<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/NCT03767088</url>
  </required_header>
  <id_info>
    <org_study_id>UWittenHerdecke</org_study_id>
    <nct_id>NCT03767088</nct_id>
  </id_info>
  <brief_title>Whole-body Electromyostimulation in Inpatient Rehabilitation</brief_title>
  <acronym>GERKO</acronym>
  <official_title>Evaluation of Whole-body Electromyostimulation (WB-EMS) in the Context of Inpatient Rehabilitation of Cardiological and Orthopedic Patients by Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Frank Mooren</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Witten/Herdecke</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Based on various studies, scientific evidence has proven the effectiveness of whole-body&#xD;
      electromyostimulation (WB-EMS) on parameters such as increased physiological performance and&#xD;
      body composition.&#xD;
&#xD;
      As a pilot project, the aim of the study is to determine the effect of additional WB-EMS as&#xD;
      part of the inpatient four-week rehabilitation of sarcopenic subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The loss of muscle mass in the age-associated process (sarcopenia) is a common indication in&#xD;
      the field of orthopedic and cardiac rehabilitation, which may also be reinforced by previous&#xD;
      immobilization and disuse of the muscles (atrophy of muscle). Sarcopenia is defined as 2&#xD;
      standard deviations of average of the same sex in middle adult life. The present project&#xD;
      focuses on the sarcopenia definition of the Foundation for the National Institutes of Health&#xD;
      (FNIH). Their limits are &lt; 0.789 (men) and &lt; 0.512 (women) and are calculated by adding the&#xD;
      absolute muscle mass of the extremities divided by the body mass index (BMI).&#xD;
&#xD;
      Due to reduced muscle mass and thus limited strength / performance, the implementation of&#xD;
      conventional training tools with regard to generate corresponding intensities is no longer&#xD;
      possible, or in persons with additional cardiac or orthopedic restrictions heavily limited.&#xD;
&#xD;
      In view of the existing indications, the alternative training technology whole-body&#xD;
      electromyostimulation (WB-EMS) is an adequate training tool for the rehabilitation process.&#xD;
      The time-saving (max 20 minutes per training session) and effective training method is&#xD;
      characterized by low orthopedic and cardiac stress. Thus, WB-EMS combines both relevant&#xD;
      aspects of a joint-friendly training with effects on muscle mass and functionality. Through&#xD;
      the simultaneous activation of up to 10 muscle regions with corresponding, subjectively&#xD;
      decidedly adjustable intensity per muscle group, up to 2,800 cm2 can be addressed.&#xD;
      Synchronized to a motion video, the participants perform light physical exercises in parallel&#xD;
      to the current pulses.&#xD;
&#xD;
      The aim of the study is, to evaluate the effect of additional WB-EMS during a 4-week period&#xD;
      of inpatient rehabilitation, comparing 3 groups:&#xD;
&#xD;
        1. WB-EMS, stimulating 8 muscle groups (legs,arms, core, gluteal region)&#xD;
&#xD;
        2. partial-WB-EMS, just stimulating the lower extremities (legs, gluteal region)&#xD;
&#xD;
        3. control, just performing the functional, mainly eccentric motion pattern without&#xD;
           stimulation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">March 15, 2020</completion_date>
  <primary_completion_date type="Actual">March 15, 2020</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 parallel group design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>(isometric) muscle strength of arms, legs and trunk (extenstion)</measure>
    <time_frame>4 weeks</time_frame>
    <description>isometric strength [Nm] (DIERs Myoline professional, DIERs International GmbH)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>muscle function</measure>
    <time_frame>4 weeks</time_frame>
    <description>chair rise test [repetitions; n]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>muscle function / submaximal performance test</measure>
    <time_frame>4 weeks</time_frame>
    <description>6 minute walking test [distance; m]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>muscle mass via multifrequency bioimpedance analysis</measure>
    <time_frame>4 weeks</time_frame>
    <description>via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body fat via multifrequency bioimpedance analysis</measure>
    <time_frame>4 weeks</time_frame>
    <description>via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood-sample: triglycerides</measure>
    <time_frame>4 weeks</time_frame>
    <description>blood-sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood-sample: high-density lipoprotein (HDL)</measure>
    <time_frame>4 weeks</time_frame>
    <description>blood-sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood-sample: low-density lipoprotein (LDL)</measure>
    <time_frame>4 weeks</time_frame>
    <description>blood-sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood-sample: Crea/glomerular filtration rate (GfR)</measure>
    <time_frame>4 weeks</time_frame>
    <description>blood-sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood-sample: glutamate oxaloacetate transaminase (GOT)</measure>
    <time_frame>4 weeks</time_frame>
    <description>blood-sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood-sample: glutamic pyruvic transaminase (GPT)</measure>
    <time_frame>4 weeks</time_frame>
    <description>blood-sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood-sample: gamma-glutamyl transpeptidase (GGT)</measure>
    <time_frame>4 weeks</time_frame>
    <description>blood-sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood-sample: creatine kinase (CK)</measure>
    <time_frame>4 weeks</time_frame>
    <description>blood-sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood-sample: myoglobin</measure>
    <time_frame>4 weeks</time_frame>
    <description>blood-sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood-sample: sodium</measure>
    <time_frame>4 weeks</time_frame>
    <description>blood-sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>potassium</measure>
    <time_frame>4 weeks</time_frame>
    <description>blood-sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>life quality</measure>
    <time_frame>4 weeks</time_frame>
    <description>questionnaire: Short Form 36 Health Survey (SF-36)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self-efficacy</measure>
    <time_frame>4 weeks</time_frame>
    <description>questionnaire: Allgemeine Selbstwirksamkeit Kurzskala (ASKU)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>activities of daily living</measure>
    <time_frame>4 weeks</time_frame>
    <description>questionnaire: Late-Life Function &amp; Disability Instrument (LLFDI)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>WB-EMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session stimulation of 8 muscle groups (legs, gluteal region, core, arms) while performing slight eccentric pronounced physiological movement patterns parameters: 85 Hz, 350ms, intermittent, 4 s load vs 4 s regeneration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>partial WB-EMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session stimulation of 2 muscle groups (legs, gluteal region; lower extremities) while performing slight eccentric pronounced physiological movement patterns parameters: 85 Hz, 350ms, intermittent, 4 s load vs 4 s regeneration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>active sham comparator: 1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session performing slight eccentric pronounced physiological movement patterns</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WB-EMS</intervention_name>
    <description>whole body electromyostimulation</description>
    <arm_group_label>WB-EMS</arm_group_label>
    <arm_group_label>partial WB-EMS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>(synchronized) Training program without WB-EMS</intervention_name>
    <description>20 min of pronounced eccentric movement patterns</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. skeletal muscle index (SMI) &lt; 0,789 (men); &lt; 0,512 (women)&#xD;
&#xD;
          2. A general state of good health&#xD;
&#xD;
          3. Medically approved unrestricted sports participation as shown by diagnostic&#xD;
             performance test&#xD;
&#xD;
          4. Willingness to provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Post-coronary artery bypass graft (ACVB) surgery in the last 3 months&#xD;
&#xD;
          2. Condition after pacemaker and defibrillator implantation&#xD;
&#xD;
          3. renal insufficiency from stage 3a&#xD;
&#xD;
          4. epilepsy&#xD;
&#xD;
          5. feverish diseases or infectious diseases&#xD;
&#xD;
          6. Taking medicines the affect muscle metabolism&#xD;
&#xD;
          7. severe neurological disorders&#xD;
&#xD;
          8. Skin injuries in the area of electrodes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank C Mooren, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Rehabilitation Science</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik Königsfeld der DRV</name>
      <address>
        <city>Ennepetal</city>
        <state>NRW</state>
        <zip>58256</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>May 12, 2021</last_update_submitted>
  <last_update_submitted_qc>May 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Witten/Herdecke</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Frank Mooren</investigator_full_name>
    <investigator_title>Prof. Dr. med. (Lehrstuhl für Rehabilitationswissenschaften)</investigator_title>
  </responsible_party>
  <keyword>WB-EMS</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>sarcopenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</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/NCT03767088
org study id: UWittenHerdecke
nct id: NCT03767088
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Based on various studies, scientific evidence has proven the effectiveness of whole-body
      electromyostimulation (WB-EMS) on parameters such as increased physiological performance and
      body composition.

      As a pilot project, the aim of the study is to determine the effect of additional WB-EMS as
      part of the inpatient four-week rehabilitation of sarcopenic subjects.
The loss of muscle mass in the age-associated process (sarcopenia) is a common indication in
      the field of orthopedic and cardiac rehabilitation, which may also be reinforced by previous
      immobilization and disuse of the muscles (atrophy of muscle). Sarcopenia is defined as 2
      standard deviations of average of the same sex in middle adult life. The present project
      focuses on the sarcopenia definition of the Foundation for the National Institutes of Health
      (FNIH). Their limits are < 0.789 (men) and < 0.512 (women) and are calculated by adding the
      absolute muscle mass of the extremities divided by the body mass index (BMI).

      Due to reduced muscle mass and thus limited strength / performance, the implementation of
      conventional training tools with regard to generate corresponding intensities is no longer
      possible, or in persons with additional cardiac or orthopedic restrictions heavily limited.

      In view of the existing indications, the alternative training technology whole-body
      electromyostimulation (WB-EMS) is an adequate training tool for the rehabilitation process.
      The time-saving (max 20 minutes per training session) and effective training method is
      characterized by low orthopedic and cardiac stress. Thus, WB-EMS combines both relevant
      aspects of a joint-friendly training with effects on muscle mass and functionality. Through
      the simultaneous activation of up to 10 muscle regions with corresponding, subjectively
      decidedly adjustable intensity per muscle group, up to 2,800 cm2 can be addressed.
      Synchronized to a motion video, the participants perform light physical exercises in parallel
      to the current pulses.

      The aim of the study is, to evaluate the effect of additional WB-EMS during a 4-week period
      of inpatient rehabilitation, comparing 3 groups:

        1. WB-EMS, stimulating 8 muscle groups (legs,arms, core, gluteal region)

        2. partial-WB-EMS, just stimulating the lower extremities (legs, gluteal region)

        3. control, just performing the functional, mainly eccentric motion pattern without
           stimulation
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective randomized controlled parallel group design
primary purpose: Treatment
masking: None (Open Label)
measure: (isometric) muscle strength of arms, legs and trunk (extenstion)
time frame: 4 weeks
description: isometric strength [Nm] (DIERs Myoline professional, DIERs International GmbH)
measure: muscle function
time frame: 4 weeks
description: chair rise test [repetitions; n]
measure: muscle function / submaximal performance test
time frame: 4 weeks
description: 6 minute walking test [distance; m]
measure: muscle mass via multifrequency bioimpedance analysis
time frame: 4 weeks
description: via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)
measure: body fat via multifrequency bioimpedance analysis
time frame: 4 weeks
description: via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)
measure: blood-sample: triglycerides
time frame: 4 weeks
description: blood-sample
measure: blood-sample: high-density lipoprotein (HDL)
time frame: 4 weeks
description: blood-sample
measure: blood-sample: low-density lipoprotein (LDL)
time frame: 4 weeks
description: blood-sample
measure: blood-sample: Crea/glomerular filtration rate (GfR)
time frame: 4 weeks
description: blood-sample
measure: blood-sample: glutamate oxaloacetate transaminase (GOT)
time frame: 4 weeks
description: blood-sample
measure: blood-sample: glutamic pyruvic transaminase (GPT)
time frame: 4 weeks
description: blood-sample
measure: blood-sample: gamma-glutamyl transpeptidase (GGT)
time frame: 4 weeks
description: blood-sample
measure: blood-sample: creatine kinase (CK)
time frame: 4 weeks
description: blood-sample
measure: blood-sample: myoglobin
time frame: 4 weeks
description: blood-sample
measure: blood-sample: sodium
time frame: 4 weeks
description: blood-sample
measure: potassium
time frame: 4 weeks
description: blood-sample
measure: life quality
time frame: 4 weeks
description: questionnaire: Short Form 36 Health Survey (SF-36)
measure: self-efficacy
time frame: 4 weeks
description: questionnaire: Allgemeine Selbstwirksamkeit Kurzskala (ASKU)
measure: activities of daily living
time frame: 4 weeks
description: questionnaire: Late-Life Function & Disability Instrument (LLFDI)
arm group label: WB-EMS
arm group type: Active Comparator
description: 1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session stimulation of 8 muscle groups (legs, gluteal region, core, arms) while performing slight eccentric pronounced physiological movement patterns parameters: 85 Hz, 350ms, intermittent, 4 s load vs 4 s regeneration
arm group label: partial WB-EMS
arm group type: Active Comparator
description: 1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session stimulation of 2 muscle groups (legs, gluteal region; lower extremities) while performing slight eccentric pronounced physiological movement patterns parameters: 85 Hz, 350ms, intermittent, 4 s load vs 4 s regeneration
arm group label: control
arm group type: Sham Comparator
description: active sham comparator: 1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session performing slight eccentric pronounced physiological movement patterns
intervention type: Device
intervention name: WB-EMS
description: whole body electromyostimulation
arm group label: WB-EMS
arm group label: partial WB-EMS
intervention type: Other
intervention name: (synchronized) Training program without WB-EMS
description: 20 min of pronounced eccentric movement patterns
arm group label: control
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Frank C Mooren, Prof
role: Principal Investigator
affiliation: Department of Rehabilitation Science
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: University of Witten/Herdecke
investigator full name: Prof. Dr. Frank Mooren
investigator title: Prof. Dr. med. (Lehrstuhl für Rehabilitationswissenschaften)
mesh term: Sarcopenia