<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/NCT04439734</url>
  </required_header>
  <id_info>
    <org_study_id>GOLFEMS III</org_study_id>
    <nct_id>NCT04439734</nct_id>
  </id_info>
  <brief_title>Effects of Whole-body Electromyostimulation on Golf Performance in Amateur Golfers</brief_title>
  <official_title>Effects of Whole-body Electromyostimulation on Clubhead Speed and Stability in Ambitious Amateur Golfers - a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Golfersworld München</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Golfclub München-Eichenried</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</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>
      Golf is becoming increasingly popular in Germany. However, the biomechanical and motor&#xD;
      challenge of golf should not be underestimated. Nevertheless, only very few amateur golfers&#xD;
      carry out serious preparation and conditioning as part of a strength/stabilization program.&#xD;
      The main argument for this limitation is the aspect of &quot;limited time resources&quot;. A solution&#xD;
      to this problem could therefore be the time-effective and highly individualizable whole-body&#xD;
      electromyostimulation (WB-EMS) technology.&#xD;
&#xD;
      The aim of the present study is to evaluate the effectiveness of 16 weeks of WB-EMS&#xD;
      application on trunk stability and clubhead speed in male amateur golfers in a (randomized)&#xD;
      controlled setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">October 31, 2022</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>Randomized controlled trial with two study groups in parallel: (1) Whole body electromyostimulation (WB-EMS) or 16 weeks (b) non WB-EMS control</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Outcomes assessor were unaware of participants status (i.e. WB-EMS or control) and were not allowed to ask correspondingly</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clubhead speed</measure>
    <time_frame>At baseline and after16 weeks (i.e. over 16 weeks)</time_frame>
    <description>Changes of clubhead speed as determined by a radar-based system (&quot;TrackMan&quot;, Scottsdale, USA)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trunk stability as determined by</measure>
    <time_frame>At baseline and after16 weeks (i.e. over 16 weeks)</time_frame>
    <description>Changes of maximum isometric trunk strength (index of trunk extension/-flexion; lateral flexion and trunk rotation) as determined by an isometric testing device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clubhead speed</measure>
    <time_frame>At baseline and after 8 weeks (i.e. over 8 weeks)</time_frame>
    <description>Changes of clubhead speed as determined by a radar-based system (&quot;TrackMan&quot;, Scottsdale, USA)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Athletic Performance</condition>
  <arm_group>
    <arm_group_label>Whole-Body Electromyostimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>WB-EMS once per week for for 16 week (85 Hz, 350 µs, bipolar, duty cycle 4s-4s)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non WB-EMS control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No WB intervention, but maintained physical activity and habitual exercise habits</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electromyostimulation</intervention_name>
    <description>WB-EMS once per week 20 min for 16 weeks</description>
    <arm_group_label>Whole-Body Electromyostimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Golfhandicap ≤20,&#xD;
&#xD;
          -  members of the Golfclub München-Eichenried&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diseases and medication that did not allow WB-EMS training (see contraindications&#xD;
             WB-EMS) or enable proper assessment of clubhead speed (in cases of doubt, individual&#xD;
             medical decision),&#xD;
&#xD;
          -  resistance and/or WB-EMS Training during the last 6 months,&#xD;
&#xD;
          -  more than two expected missed WB-EMS sessions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Medical Physics, Friedrich-Alexanden University Erlangen-Nürnberg</name>
      <address>
        <city>Erlangen</city>
        <zip>91052</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Zink C, Rückel F, von Stengel S, Kemmler W. The Use of Whole Body Electromyostimulation (WB-EMS) as a Golf Warm-Up - A Randomized Controlled Cross-Over Study. Archives of Physical Health and Sports Medicine 2019; 2(1)1: 04-12</citation>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data that support the findings of this study are available on request from the corresponding author (WK)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will become available in January 2021 without time limit</ipd_time_frame>
  </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/NCT04439734
org study id: GOLFEMS III
nct id: NCT04439734
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Golf is becoming increasingly popular in Germany. However, the biomechanical and motor
      challenge of golf should not be underestimated. Nevertheless, only very few amateur golfers
      carry out serious preparation and conditioning as part of a strength/stabilization program.
      The main argument for this limitation is the aspect of "limited time resources". A solution
      to this problem could therefore be the time-effective and highly individualizable whole-body
      electromyostimulation (WB-EMS) technology.

      The aim of the present study is to evaluate the effectiveness of 16 weeks of WB-EMS
      application on trunk stability and clubhead speed in male amateur golfers in a (randomized)
      controlled setting.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial with two study groups in parallel: (1) Whole body electromyostimulation (WB-EMS) or 16 weeks (b) non WB-EMS control
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
masking description: Outcomes assessor were unaware of participants status (i.e. WB-EMS or control) and were not allowed to ask correspondingly
measure: Clubhead speed
time frame: At baseline and after16 weeks (i.e. over 16 weeks)
description: Changes of clubhead speed as determined by a radar-based system ("TrackMan", Scottsdale, USA)
measure: Trunk stability as determined by
time frame: At baseline and after16 weeks (i.e. over 16 weeks)
description: Changes of maximum isometric trunk strength (index of trunk extension/-flexion; lateral flexion and trunk rotation) as determined by an isometric testing device
measure: Clubhead speed
time frame: At baseline and after 8 weeks (i.e. over 8 weeks)
description: Changes of clubhead speed as determined by a radar-based system ("TrackMan", Scottsdale, USA)
arm group label: Whole-Body Electromyostimulation
arm group type: Experimental
description: WB-EMS once per week for for 16 week (85 Hz, 350 µs, bipolar, duty cycle 4s-4s)
arm group label: Non WB-EMS control
arm group type: No Intervention
description: No WB intervention, but maintained physical activity and habitual exercise habits
intervention type: Device
intervention name: Electromyostimulation
description: WB-EMS once per week 20 min for 16 weeks
arm group label: Whole-Body Electromyostimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
citation: Zink C, Rückel F, von Stengel S, Kemmler W. The Use of Whole Body Electromyostimulation (WB-EMS) as a Golf Warm-Up - A Randomized Controlled Cross-Over Study. Archives of Physical Health and Sports Medicine 2019; 2(1)1: 04-12
responsible party type: Sponsor
sharing ipd: Yes
ipd description: The data that support the findings of this study are available on request from the corresponding author (WK)
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will become available in January 2021 without time limit