<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/NCT03298789</url>
  </required_header>
  <id_info>
    <org_study_id>UP-FVZ-StretchingEffects</org_study_id>
    <nct_id>NCT03298789</nct_id>
  </id_info>
  <brief_title>Acute Effects of Static Stretching in Warm-up</brief_title>
  <acronym>AESSW</acronym>
  <official_title>Acute Effects of Static Stretching in Warm-up on Muscular Performance of Football Players</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Primorska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>S2P, Science to Practice, Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Motus Melior, Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Primorska</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>
      In this study the investigators want to address acute effects of warm-up and static&#xD;
      stretching on short-term muscular performance of football players. Static stretching&#xD;
      exercises are often used in the first part of a training session or before a football match&#xD;
      in order to increase sports performance and to decrease risk of injuries. Since there is a&#xD;
      lot of scientific evidence that demonstrates static stretching can improve short-term muscle&#xD;
      performance, the aim of researchers is to discover the size and the duration of negative&#xD;
      effects and, additionally, whether these effects can be eliminated with activation exercises.&#xD;
      Nineteen 14 years old football players will be included in a cross-over study design.&#xD;
&#xD;
      In the control condition the participants will perform 5 minutes of aerobic warm-up (stepping&#xD;
      on the stair) and then 7 series of 20-seconds static stretching of quadriceps femoris,&#xD;
      hamstrings, hip adductors and triceps surae.&#xD;
&#xD;
      Maximal power and jump height of the countermovement jump will be tested in between every&#xD;
      series. Thus, parameters of countermovement jump will be monitored at the beginning, after&#xD;
      warm-up, after each series of static stretching, 7.5 minutes after 7th static stretching&#xD;
      series and 15 minutes after 7th static stretching series.&#xD;
&#xD;
      Parameters of dynamometry (relative maximal torque [Nm/kgBM] and rate of torque developement&#xD;
      [Nm/s/kgBM] will be monitored at the beginning, after warm up, 7.5 minutes after last series&#xD;
      of static stretching and 15 minutes after last series of static stretching.&#xD;
&#xD;
      Maximal range of motion will be monitored at the beginning, after warm up, during every&#xD;
      series of static stretching, after last series of static stretching, 7.5 minutes after last&#xD;
      series of static stretching and 15 minutes after last series of static stretching.&#xD;
&#xD;
      In the second condition (experimental) all the tasks are the same, the only difference is&#xD;
      that the subjects must perform post-activation potentiation exercises after last series of&#xD;
      static stretching.&#xD;
&#xD;
      We hypothesize that muscular performance will be impaired to a statistically significant&#xD;
      level after 7th series of static stretching. Second hypothesis is that negative effects will&#xD;
      not last longer than 15 minutes and the last hypothesis is that static stretching induced&#xD;
      negative effects can be nullified with activation exercises.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stretching exercises are often used in warm-up to increase footballer's performance and to&#xD;
      decrease risk of injury. The main aim of these exercises is to increase maximal active range&#xD;
      of motion. Different types of stretching exercises are being used: ballistic, dynamic,&#xD;
      static, eccentric flexibility training and proprioceptive neuromuscular facilitation. All of&#xD;
      them are usually used in football training sessions in order to increase short-term range of&#xD;
      motion and to decrease associated risk of injuries. Simic, Sarabon and Markovic (2013) in&#xD;
      their meta-analysis reported that static stretching can have negative acute effects, which is&#xD;
      not in line with general thinking, that static stretching in warm-up can have positive&#xD;
      effects on sports performance.&#xD;
&#xD;
      Post-activation potentiation is a phenomenon, which is induced by loading the muscle to&#xD;
      increase the recruitment of motor units. Since static stretching can have negative effects on&#xD;
      muscle performance (maximal strength, power) the researchers hypothesize, that the effects&#xD;
      can be eliminated with this type of activation exercises.&#xD;
&#xD;
      In this study the researchers want to measure acute effects of warm-up and static stretching&#xD;
      on maximal range of motion, maximal torque and maximal rate of torque of adductors&#xD;
      (dynamometer) and maximal power and height of countermovement jump (force plate) of football&#xD;
      players. Since there is many scientific evidence that shows that static stretching can&#xD;
      improve short-term muscle performance, our aim is to discover the size and the duration of&#xD;
      negative effects and if they can be eliminated with post-activation potentiation exercises.&#xD;
      In the cross-over study design 19 football players of age 14 will be included.&#xD;
&#xD;
      In the first condition (control) the participants will perform 5 minutes of aerobic warm-up&#xD;
      (stepping on the stair) and then 7 series of 20-seconds bilateral static stretching of&#xD;
      hamstrings, adductors and triceps surae (with knee extended). Quadriceps femoris will be&#xD;
      stretched unilaterally, each muscle 20 seconds. Summary of all stretches in one series is 80&#xD;
      seconds. Maximal range of motion of hip abduction and hip flexion (seat and reach test) and&#xD;
      dorsal flexion will be measured at the beginning, after warm up, during each series of static&#xD;
      stretching, after last series of static stretching, 7.5 minutes after last series of static&#xD;
      stretching and 15 minutes after last series of static stretching.&#xD;
&#xD;
      Maximal power [W/kg] and height [m] of the countermovement jump will be monitored with force&#xD;
      plate at the beginning, after warm up, after each series of static stretching, 7.5 minutes&#xD;
      after last series of static stretching and 15 minutes after last series of static stretching.&#xD;
&#xD;
      On dynamometer will be conducted 2 maximal explosive voluntary contractions of adductors&#xD;
      muscles. Relative maximal torque [Nm/kgBM] and rate of torque developement [Nm/s/kgBM] will&#xD;
      be measured at the beginning, after warm up, after last series of static stretching, 7.5&#xD;
      minutes after last series of static stretching and 15 minutes after last series of static&#xD;
      stretching.&#xD;
&#xD;
      In the second condition (experimental) all the tasks are the same, the only difference is&#xD;
      that the subjects must conduct activation exercises after last series of static stretching.&#xD;
&#xD;
      Activation exercises are consisted of 2 series of 4 exercises. The first series (slow series)&#xD;
      starts with 8 lifts onto toes (dorsal flexion) with knees extended, than continues with 8&#xD;
      deep squats and 8 hip thrust and then terminates with four 4-seconds lasting maximal&#xD;
      voluntary contraction of adductors with knees extended and with soft ball between the ankles.&#xD;
      The second series (explosive) commences with 8 maximal vertical jumps conducted just with&#xD;
      ankles, and then continues with 8 maximal countermovement jumps and 8 explosive hip thrusts.&#xD;
      It finishes with 8 maximal explosive and 2 seconds lasting voluntary contractions of hip&#xD;
      adductors with knees extended and with soft ball between the ankles.&#xD;
&#xD;
      The researchers hypothesize that muscular performance (maximal power and height of the&#xD;
      countermovement jump, maximal torque and rate of torque developement of adductors muscles)&#xD;
      will be impaired after 7 series of static stretching. Second hypothesis is that negative&#xD;
      effects will not last longer than 15 minutes and the last hypothesis is that static&#xD;
      stretching induced negative effects can be eliminated with sets of activation exercises.&#xD;
&#xD;
      Statistical analysis will be performed in SPSS (SPSS Statistics 22, IBM, New York). T-test,&#xD;
      1-way and 2-way repeated measures ANOVA will be used to confirm the differences between&#xD;
      average values.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2017</start_date>
  <completion_date type="Actual">July 30, 2017</completion_date>
  <primary_completion_date type="Actual">July 23, 2017</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>
    <intervention_model_description>19 subjects will be devided into two groups. The first group will conduct the control condition on Saturday and the second group will conduct the experimental condition on Sunday. One week later, the subjects will undergo the second visit, each group of subjects performing the opposite condition.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle Performance</measure>
    <time_frame>1 week</time_frame>
    <description>Maximal and explosive strength of adductors, maximal power during countermovement jump</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximal power during countermovement jump</measure>
    <time_frame>1 week</time_frame>
    <description>Relative maximal power during countermovement jump on force plate (W/kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Jump Height</measure>
    <time_frame>1 week</time_frame>
    <description>Maximal height of countermovement jump on force plate (m)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative maximal torque of adductors on dynamometer (Nm/kgBM)</measure>
    <time_frame>1 week</time_frame>
    <description>Maximal voluntary contraction of adductors will be performed on dynamometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of torque developement (Nm/s/kgBM)</measure>
    <time_frame>1 week</time_frame>
    <description>Rate of torque developement were monitored during Explosive maximal voluntary contraction of adductors performed on dynamometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal range of motion (cm)</measure>
    <time_frame>1 week</time_frame>
    <description>Maximal range of passive motion (bilaterally performed: seat&amp;reach, hip abduction, dorsal foot flexion - for all, knees extended)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Only Healthy Participants Are Included in the Study</condition>
  <arm_group>
    <arm_group_label>Experimental condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 series of static stretching will be conducted in the experimental condition. Activation exercises will be performed after 7th series of static stretching.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>7 series of static stretching will be conducted in the control condition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Activation exercise</intervention_name>
    <description>Two series of 4 activation exercise will be included in the intervention.</description>
    <arm_group_label>Experimental condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>7 series of static stretching</intervention_name>
    <description>7 series of 4 20 seconds static stretches will be conducted.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Experimental condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  football players, man&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  injuries, last 12 months&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nejc Sarabon, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Primorska, Faculty of Health Studies, Izola, Slovenia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Health Studies, University of Primorska</name>
      <address>
        <city>Izola</city>
        <state>Polje 42</state>
        <zip>6310</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Primorska</investigator_affiliation>
    <investigator_full_name>Nejc Sarabon</investigator_full_name>
    <investigator_title>Assoc. Prof. Dr. Sc.</investigator_title>
  </responsible_party>
  <keyword>static stretching</keyword>
  <keyword>muscle power</keyword>
  <keyword>countermovement jump</keyword>
  <keyword>dynamometry</keyword>
  <keyword>warm up</keyword>
  <keyword>force plate</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/NCT03298789
org study id: UP-FVZ-StretchingEffects
nct id: NCT03298789
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study the investigators want to address acute effects of warm-up and static
      stretching on short-term muscular performance of football players. Static stretching
      exercises are often used in the first part of a training session or before a football match
      in order to increase sports performance and to decrease risk of injuries. Since there is a
      lot of scientific evidence that demonstrates static stretching can improve short-term muscle
      performance, the aim of researchers is to discover the size and the duration of negative
      effects and, additionally, whether these effects can be eliminated with activation exercises.
      Nineteen 14 years old football players will be included in a cross-over study design.

      In the control condition the participants will perform 5 minutes of aerobic warm-up (stepping
      on the stair) and then 7 series of 20-seconds static stretching of quadriceps femoris,
      hamstrings, hip adductors and triceps surae.

      Maximal power and jump height of the countermovement jump will be tested in between every
      series. Thus, parameters of countermovement jump will be monitored at the beginning, after
      warm-up, after each series of static stretching, 7.5 minutes after 7th static stretching
      series and 15 minutes after 7th static stretching series.

      Parameters of dynamometry (relative maximal torque [Nm/kgBM] and rate of torque developement
      [Nm/s/kgBM] will be monitored at the beginning, after warm up, 7.5 minutes after last series
      of static stretching and 15 minutes after last series of static stretching.

      Maximal range of motion will be monitored at the beginning, after warm up, during every
      series of static stretching, after last series of static stretching, 7.5 minutes after last
      series of static stretching and 15 minutes after last series of static stretching.

      In the second condition (experimental) all the tasks are the same, the only difference is
      that the subjects must perform post-activation potentiation exercises after last series of
      static stretching.

      We hypothesize that muscular performance will be impaired to a statistically significant
      level after 7th series of static stretching. Second hypothesis is that negative effects will
      not last longer than 15 minutes and the last hypothesis is that static stretching induced
      negative effects can be nullified with activation exercises.
Stretching exercises are often used in warm-up to increase footballer's performance and to
      decrease risk of injury. The main aim of these exercises is to increase maximal active range
      of motion. Different types of stretching exercises are being used: ballistic, dynamic,
      static, eccentric flexibility training and proprioceptive neuromuscular facilitation. All of
      them are usually used in football training sessions in order to increase short-term range of
      motion and to decrease associated risk of injuries. Simic, Sarabon and Markovic (2013) in
      their meta-analysis reported that static stretching can have negative acute effects, which is
      not in line with general thinking, that static stretching in warm-up can have positive
      effects on sports performance.

      Post-activation potentiation is a phenomenon, which is induced by loading the muscle to
      increase the recruitment of motor units. Since static stretching can have negative effects on
      muscle performance (maximal strength, power) the researchers hypothesize, that the effects
      can be eliminated with this type of activation exercises.

      In this study the researchers want to measure acute effects of warm-up and static stretching
      on maximal range of motion, maximal torque and maximal rate of torque of adductors
      (dynamometer) and maximal power and height of countermovement jump (force plate) of football
      players. Since there is many scientific evidence that shows that static stretching can
      improve short-term muscle performance, our aim is to discover the size and the duration of
      negative effects and if they can be eliminated with post-activation potentiation exercises.
      In the cross-over study design 19 football players of age 14 will be included.

      In the first condition (control) the participants will perform 5 minutes of aerobic warm-up
      (stepping on the stair) and then 7 series of 20-seconds bilateral static stretching of
      hamstrings, adductors and triceps surae (with knee extended). Quadriceps femoris will be
      stretched unilaterally, each muscle 20 seconds. Summary of all stretches in one series is 80
      seconds. Maximal range of motion of hip abduction and hip flexion (seat and reach test) and
      dorsal flexion will be measured at the beginning, after warm up, during each series of static
      stretching, after last series of static stretching, 7.5 minutes after last series of static
      stretching and 15 minutes after last series of static stretching.

      Maximal power [W/kg] and height [m] of the countermovement jump will be monitored with force
      plate at the beginning, after warm up, after each series of static stretching, 7.5 minutes
      after last series of static stretching and 15 minutes after last series of static stretching.

      On dynamometer will be conducted 2 maximal explosive voluntary contractions of adductors
      muscles. Relative maximal torque [Nm/kgBM] and rate of torque developement [Nm/s/kgBM] will
      be measured at the beginning, after warm up, after last series of static stretching, 7.5
      minutes after last series of static stretching and 15 minutes after last series of static
      stretching.

      In the second condition (experimental) all the tasks are the same, the only difference is
      that the subjects must conduct activation exercises after last series of static stretching.

      Activation exercises are consisted of 2 series of 4 exercises. The first series (slow series)
      starts with 8 lifts onto toes (dorsal flexion) with knees extended, than continues with 8
      deep squats and 8 hip thrust and then terminates with four 4-seconds lasting maximal
      voluntary contraction of adductors with knees extended and with soft ball between the ankles.
      The second series (explosive) commences with 8 maximal vertical jumps conducted just with
      ankles, and then continues with 8 maximal countermovement jumps and 8 explosive hip thrusts.
      It finishes with 8 maximal explosive and 2 seconds lasting voluntary contractions of hip
      adductors with knees extended and with soft ball between the ankles.

      The researchers hypothesize that muscular performance (maximal power and height of the
      countermovement jump, maximal torque and rate of torque developement of adductors muscles)
      will be impaired after 7 series of static stretching. Second hypothesis is that negative
      effects will not last longer than 15 minutes and the last hypothesis is that static
      stretching induced negative effects can be eliminated with sets of activation exercises.

      Statistical analysis will be performed in SPSS (SPSS Statistics 22, IBM, New York). T-test,
      1-way and 2-way repeated measures ANOVA will be used to confirm the differences between
      average values.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: 19 subjects will be devided into two groups. The first group will conduct the control condition on Saturday and the second group will conduct the experimental condition on Sunday. One week later, the subjects will undergo the second visit, each group of subjects performing the opposite condition.
primary purpose: Basic Science
masking: None (Open Label)
measure: Muscle Performance
time frame: 1 week
description: Maximal and explosive strength of adductors, maximal power during countermovement jump
measure: Maximal power during countermovement jump
time frame: 1 week
description: Relative maximal power during countermovement jump on force plate (W/kg)
measure: Jump Height
time frame: 1 week
description: Maximal height of countermovement jump on force plate (m)
measure: Relative maximal torque of adductors on dynamometer (Nm/kgBM)
time frame: 1 week
description: Maximal voluntary contraction of adductors will be performed on dynamometer.
measure: Rate of torque developement (Nm/s/kgBM)
time frame: 1 week
description: Rate of torque developement were monitored during Explosive maximal voluntary contraction of adductors performed on dynamometer.
measure: Maximal range of motion (cm)
time frame: 1 week
description: Maximal range of passive motion (bilaterally performed: seat&reach, hip abduction, dorsal foot flexion - for all, knees extended)
arm group label: Experimental condition
arm group type: Experimental
description: 7 series of static stretching will be conducted in the experimental condition. Activation exercises will be performed after 7th series of static stretching.
arm group label: Control
arm group type: Other
description: 7 series of static stretching will be conducted in the control condition.
intervention type: Other
intervention name: Activation exercise
description: Two series of 4 activation exercise will be included in the intervention.
arm group label: Experimental condition
intervention type: Other
intervention name: 7 series of static stretching
description: 7 series of 4 20 seconds static stretches will be conducted.
arm group label: Control
arm group label: Experimental condition
criteria: 
gender: Male
minimum age: 12 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nejc Sarabon, PhD
role: Study Director
affiliation: University of Primorska, Faculty of Health Studies, Izola, Slovenia
facility: 
country: Slovenia
responsible party type: Principal Investigator
investigator affiliation: University of Primorska
investigator full name: Nejc Sarabon
investigator title: Assoc. Prof. Dr. Sc.
sharing ipd: Undecided