82. doi: 10.1253/circj.70.75.</citation>
    <PMID>16377928</PMID>
  </reference>
  <reference>
    <citation>Harris S, LeMaitre JP, Mackenzie G, Fox KA, Denvir MA. A randomised study of home-based electrical stimulation of the legs and conventional bicycle exercise training for patients with chronic heart failure. Eur Heart J. 2003 May;24(9):871-8. doi: 10.1016/s0195-668x(02)00822-9.</citation>
    <PMID>12727155</PMID>
  </reference>
  <reference>
    <citation>Karavidas A, Arapi SM, Pyrgakis V, Adamopoulos S. Functional electrical stimulation of lower limbs in patients with chronic heart failure. Heart Fail Rev. 2010 Nov;15(6):563-79. doi: 10.1007/s10741-010-9171-9.</citation>
    <PMID>20490656</PMID>
  </reference>
  <reference>
    <citation>Karavidas A, Driva M, Parissis JT, Farmakis D, Mantzaraki V, Varounis C, Paraskevaidis I, Ikonomidis I, Pirgakis V, Anastasiou-Nana M, Filippatos G. Functional electrical stimulation of peripheral muscles improves endothelial function and clinical and emotional status in heart failure patients with preserved left ventricular ejection fraction. Am Heart J. 2013 Oct;166(4):760-7. doi: 10.1016/j.ahj.2013.06.021. Epub 2013 Aug 30.</citation>
    <PMID>24093858</PMID>
  </reference>
  <reference>
    <citation>Nuhr M, Crevenna R, Gohlsch B, Bittner C, Pleiner J, Wiesinger G, Fialka-Moser V, Quittan M, Pette D. Functional and biochemical properties of chronically stimulated human skeletal muscle. Eur J Appl Physiol. 2003 Apr;89(2):202-8. doi: 10.1007/s00421-003-0792-8. Epub 2003 Feb 28.</citation>
    <PMID>12665986</PMID>
  </reference>
  <reference>
    <citation>Quittan M, Sochor A, Wiesinger GF, Kollmitzer J, Sturm B, Pacher R, Mayr W. Strength improvement of knee extensor muscles in patients with chronic heart failure by neuromuscular electrical stimulation. Artif Organs. 1999 May;23(5):432-5. doi: 10.1046/j.1525-1594.1999.06372.x.</citation>
    <PMID>10378936</PMID>
  </reference>
  <reference>
    <citation>Sbruzzi G, Ribeiro RA, Schaan BD, Signori LU, Silva AM, Irigoyen MC, Plentz RD. Functional electrical stimulation in the treatment of patients with chronic heart failure: a meta-analysis of randomized controlled trials. Eur J Cardiovasc Prev Rehabil. 2010 Jun;17(3):254-60. doi: 10.1097/HJR.0b013e328339b5a2.</citation>
    <PMID>20560163</PMID>
  </reference>
  <reference>
    <citation>Smart NA, Dieberg G, Giallauria F. Functional electrical stimulation for chronic heart failure: a meta-analysis. Int J Cardiol. 2013 Jul 15;167(1):80-6. doi: 10.1016/j.ijcard.2011.12.019. Epub 2012 Jan 10.</citation>
    <PMID>22236510</PMID>
  </reference>
  <reference>
    <citation>Vaquero AF, Chicharro JL, Gil L, Ruiz MP, Sanchez V, Lucia A, Urrea S, Gomez MA. Effects of muscle electrical stimulation on peak VO2 in cardiac transplant patients. Int J Sports Med. 1998 Jul;19(5):317-22. doi: 10.1055/s-2007-971924.</citation>
    <PMID>9721054</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>October 5, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>April 11, 2021</last_update_submitted>
  <last_update_submitted_qc>April 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kantonsspital Olten</investigator_affiliation>
    <investigator_full_name>Nisha Arenja</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03793647
org study id: 2018-00273
nct id: NCT03793647
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial is to evaluate two types of electrical muscle Stimulation (EMS) stimulation (low
      intensity "conventional stimulation" vs. high intensity "Russian" stimulation) of legs in
      comparison with a control group without EMS in a cohort of elderly patients with severe
      deconditioning after CHF decompensation.
BACKGROUND:

      Congestive heart failure (CHF) is increasingly prevalent worldwide and is associated with
      significant morbidity and mortality. Poor exercise capacity is well known as a risk factor
      for poor prognosis. The deconditioning is mainly associated with a decrease in leg muscle
      mass and loss of leg strength as well as loss of muscle endurance. This affects especially
      elderly patients. To improve this condition in CHF electrical muscle stimulation (EMS) is a
      suitable method of training, which hardly affects the heart. However, most EMS existing
      stimulation protocols are uncomfortable and not user-friendly, especially for elderly
      patients. The Russian space medicine has many years' experience in specific EMS stimulation
      protocols, which are well tolerated by cosmonauts for hours even during working activities.
      Therefore, a research project has been established between the Russian Academy of Sciences
      (Laboratory for Biomedical Problems) and the ARTORG Research Center for Biomedical
      Engineering to study the effects of new developed EMS procedures in elderly persons.

      Aims:

      The aim of trial is to evaluate two types of EMS stimulation (low intensity "conventional
      stimulation" vs. high intensity "Russian" stimulation) of legs in comparison with a control
      group without EMS in a cohort of elderly patients with severe deconditioning after CHF
      decompensation.

      METHOTOLOGY:

      This prospective, randomized controlled study will use commercially available electronic
      stimulator devices (Medel GmbH, Hamburg, Germany) for EMS. For the "Russian" stimulation, an
      especial developed stimulator (Amplidin-EST No.5) will be used for frequency modulation of
      the stimulation impulse, which is supposed to make stimulation sensation more comfortable.
      Supervised EMS training will be performed 5 times per week (weekdays) during 30 minutes over
      a period of 6 weeks in elderly deconditioned CHF patients, starting at the Kantonsspital
      Olten during the hospitalisation and continued at home. We will include 20 patients in each
      group (20 in control group, 20 in low intensity "conventional group and 20 in high intensity
      "Russian" group). The control group was preformed to exclude an attention bias in the study
      results. The primary endpoint of the study is the difference in maximum oxygen uptake (peak
      VO2) and in 6 minutes walking distance between baseline and after 6-weeks EMS training in all
      groups (high intensity vs low intensity vs control). The follow-up period is planned for 2
      years.

      POTENTIAL SIGNIFICANCE:

      Exercise capacity and quality of life in severely deconditioned patients with CHF is poor and
      life expectancy is low. While the possibilities to improve the poor condition and function of
      the heart by pharmaceutical therapies are limited, there is potential to improve the
      condition of the peripheral muscles by exercise training. However, a successful aerobic
      training is rarely feasible in these patients. Therefore, EMS training may prove to be ideal
      tool to improve leg muscle mass and function of elderly patients. Because, CHF patients do
      not tolerate most of the existing EMS stimulation protocols, we have developed a new EMS
      stimulation protocol. The application is virtually painless and therefore well tolerated over
      hours due to a sophisticated stimulation protocol. Therefore, we hope that, this especial for
      elderly CHF patients developed training protocol, may improve their daily activity as well as
      their quality of life.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized controlled study
primary purpose: Prevention
masking: Single (Investigator)
measure: Difference in 6 minutes walking distance after EMS training
time frame: 2 years
description: The primary outcome of the study is the difference in 6 minutes walking distance (m) between baseline and after 6-weeks EMS training in all groups (high intensity vs low intensity vs control).
arm group label: Low Intensity EMS
arm group type: Active Comparator
description: Conventional Stimulation
arm group label: High Intensity EMS
arm group type: Experimental
description: Russian Stimulation
arm group label: Placebo
arm group type: Placebo Comparator
description: no Stimulation, supported by phone contact
intervention type: Device
intervention name: Electrical muscle devise
description: evaluate two types of EMS stimulation of legs
arm group label: High Intensity EMS
arm group label: Low Intensity EMS
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Nisha Arenja
role: Principal Investigator
affiliation: Kantonsspital Olten
last name: Nisha Arenja, Dr
phone: 0041 62 311 49 45
email: nisha.arenja@spital.so.ch
last name: Hugo Saner, Prof.
email: Hugo.Saner@insel.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
citation: Deley G, Kervio G, Verges B, Hannequin A, Petitdant MF, Salmi-Belmihoub S, Grassi B, Casillas JM. Comparison of low-frequency electrical myostimulation and conventional aerobic exercise training in patients with chronic heart failure. Eur J Cardiovasc Prev Rehabil. 2005 Jun;12(3):226-33. doi: 10.1097/01.hjr.0000166455.23346.a5.
PMID: 15942420
citation: Dobsak P, Novakova M, Siegelova J, Fiser B, Vitovec J, Nagasaka M, Kohzuki M, Yambe T, Nitta S, Eicher JC, Wolf JE, Imachi K. Low-frequency electrical stimulation increases muscle strength and improves blood supply in patients with chronic heart failure. Circ J. 2006 Jan;70(1):75-82. doi: 10.1253/circj.70.75.
PMID: 16377928
citation: Harris S, LeMaitre JP, Mackenzie G, Fox KA, Denvir MA. A randomised study of home-based electrical stimulation of the legs and conventional bicycle exercise training for patients with chronic heart failure. Eur Heart J. 2003 May;24(9):871-8. doi: 10.1016/s0195-668x(02)00822-9.
PMID: 12727155
citation: Karavidas A, Arapi SM, Pyrgakis V, Adamopoulos S. Functional electrical stimulation of lower limbs in patients with chronic heart failure. Heart Fail Rev. 2010 Nov;15(6):563-79. doi: 10.1007/s10741-010-9171-9.
PMID: 20490656
citation: Karavidas A, Driva M, Parissis JT, Farmakis D, Mantzaraki V, Varounis C, Paraskevaidis I, Ikonomidis I, Pirgakis V, Anastasiou-Nana M, Filippatos G. Functional electrical stimulation of peripheral muscles improves endothelial function and clinical and emotional status in heart failure patients with preserved left ventricular ejection fraction. Am Heart J. 2013 Oct;166(4):760-7. doi: 10.1016/j.ahj.2013.06.021. Epub 2013 Aug 30.
PMID: 24093858
citation: Nuhr M, Crevenna R, Gohlsch B, Bittner C, Pleiner J, Wiesinger G, Fialka-Moser V, Quittan M, Pette D. Functional and biochemical properties of chronically stimulated human skeletal muscle. Eur J Appl Physiol. 2003 Apr;89(2):202-8. doi: 10.1007/s00421-003-0792-8. Epub 2003 Feb 28.
PMID: 12665986
citation: Quittan M, Sochor A, Wiesinger GF, Kollmitzer J, Sturm B, Pacher R, Mayr W. Strength improvement of knee extensor muscles in patients with chronic heart failure by neuromuscular electrical stimulation. Artif Organs. 1999 May;23(5):432-5. doi: 10.1046/j.1525-1594.1999.06372.x.
PMID: 10378936
citation: Sbruzzi G, Ribeiro RA, Schaan BD, Signori LU, Silva AM, Irigoyen MC, Plentz RD. Functional electrical stimulation in the treatment of patients with chronic heart failure: a meta-analysis of randomized controlled trials. Eur J Cardiovasc Prev Rehabil. 2010 Jun;17(3):254-60. doi: 10.1097/HJR.0b013e328339b5a2.
PMID: 20560163
citation: Smart NA, Dieberg G, Giallauria F. Functional electrical stimulation for chronic heart failure: a meta-analysis. Int J Cardiol. 2013 Jul 15;167(1):80-6. doi: 10.1016/j.ijcard.2011.12.019. Epub 2012 Jan 10.
PMID: 22236510
citation: Vaquero AF, Chicharro JL, Gil L, Ruiz MP, Sanchez V, Lucia A, Urrea S, Gomez MA. Effects of muscle electrical stimulation on peak VO2 in cardiac transplant patients. Int J Sports Med. 1998 Jul;19(5):317-22. doi: 10.1055/s-2007-971924.
PMID: 9721054
responsible party type: Principal Investigator
investigator affiliation: Kantonsspital Olten
investigator full name: Nisha Arenja
investigator title: Principle Investigator
mesh term: Heart Failure
sharing ipd: No