<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/NCT03284450</url>
  </required_header>
  <id_info>
    <org_study_id>NUMB1</org_study_id>
    <nct_id>NCT03284450</nct_id>
  </id_info>
  <brief_title>Exercise Induced Muscle Damage Post Dance and Sprint Specific Exercise in Females</brief_title>
  <official_title>Exercise Induced Muscle Damage Post Dance and Sprint Specific Exercise in Females</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northumbria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northumbria University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a paucity of studies investigating exercise-induced muscle damage (EIMD) in females&#xD;
      and only one in response to dance-type exercise. This study aimed to firstly elucidate the&#xD;
      physiological profile of EIMD following a dance-specific protocol, and second to compare the&#xD;
      magnitude of damage to that experienced following a sport-specific protocol in physically&#xD;
      active females.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty nine female recreational dancers from a University dance team volunteered to take part&#xD;
      in the study. A 3-day food diary and activity log completed prior to testing determined that&#xD;
      there were no differences in physical activity levels or energy and macronutrient intakes&#xD;
      between participants. Subjects were asked to replicate their reported diets as closely as&#xD;
      possible throughout the testing period. A menstrual cycle questionnaire was also completed in&#xD;
      order to determine menstrual cycle phase; all testing took place during the early/mid luteal&#xD;
      phase.&#xD;
&#xD;
      Participants were randomly assigned to two exercise groups designed to induce EIMD; either a&#xD;
      dance-specific protocol (DPFT) or a sport-specific repeated sprint protocol (SSRS).&#xD;
      Participants completed the DPFT (n=15) or SSRS (n=14) and a battery of commonly used muscle&#xD;
      damage indices were measured pre, immediately post and 24-, 48-, and 72 h post muscle damage.&#xD;
      These were; delayed onset muscle soreness (DOMS), limb girth, countermovement jump height&#xD;
      (CMJ), reactive strength index (RSI), maximal voluntary isometric contraction (MVC) sprint&#xD;
      performance, and total creatine kinase (CK) activity. Participants were tested at the same&#xD;
      time on subsequent days (± 1 h) to account for diurnal variation. Participants were asked to&#xD;
      avoid strenuous exercise, alcohol, caffeine, nutritional supplements and any&#xD;
      anti-inflammatory drugs or alternative treatments for the duration of the study.&#xD;
&#xD;
      Statistical software (IBM SPSS v21, IBM, USA) was used for inferential analysis and&#xD;
      significance was accepted at the P &lt; .05 a priori. Mauchley's test assessed the sphericity of&#xD;
      the data and where appropriate, violations were corrected using the Greenhouse-Geisser. To&#xD;
      explore our first objective, a one-way analysis of variance (ANOVA) with repeated measures&#xD;
      (group, 1; time, 5) was performed on all variables in order to analyse the muscle damage&#xD;
      response to the DPFT. For the second aim a two-way ANOVA with repeated measures (group, 2;&#xD;
      time, 5) was used for all variables to allow for comparison of the muscle damage response&#xD;
      between the DPFT and the SSRS. Where appropriate LSD post-hoc analysis was performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in maximum voluntary contraction (MVC)</measure>
    <time_frame>Change from pre exercise MVC at 24 h post exercise</time_frame>
    <description>Isometric MVC of the participants' dominant knee extensors was assessed using a strain gauge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Limb girths</measure>
    <time_frame>pre, immediately post (0) and 24-, 48-, and 72 h post exercise</time_frame>
    <description>Lower limb girths at the calf and mid-thigh of the right leg were recorded as measures of muscle swelling. Both locations were marked with permanent marker to ensure consistency on consecutive days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Countermovement jump</measure>
    <time_frame>pre, immediately post (0) and 24-, 48-, and 72 h post exercise</time_frame>
    <description>Countermovement jump height was recorded using a light timing system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactive strength index</measure>
    <time_frame>pre, immediately post (0) and 24-, 48-, and 72 h post exercise</time_frame>
    <description>Participants performed a drop jump from a 30cm height to determine reactive strength index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle soreness</measure>
    <time_frame>pre, immediately post (0) and 24-, 48-, and 72 h post exercise</time_frame>
    <description>Subjective muscle soreness was measured using a 200 mm visual analogue scale from 'no soreness' to 'unbearably sore.' Participants were required to indicate on the line the level of perceived active lower limb soreness felt during a 90 degree squat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 m sprint time</measure>
    <time_frame>pre, immediately post (0) and 24-, 48-, and 72 h post exercise</time_frame>
    <description>Participants completed a single maximal effort 30 m sprint where sprint time was recorded. The sprint was initiated from a line 30 cm behind the start line in order to prevent false triggering of the timing gates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatine Kinase</measure>
    <time_frame>pre, immediately post (0) and 24-, 48-, and 72 h post exercise</time_frame>
    <description>Blood samples were collected via venepuncture from the antecubital fossa area in to a 10 ml EDTA vacutainer. The samples were centrifuged at 3000 RCF for 15 minutes at 4 C. Plasma was extracted, and stored immediately at -80 C for later analysis. Plasma CK concentrations were determined spectrophotometrically.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Exercise Induced Muscle Damage</condition>
  <arm_group>
    <arm_group_label>Dance performance fitness test (DPFT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sport specific repeated sprints (SSRS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DPFT</intervention_name>
    <description>The DPFT described previously (Redding et al., 2009) involves the repetition of a 'dance phrase' representative of contemporary dance, with each phrase separated by a 2 minute rest period. For the present study the originally described test was extended; the adapted protocol involved 10 x 1 minute movement phrases, each separated by 2 minutes rest.</description>
    <arm_group_label>Dance performance fitness test (DPFT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SSRS</intervention_name>
    <description>The SSRS (Howatson &amp; Milak, 2009) involved 15 x 30 m sprints with a rapid 10 m deceleration phase, with each sprint departing every 65 seconds.</description>
    <arm_group_label>Sport specific repeated sprints (SSRS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  physically active&#xD;
&#xD;
          -  at least 3 years experience in dance training&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of any medical or physical conditions, either chronic or sustained in the&#xD;
             last 3 months which would make participation difficult or harmful to the participant&#xD;
&#xD;
          -  eg. history of cardiovascular disease and musculoskeletal disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emma J Stevenson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northumbria University</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 28, 2016</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northumbria University</investigator_affiliation>
    <investigator_full_name>Glyn Howatson</investigator_full_name>
    <investigator_title>Reader - Human and Applied Physiology</investigator_title>
  </responsible_party>
  <keyword>Dance</keyword>
  <keyword>Sprint</keyword>
  <keyword>Females</keyword>
  <keyword>Recovery</keyword>
  <!-- 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/NCT03284450
org study id: NUMB1
nct id: NCT03284450
lead sponsor: 
has dmc: No
There is a paucity of studies investigating exercise-induced muscle damage (EIMD) in females
      and only one in response to dance-type exercise. This study aimed to firstly elucidate the
      physiological profile of EIMD following a dance-specific protocol, and second to compare the
      magnitude of damage to that experienced following a sport-specific protocol in physically
      active females.
Twenty nine female recreational dancers from a University dance team volunteered to take part
      in the study. A 3-day food diary and activity log completed prior to testing determined that
      there were no differences in physical activity levels or energy and macronutrient intakes
      between participants. Subjects were asked to replicate their reported diets as closely as
      possible throughout the testing period. A menstrual cycle questionnaire was also completed in
      order to determine menstrual cycle phase; all testing took place during the early/mid luteal
      phase.

      Participants were randomly assigned to two exercise groups designed to induce EIMD; either a
      dance-specific protocol (DPFT) or a sport-specific repeated sprint protocol (SSRS).
      Participants completed the DPFT (n=15) or SSRS (n=14) and a battery of commonly used muscle
      damage indices were measured pre, immediately post and 24-, 48-, and 72 h post muscle damage.
      These were; delayed onset muscle soreness (DOMS), limb girth, countermovement jump height
      (CMJ), reactive strength index (RSI), maximal voluntary isometric contraction (MVC) sprint
      performance, and total creatine kinase (CK) activity. Participants were tested at the same
      time on subsequent days (± 1 h) to account for diurnal variation. Participants were asked to
      avoid strenuous exercise, alcohol, caffeine, nutritional supplements and any
      anti-inflammatory drugs or alternative treatments for the duration of the study.

      Statistical software (IBM SPSS v21, IBM, USA) was used for inferential analysis and
      significance was accepted at the P < .05 a priori. Mauchley's test assessed the sphericity of
      the data and where appropriate, violations were corrected using the Greenhouse-Geisser. To
      explore our first objective, a one-way analysis of variance (ANOVA) with repeated measures
      (group, 1; time, 5) was performed on all variables in order to analyse the muscle damage
      response to the DPFT. For the second aim a two-way ANOVA with repeated measures (group, 2;
      time, 5) was used for all variables to allow for comparison of the muscle damage response
      between the DPFT and the SSRS. Where appropriate LSD post-hoc analysis was performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in maximum voluntary contraction (MVC)
time frame: Change from pre exercise MVC at 24 h post exercise
description: Isometric MVC of the participants' dominant knee extensors was assessed using a strain gauge.
measure: Limb girths
time frame: pre, immediately post (0) and 24-, 48-, and 72 h post exercise
description: Lower limb girths at the calf and mid-thigh of the right leg were recorded as measures of muscle swelling. Both locations were marked with permanent marker to ensure consistency on consecutive days.
measure: Countermovement jump
time frame: pre, immediately post (0) and 24-, 48-, and 72 h post exercise
description: Countermovement jump height was recorded using a light timing system.
measure: Reactive strength index
time frame: pre, immediately post (0) and 24-, 48-, and 72 h post exercise
description: Participants performed a drop jump from a 30cm height to determine reactive strength index
measure: Muscle soreness
time frame: pre, immediately post (0) and 24-, 48-, and 72 h post exercise
description: Subjective muscle soreness was measured using a 200 mm visual analogue scale from 'no soreness' to 'unbearably sore.' Participants were required to indicate on the line the level of perceived active lower limb soreness felt during a 90 degree squat.
measure: 30 m sprint time
time frame: pre, immediately post (0) and 24-, 48-, and 72 h post exercise
description: Participants completed a single maximal effort 30 m sprint where sprint time was recorded. The sprint was initiated from a line 30 cm behind the start line in order to prevent false triggering of the timing gates.
measure: Creatine Kinase
time frame: pre, immediately post (0) and 24-, 48-, and 72 h post exercise
description: Blood samples were collected via venepuncture from the antecubital fossa area in to a 10 ml EDTA vacutainer. The samples were centrifuged at 3000 RCF for 15 minutes at 4 C. Plasma was extracted, and stored immediately at -80 C for later analysis. Plasma CK concentrations were determined spectrophotometrically.
arm group label: Dance performance fitness test (DPFT)
arm group type: Experimental
arm group label: Sport specific repeated sprints (SSRS)
arm group type: Active Comparator
intervention type: Other
intervention name: DPFT
description: The DPFT described previously (Redding et al., 2009) involves the repetition of a 'dance phrase' representative of contemporary dance, with each phrase separated by a 2 minute rest period. For the present study the originally described test was extended; the adapted protocol involved 10 x 1 minute movement phrases, each separated by 2 minutes rest.
arm group label: Dance performance fitness test (DPFT)
intervention type: Other
intervention name: SSRS
description: The SSRS (Howatson & Milak, 2009) involved 15 x 30 m sprints with a rapid 10 m deceleration phase, with each sprint departing every 65 seconds.
arm group label: Sport specific repeated sprints (SSRS)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emma J Stevenson, PhD
role: Principal Investigator
affiliation: Northumbria University
responsible party type: Principal Investigator
investigator affiliation: Northumbria University
investigator full name: Glyn Howatson
investigator title: Reader - Human and Applied Physiology