<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/NCT04496323</url>
  </required_header>
  <id_info>
    <org_study_id>EE_Golf</org_study_id>
    <nct_id>NCT04496323</nct_id>
  </id_info>
  <brief_title>Energy Expenditure in Golf</brief_title>
  <official_title>Physical Activity and Energy Expenditure in Golf</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hannover Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hannover 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>
      Structured exercise and physical activity are well known to not only improve physical&#xD;
      fitness, but also alter various health parameters in a positive fashion. To yield health&#xD;
      benefits, exercises need to meet certain characteristics e. g. specific levels of intensity&#xD;
      or duration.To evaluate intensity levels and therefor possible improvements in physical&#xD;
      conditioning in golf the investigators conducted this study with two groups of each 10&#xD;
      subjects. The groups differed in age and skill level (handicap, hcp). Each group went through&#xD;
      a exercise session on the driving range (DR) and a 9-hole compeition round of golf. The&#xD;
      investigators assessed spirometrical data (breath-by-breath) to evaluate energy expenditure&#xD;
      (EE) and intensity levels of physical activity according to the ACSM guidelines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">November 30, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Metabolic Äquivalent of Task (MET)</measure>
    <time_frame>90 minutes</time_frame>
    <description>1 MET = 3.5 mL of oxygen per kilogram bodyweight per minute</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Heart Rate</measure>
    <time_frame>90 minutes</time_frame>
    <description>Heartrate in in relation to maximum heartrate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent VO2</measure>
    <time_frame>90 minutes</time_frame>
    <description>oxygen uptake in relation maximum oxygen uptake (VO2peak)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Intensity levels in METs</measure>
    <time_frame>90 minutes</time_frame>
    <description>Relative time spent in intensity levels</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>LOW</arm_group_label>
    <description>Golf Skill level high, handicap below 11.5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIGH</arm_group_label>
    <description>Golf Skill level low, handicap 18.5 - 26.4</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EE Golf</intervention_name>
    <description>Exercise in Golf and Playing 9 holes</description>
    <arm_group_label>HIGH</arm_group_label>
    <arm_group_label>LOW</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Members of German golf clubs with an active playing status.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male&#xD;
&#xD;
          -  age 18 to 45 y&#xD;
&#xD;
          -  Body-Mass-Index: under 30 kg/m2&#xD;
&#xD;
          -  Handicapclasses 1,2 und 4&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication (orthopaedic, cardiologic, etc.) to participating in physical&#xD;
             exhausting force and endurance testing and playing golf&#xD;
&#xD;
          -  acute or chronical inflammation&#xD;
&#xD;
          -  intake of drugs and medication&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uwe Tegtbur, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Hannover Medical School</affiliation>
  </overall_official>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Golf</keyword>
  <keyword>Exercise</keyword>
  <keyword>Energy consumption</keyword>
  <keyword>METs</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04496323
org study id: EE_Golf
nct id: NCT04496323
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Structured exercise and physical activity are well known to not only improve physical
      fitness, but also alter various health parameters in a positive fashion. To yield health
      benefits, exercises need to meet certain characteristics e. g. specific levels of intensity
      or duration.To evaluate intensity levels and therefor possible improvements in physical
      conditioning in golf the investigators conducted this study with two groups of each 10
      subjects. The groups differed in age and skill level (handicap, hcp). Each group went through
      a exercise session on the driving range (DR) and a 9-hole compeition round of golf. The
      investigators assessed spirometrical data (breath-by-breath) to evaluate energy expenditure
      (EE) and intensity levels of physical activity according to the ACSM guidelines.
observational model: Cohort
time perspective: Cross-Sectional
measure: Metabolic Äquivalent of Task (MET)
time frame: 90 minutes
description: 1 MET = 3.5 mL of oxygen per kilogram bodyweight per minute
measure: Percent Heart Rate
time frame: 90 minutes
description: Heartrate in in relation to maximum heartrate
measure: Percent VO2
time frame: 90 minutes
description: oxygen uptake in relation maximum oxygen uptake (VO2peak)
measure: Duration of Intensity levels in METs
time frame: 90 minutes
description: Relative time spent in intensity levels
arm group label: LOW
description: Golf Skill level high, handicap below 11.5
arm group label: HIGH
description: Golf Skill level low, handicap 18.5 - 26.4
intervention type: Other
intervention name: EE Golf
description: Exercise in Golf and Playing 9 holes
arm group label: HIGH
arm group label: LOW
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Uwe Tegtbur, Prof.
role: Study Director
affiliation: Hannover Medical School
responsible party type: Sponsor
sharing ipd: Undecided