<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/NCT04499417</url>
  </required_header>
  <id_info>
    <org_study_id>EA4/058/19 (longterm trial)</org_study_id>
    <nct_id>NCT04499417</nct_id>
  </id_info>
  <brief_title>Psychological and Physical Effects of an 8-Week Electromyostimulation-Workout</brief_title>
  <official_title>Psychological and Physical Effects of an 8-Week Electromyostimulation-Whole-Body-Workout</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>miha bodytec GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</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>
      The study investigates the midterm, longterm and acute psychological and physical effects of&#xD;
      an 8-week whole-body-workout using Electromyostimulation (EMS) in healthy individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      EMS-whole-body-workouts are less time-consuming and effort-intensive but generate physical&#xD;
      effects which are comparable to conventional strength training. Therefore EMS could lower the&#xD;
      barrier to physical activity. The present study focusses on psychological and physical&#xD;
      effects of an 8-week EMS workout. Physical activity is notably important for mental and&#xD;
      physical health, but is on average far too rarely implemented. Therefore&#xD;
      EMS-whole-body-workouts could provide an opportunity to generate positive psychological and&#xD;
      physical effects through a less (subjective) cost-intense strength training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 19, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 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>The study has a randomised placebo-controlled parallel design (two arms: experimental-condition, sham-condition).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants and Outcomes Assessors are not aware of the study hypothesis / the condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Acute change of subjective well-being.</measure>
    <time_frame>From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.</time_frame>
    <description>• Subjective well-being is measured using a visual analogue scale (0-100%, higher value = better outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute change of subjective relaxation.</measure>
    <time_frame>From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.</time_frame>
    <description>• Subjective relaxation is measured using a visual analogue scale (0-100%, higher value = better outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of acute symptoms of anxiety and depression.</measure>
    <time_frame>From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.</time_frame>
    <description>• The State-Scale of the State-Trait-Anxiety-Depression-Inventar (STADI-State; Renner, Hock, Bergner-Köther &amp; Laux, 2018) is used to assess acute symptoms of depression and anxiety. The raw score ranges from 10 to 40, higher values indicate a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mid-/longterm changes in depressive symptoms.</measure>
    <time_frame>Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).</time_frame>
    <description>• Patient Health Questionnaire (PHQ-9; Kroenke &amp; Spitzer, 2002). Sum scores ranging from 0 to 27, higher values indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mid-/longterm changes in anxiety symptoms.</measure>
    <time_frame>Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).</time_frame>
    <description>• Generalized Anxiety Disorder Scale (GAD-7; Spitzer, Kroenke, Williams &amp; Löwe, 2006). Sum scores ranging from 0 to 21, higher values indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mid-/longterm changes in affect-related psychological variables.</measure>
    <time_frame>Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).</time_frame>
    <description>• The Trait-Scale of the State-Trait-Anxiety-Depression-Inventar (STADI-Trait; Renner, Hock, Bergner-Köther &amp; Laux, 2018) is used to assess symptoms of depression and anxiety. The raw score ranges from 10 to 40, higher values indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mid-/longterm changes in positive and negative affect.</measure>
    <time_frame>Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).</time_frame>
    <description>• Positive and Negative Affect Schedule (PANAS; Watson, Clark &amp; Tellegen, 1988). Positive subscale: Scores ranging from 10 to 50, higher scores represent a better outcome. Negative subscale: Scores ranging from 10 to 50, higher scores represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in general self-efficacy</measure>
    <time_frame>Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).</time_frame>
    <description>• General self-efficacy is measured using the General-Self-Efficacy Scale (GSE) by Jerusalem &amp; Schwarzer (1981). The GSE has 10 likert scaled items with values ranging from 1 to 4, higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in attitudes regarding physical activity (intentions for physical activity, self-efficacy regarding physical activity)</measure>
    <time_frame>Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).</time_frame>
    <description>• Intention (4 items) and self-efficacy (2 items) are measured using six likert scaled items by Petzold et al. (2017). Values ranging from 1 to 4, higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical parameters: heart rate variability.</measure>
    <time_frame>Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).</time_frame>
    <description>• Heart rate variability is measured with a polar chest strap during 5 minutes of relaxation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical parameters: hand force.</measure>
    <time_frame>Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).</time_frame>
    <description>• Hand force is measured with a hand-dynamometer left and right hand.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical parameters: leg strength.</measure>
    <time_frame>Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).</time_frame>
    <description>• Leg strength is assessed using the 30-second chair-stand-test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Experimental-Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 weeks x weekly 20 minutes whole-body-workouts with simultaneous muscle stimulation (EMS).&#xD;
Participants carry out easy whole-body-exercises while wearing a EMS-vest-belt-system with interwoven electrodes. During the workout the muscles are simultaneously stimulated by those external electrodes with medium level (5) of stimulation intensity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham-Condition</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>8 weeks x weekly 20 minutes whole-body-workouts without simultaneous muscle stimulation (EMS).&#xD;
Participants carry out easy whole-body-exercises while wearing a EMS-vest-belt-system with interwoven electrodes. During the workout the muscles are not actually stimulated by EMS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electromyostimulation Whole-Body-Workout</intervention_name>
    <description>Electromyostimulation - intensity 5 (muscle stimulation)</description>
    <arm_group_label>Experimental-Condition</arm_group_label>
    <other_name>EMS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electromyostimulation Sham Whole-Body-Workout</intervention_name>
    <description>Electromyostimulation - intensity 0 (no muscle stimulation)</description>
    <arm_group_label>Sham-Condition</arm_group_label>
    <other_name>EMS-Sham</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject familiarized with experimental procedure and had given written informed&#xD;
             consent&#xD;
&#xD;
          -  Able to understand German&#xD;
&#xD;
          -  Reachability of participant for the eight training sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for physical exercise or EMS-use&#xD;
&#xD;
          -  Current EMS-use or intense regular exercise (&gt; 60 min / week)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current presence of any mental disease&#xD;
&#xD;
          -  Acute suicidality&#xD;
&#xD;
          -  Substance dependencies with actual consumption (except nicotine)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Ströhle, Prof.Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antonia Bendau, M.Sc.Psych.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antonia Bendau, M.Sc.Psych.</last_name>
    <phone>+4930450517274</phone>
    <email>antonia.bendau@charite.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andreas Ströhle, Prof.Dr.</last_name>
    <phone>+4930450517217</phone>
    <email>andreas.stroehle@charite.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>ems@charite.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Antonia Bendau</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Physical Activity</keyword>
  <keyword>Exercise</keyword>
  <keyword>Mental Health</keyword>
  <keyword>Health Behaviour</keyword>
  <keyword>Electromyostimulation</keyword>
  <keyword>EMS</keyword>
  <keyword>Strength Training</keyword>
  <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/NCT04499417
org study id: EA4/058/19 (longterm trial)
nct id: NCT04499417
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study investigates the midterm, longterm and acute psychological and physical effects of
      an 8-week whole-body-workout using Electromyostimulation (EMS) in healthy individuals.
EMS-whole-body-workouts are less time-consuming and effort-intensive but generate physical
      effects which are comparable to conventional strength training. Therefore EMS could lower the
      barrier to physical activity. The present study focusses on psychological and physical
      effects of an 8-week EMS workout. Physical activity is notably important for mental and
      physical health, but is on average far too rarely implemented. Therefore
      EMS-whole-body-workouts could provide an opportunity to generate positive psychological and
      physical effects through a less (subjective) cost-intense strength training.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study has a randomised placebo-controlled parallel design (two arms: experimental-condition, sham-condition).
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Participants and Outcomes Assessors are not aware of the study hypothesis / the condition.
measure: Acute change of subjective well-being.
time frame: From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.
description: • Subjective well-being is measured using a visual analogue scale (0-100%, higher value = better outcome).
measure: Acute change of subjective relaxation.
time frame: From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.
description: • Subjective relaxation is measured using a visual analogue scale (0-100%, higher value = better outcome).
measure: Change of acute symptoms of anxiety and depression.
time frame: From directly before each of the eight training sessions do directly after each of the sessions (EMS-Training/Sham) during the 8 weeks of training.
description: • The State-Scale of the State-Trait-Anxiety-Depression-Inventar (STADI-State; Renner, Hock, Bergner-Köther & Laux, 2018) is used to assess acute symptoms of depression and anxiety. The raw score ranges from 10 to 40, higher values indicate a worse outcome.
measure: Mid-/longterm changes in depressive symptoms.
time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
description: • Patient Health Questionnaire (PHQ-9; Kroenke & Spitzer, 2002). Sum scores ranging from 0 to 27, higher values indicate a worse outcome.
measure: Mid-/longterm changes in anxiety symptoms.
time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
description: • Generalized Anxiety Disorder Scale (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006). Sum scores ranging from 0 to 21, higher values indicate a worse outcome.
measure: Mid-/longterm changes in affect-related psychological variables.
time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
description: • The Trait-Scale of the State-Trait-Anxiety-Depression-Inventar (STADI-Trait; Renner, Hock, Bergner-Köther & Laux, 2018) is used to assess symptoms of depression and anxiety. The raw score ranges from 10 to 40, higher values indicate a worse outcome.
measure: Mid-/longterm changes in positive and negative affect.
time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
description: • Positive and Negative Affect Schedule (PANAS; Watson, Clark & Tellegen, 1988). Positive subscale: Scores ranging from 10 to 50, higher scores represent a better outcome. Negative subscale: Scores ranging from 10 to 50, higher scores represent a worse outcome.
measure: Change in general self-efficacy
time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
description: • General self-efficacy is measured using the General-Self-Efficacy Scale (GSE) by Jerusalem & Schwarzer (1981). The GSE has 10 likert scaled items with values ranging from 1 to 4, higher scores mean a better outcome.
measure: Change in attitudes regarding physical activity (intentions for physical activity, self-efficacy regarding physical activity)
time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
description: • Intention (4 items) and self-efficacy (2 items) are measured using six likert scaled items by Petzold et al. (2017). Values ranging from 1 to 4, higher scores mean a better outcome.
measure: Change in physical parameters: heart rate variability.
time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
description: • Heart rate variability is measured with a polar chest strap during 5 minutes of relaxation.
measure: Change in physical parameters: hand force.
time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
description: • Hand force is measured with a hand-dynamometer left and right hand.
measure: Change in physical parameters: leg strength.
time frame: Baseline (before any training) + Intermediate (4 weeks) + Post (8 weeks) + Follow-Up (12 weeks).
description: • Leg strength is assessed using the 30-second chair-stand-test.
arm group label: Experimental-Condition
arm group type: Experimental
description: 8 weeks x weekly 20 minutes whole-body-workouts with simultaneous muscle stimulation (EMS).
Participants carry out easy whole-body-exercises while wearing a EMS-vest-belt-system with interwoven electrodes. During the workout the muscles are simultaneously stimulated by those external electrodes with medium level (5) of stimulation intensity.
arm group label: Sham-Condition
arm group type: Sham Comparator
description: 8 weeks x weekly 20 minutes whole-body-workouts without simultaneous muscle stimulation (EMS).
Participants carry out easy whole-body-exercises while wearing a EMS-vest-belt-system with interwoven electrodes. During the workout the muscles are not actually stimulated by EMS.
intervention type: Device
intervention name: Electromyostimulation Whole-Body-Workout
description: Electromyostimulation - intensity 5 (muscle stimulation)
arm group label: Experimental-Condition
other name: EMS
intervention type: Device
intervention name: Electromyostimulation Sham Whole-Body-Workout
description: Electromyostimulation - intensity 0 (no muscle stimulation)
arm group label: Sham-Condition
other name: EMS-Sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andreas Ströhle, Prof.Dr.
role: Study Director
affiliation: Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
last name: Antonia Bendau, M.Sc.Psych.
role: Principal Investigator
affiliation: Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
last name: Antonia Bendau, M.Sc.Psych.
phone: +4930450517274
email: antonia.bendau@charite.de
last name: Andreas Ströhle, Prof.Dr.
phone: +4930450517217
email: andreas.stroehle@charite.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Antonia Bendau
investigator title: Principal Investigator
sharing ipd: No