<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/NCT03275779</url>
  </required_header>
  <id_info>
    <org_study_id>ERN_17-0997</org_study_id>
    <nct_id>NCT03275779</nct_id>
  </id_info>
  <brief_title>Investigating the Role of Resistance Exercise Frequency in the Regulation of Skeletal Muscle Mass</brief_title>
  <acronym>EXFREQ</acronym>
  <official_title>Investigating the Role of Resistance Exercise Frequency in the Regulation of Skeletal Muscle Mass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maastricht University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Birmingham</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>
      This study will investigate whether manipulating resistance exercise frequency impacts muscle&#xD;
      protein synthesis rates. The investigators will test the hypothesise that a higher resistance&#xD;
      exercise frequency will result in greater muscle protein synthesis rates than a lower&#xD;
      resistance exercise frequency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Resistance exercise is currently the most effective means of building or maintaining muscle&#xD;
      mass. Resistance exercise guidelines generally suggest that those looking to increase muscle&#xD;
      mass should train each muscle group once to twice per week. However, it has been proposed&#xD;
      that it may be of greater benefit to train a muscle group with a higher frequency (i.e., four&#xD;
      to six times per week) than currently suggested. If true, completing the same total volume of&#xD;
      resistance exercise in more frequent, smaller bouts could prove to be a more beneficial&#xD;
      strategy to optimally build or maintain muscle mass.&#xD;
&#xD;
      Therefore, this study will investigate whether manipulating resistance exercise frequency&#xD;
      impacts cumulative muscle protein synthesis rates in young individuals. Participants will&#xD;
      undergo a 7 day period of habitual activity before completing the same total volume of&#xD;
      resistance exercise as either; i) one isolated bout (low frequency) or ii) five smaller bouts&#xD;
      (high frequency) over a period of 7 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in muscle protein synthesis (FSR %/day)</measure>
    <time_frame>At day 10 and 15.</time_frame>
    <description>The change in muscle protein synthesis rates (FSR %/day) from baseline will be determined between the low and high frequency conditions at days 10 and 15 using deuterium oxide (D2O).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in satellite cell response</measure>
    <time_frame>At day 10 and 15.</time_frame>
    <description>The change in acute satellite cell response will be determined in muscle samples following low and high frequency resistance exercise at days 10 and 15.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Low Frequency Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete a single bout of unilateral resistance exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Frequency Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete the same total volume of resistance exercise as the low frequency condition as five smaller bouts of unilateral resistance exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Low Frequency Condition</intervention_name>
    <description>Young, untrained participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete a single bout of unilateral resistance exercise.</description>
    <arm_group_label>Low Frequency Condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High Frequency Condition</intervention_name>
    <description>Young, untrained participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete the same total volume of resistance exercise as the low frequency condition as five smaller bouts of unilateral resistance exercise.</description>
    <arm_group_label>High Frequency Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (18.5-29.99 kg/m2)&#xD;
&#xD;
          -  Untrained - defined as: Perform activities of daily living and recreation but have&#xD;
             completed no regular lower body resistance-type exercise (e.g., weight training)&#xD;
             activity in the last year.&#xD;
&#xD;
          -  Good general health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lidocaine allergy&#xD;
&#xD;
          -  Hypertension (≥140/90 mmHg)&#xD;
&#xD;
          -  Current participation in another clinical study&#xD;
&#xD;
          -  Previous participation in this study&#xD;
&#xD;
          -  Bleeding disorder/s&#xD;
&#xD;
          -  Current or recent smoker&#xD;
&#xD;
          -  Vegetarian or vegan&#xD;
&#xD;
          -  Past history of substance abuse and/or taking prescription or non-prescription&#xD;
             medication (e.g., beta-blockers, insulin or thyroxine) or supplements that may&#xD;
             influence normal metabolic responses.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participants must be male.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gareth Wallis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Sport Exercise and Rehabilitation Sciences, University of Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2TT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03275779
org study id: ERN_17-0997
nct id: NCT03275779
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will investigate whether manipulating resistance exercise frequency impacts muscle
      protein synthesis rates. The investigators will test the hypothesise that a higher resistance
      exercise frequency will result in greater muscle protein synthesis rates than a lower
      resistance exercise frequency.
Resistance exercise is currently the most effective means of building or maintaining muscle
      mass. Resistance exercise guidelines generally suggest that those looking to increase muscle
      mass should train each muscle group once to twice per week. However, it has been proposed
      that it may be of greater benefit to train a muscle group with a higher frequency (i.e., four
      to six times per week) than currently suggested. If true, completing the same total volume of
      resistance exercise in more frequent, smaller bouts could prove to be a more beneficial
      strategy to optimally build or maintain muscle mass.

      Therefore, this study will investigate whether manipulating resistance exercise frequency
      impacts cumulative muscle protein synthesis rates in young individuals. Participants will
      undergo a 7 day period of habitual activity before completing the same total volume of
      resistance exercise as either; i) one isolated bout (low frequency) or ii) five smaller bouts
      (high frequency) over a period of 7 days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in muscle protein synthesis (FSR %/day)
time frame: At day 10 and 15.
description: The change in muscle protein synthesis rates (FSR %/day) from baseline will be determined between the low and high frequency conditions at days 10 and 15 using deuterium oxide (D2O).
measure: Change in satellite cell response
time frame: At day 10 and 15.
description: The change in acute satellite cell response will be determined in muscle samples following low and high frequency resistance exercise at days 10 and 15.
arm group label: Low Frequency Condition
arm group type: Experimental
description: Participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete a single bout of unilateral resistance exercise.
arm group label: High Frequency Condition
arm group type: Experimental
description: Participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete the same total volume of resistance exercise as the low frequency condition as five smaller bouts of unilateral resistance exercise.
intervention type: Behavioral
intervention name: Low Frequency Condition
description: Young, untrained participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete a single bout of unilateral resistance exercise.
arm group label: Low Frequency Condition
intervention type: Behavioral
intervention name: High Frequency Condition
description: Young, untrained participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete the same total volume of resistance exercise as the low frequency condition as five smaller bouts of unilateral resistance exercise.
arm group label: High Frequency Condition
criteria: 
gender: Male
gender based: Yes
gender description: Participants must be male.
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gareth Wallis, PhD
role: Principal Investigator
affiliation: University of Birmingham
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No