<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/NCT03306056</url>
  </required_header>
  <id_info>
    <org_study_id>EKAM-Study</org_study_id>
    <nct_id>NCT03306056</nct_id>
  </id_info>
  <brief_title>Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals</brief_title>
  <acronym>EKAM</acronym>
  <official_title>Comparison of the Effects of Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals at Increased Cardiometabolic Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</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>
      The main purpose of this study is to compare the effects of whole-body electromyostimulation&#xD;
      versus a conventional low-volume strength-training program, each combined with an&#xD;
      individualized, weight-reducing diet, on the cardiometabolic risk profile, muscle strength,&#xD;
      body composition, inflammatory markers and subjective health outcomes in overweight&#xD;
      individuals at increased cardiometabolic risk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 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>parallel-group, randomized-controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Metabolic Syndrome Z-Score (MetS-Z-Score)</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>MetS-Z-Score will be calculated from each individual's measures of waist circumference, mean arterial blood pressure, triglycerides, and HDL-cholesterol, based on equations specific to sex.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Muscle strength of the five major muscle groups (chest, upper back, lower back, abdominals, legs) will be assessed by using specific strength-training devices (Butterfly, Pull-down, Hyperextension, Abdominal Crunch, Leg-Press)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiorespiratory Fitness (CRF)</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation status</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Inflammation will be assessed by measuring Levels of CRP and inflammatory cytokines and other inflammatory blood markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived stress</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective work ability</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Overweight and Obesity</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutritional therapy / no exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Strength Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutritional therapy combined with a Standard Strength Training program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-volume Strength Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutritional therapy combined with a low-volume Strength Training program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whole-body Electromyostimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutritional therapy combined with Whole-Body Electromyostimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Strength Training</intervention_name>
    <description>Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with a standard strength training program:&#xD;
5 strength training exercises (chest, upper/lower back, abdominals, legs)&#xD;
3 sets per exercise&#xD;
time-effort per session: ~90 min&#xD;
2 training sessions per week&#xD;
duration of exercise intervention: 12 weeks</description>
    <arm_group_label>Standard Strength Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-volume Strength Training</intervention_name>
    <description>Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined a low-volume strength training program:&#xD;
5 strength training exercises (chest, upper/lower back, abdominals, legs)&#xD;
1 set per exercise&#xD;
time-effort per session: ~20 min&#xD;
2 training sessions per week&#xD;
duration of exercise intervention: 12 weeks</description>
    <arm_group_label>Low-volume Strength Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whole-Body Electromyostimulation (WB-EMS)</intervention_name>
    <description>Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with WB-EMS:&#xD;
time-effort per session: ~20 min&#xD;
duration of exercise intervention: 12 weeks</description>
    <arm_group_label>Whole-body Electromyostimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index &gt;25&#xD;
&#xD;
          -  presence of at least 2 cardiometabolic risk factors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthy persons or patients under age&#xD;
&#xD;
          -  Overweight persons without any additional cardiometabolic risk factors&#xD;
&#xD;
          -  Pregnancy, Lactation&#xD;
&#xD;
          -  Psychological disorders, epilepsy, sever neurological disorders&#xD;
&#xD;
          -  Participation in other exercise- or nutrition studies within the last 6 months&#xD;
&#xD;
          -  acute cardiovascular disease&#xD;
&#xD;
          -  malignant disease&#xD;
&#xD;
          -  Rheuma&#xD;
&#xD;
          -  Intake of anabolic drugs,&#xD;
&#xD;
          -  Skin injuries in the area of electrode placements&#xD;
&#xD;
          -  Electronic implants (defibrillator, pacemaker)&#xD;
&#xD;
          -  Persons in mental hospitals by order of authorities or jurisdiction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dejan Reljic, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Erlangen Nuremberg Medical School</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yurdaguel Zopf, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Erlangen Nuremberg Medical School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dejan Reljic, Dr.</last_name>
    <phone>+49 9131 8545218</phone>
    <email>dejan.reljic@uk-erlangen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yurdaguel Zopf, Prof.</last_name>
    <phone>+49 9131 8545218</phone>
    <email>yurdaguel.zopf@uk-erlangen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,</name>
      <address>
        <city>Erlangen</city>
        <zip>91052</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dejan Reljic, Dr.</last_name>
      <phone>+49 9131 8545218</phone>
      <email>dejan.reljic@uk-erlangen.de</email>
    </contact>
    <contact_backup>
      <last_name>Yurdaguel Zopf, Prof.</last_name>
      <phone>+49 9131 8545218</phone>
      <email>yurdaguel.zopf@uk-erlangen.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Strength Training</keyword>
  <keyword>Health Promotion</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Body Composition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Metabolic Syndrome</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/NCT03306056
org study id: EKAM-Study
nct id: NCT03306056
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to compare the effects of whole-body electromyostimulation
      versus a conventional low-volume strength-training program, each combined with an
      individualized, weight-reducing diet, on the cardiometabolic risk profile, muscle strength,
      body composition, inflammatory markers and subjective health outcomes in overweight
      individuals at increased cardiometabolic risk.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: parallel-group, randomized-controlled study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking).
measure: Metabolic Syndrome Z-Score (MetS-Z-Score)
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: MetS-Z-Score will be calculated from each individual's measures of waist circumference, mean arterial blood pressure, triglycerides, and HDL-cholesterol, based on equations specific to sex.
measure: Muscle strength
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Muscle strength of the five major muscle groups (chest, upper back, lower back, abdominals, legs) will be assessed by using specific strength-training devices (Butterfly, Pull-down, Hyperextension, Abdominal Crunch, Leg-Press)
measure: Body Composition
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)
measure: Cardiorespiratory Fitness (CRF)
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)
measure: Inflammation status
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Inflammation will be assessed by measuring Levels of CRP and inflammatory cytokines and other inflammatory blood markers
measure: Health-related quality of life
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire
measure: Pain scores
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)
measure: Perceived stress
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)
measure: Subjective work ability
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)
arm group label: Control
arm group type: Experimental
description: Nutritional therapy / no exercise
arm group label: Standard Strength Training
arm group type: Experimental
description: Nutritional therapy combined with a Standard Strength Training program
arm group label: Low-volume Strength Training
arm group type: Experimental
description: Nutritional therapy combined with a low-volume Strength Training program
arm group label: Whole-body Electromyostimulation
arm group type: Experimental
description: Nutritional therapy combined with Whole-Body Electromyostimulation
intervention type: Other
intervention name: Control
description: Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks
arm group label: Control
intervention type: Other
intervention name: Standard Strength Training
description: Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with a standard strength training program:
5 strength training exercises (chest, upper/lower back, abdominals, legs)
3 sets per exercise
time-effort per session: ~90 min
2 training sessions per week
duration of exercise intervention: 12 weeks
arm group label: Standard Strength Training
intervention type: Other
intervention name: Low-volume Strength Training
description: Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined a low-volume strength training program:
5 strength training exercises (chest, upper/lower back, abdominals, legs)
1 set per exercise
time-effort per session: ~20 min
2 training sessions per week
duration of exercise intervention: 12 weeks
arm group label: Low-volume Strength Training
intervention type: Other
intervention name: Whole-Body Electromyostimulation (WB-EMS)
description: Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with WB-EMS:
time-effort per session: ~20 min
duration of exercise intervention: 12 weeks
arm group label: Whole-body Electromyostimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dejan Reljic, Dr.
role: Principal Investigator
affiliation: University Erlangen Nuremberg Medical School
last name: Yurdaguel Zopf, Prof.
role: Principal Investigator
affiliation: University Erlangen Nuremberg Medical School
last name: Dejan Reljic, Dr.
phone: +49 9131 8545218
email: dejan.reljic@uk-erlangen.de
last name: Yurdaguel Zopf, Prof.
phone: +49 9131 8545218
email: yurdaguel.zopf@uk-erlangen.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Sponsor
mesh term: Overweight
mesh term: Metabolic Syndrome