<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/NCT04458844</url>
  </required_header>
  <id_info>
    <org_study_id>SSSBLRECSTUD1449</org_study_id>
    <nct_id>NCT04458844</nct_id>
  </id_info>
  <brief_title>Strength and Fundamental Movement Skill (FMS) Training in Children</brief_title>
  <official_title>Integrated Strength and Fundamental Movement Skill (FMS) Training in Children: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teesside University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Teesside University</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>
      Competence in Fundamental movement skills (FMS) is essential to enable children to be&#xD;
      physical active. The aim of this study was to investigate the effects of integrated FMS skill&#xD;
      training (balancing and stabilisation skills, locomotor skills [e.g. run, hop, jump, crawl]&#xD;
      and object control / manipulation [e.g. dribbling, rolling, striking, kicking and catching&#xD;
      i.e. a ball] with strength training on FMS performance in children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">August 30, 2018</completion_date>
  <primary_completion_date type="Actual">July 22, 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>Factorial Assignment</intervention_model>
    <intervention_model_description>Cluster randomised control trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in product-process assessment of FMS via the Canadian agility and movement skills assessment (CAMSA)</measure>
    <time_frame>Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.</time_frame>
    <description>The Canadian agility and movement skills assessment (CAMSA), which combines product- and process-oriented outcomes was used to assess FMS. Full details of the CAMSA can be found in the Canadian Assessment of Physical Literacy Manual, 2017. Briefly, the CAMSA requires participants to travel a total distance of 20m while completing seven different movement skill tasks (Longmuir et al 2017) around an agility style course. Process oriented criteria were used to assess the performance of each movement skill. In addition, the throw and kick were scored as either hitting or missing a target 5m away (product assessment). Finally, the overall time taken to complete the course was recorded (product assessment) and converted into a timed score using pre-defined time criteria scores. The CAMSA raw score was calculated by adding the individual skill scores (max of 14 points) and the time criteria score (max of 14 points) giving an individual score between 1 and 28 points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in product assessment of FMS</measure>
    <time_frame>Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.</time_frame>
    <description>The investigators assessed locomotor performance through a countermovement jump and sprint assessments. Jump height was calculating from flight time measured by the Optojump Next (Microgate, Italy). Children were allowed up to three trial repetitions before completing three maximal jumps with the best performance used for analysis. Jumps were not counted if the children tucked their legs in the air or landing outside of the 1m square testing area. Sprint times were recorded over a distance of 40m to the nearest 0.01 second using an infrared timing gate system (Brower timing systems, Draper, USA). Sprints were repeated three times and the best score taken for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in strength</measure>
    <time_frame>Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.</time_frame>
    <description>Grip strength (Takei Grip-D) and counter movement jump (CMJ) (Optojump Next, Microgate, Italy) were recorded as measures of upper and lower body strength, respectively. The children followed a set of standardised instructions and completed three attempts on each test to give an average score for each test.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Fundamental Movement Skill Competence</condition>
  <arm_group>
    <arm_group_label>Fundamental Movement Skill (FMS) Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise 2 x per week focusing on Fundamental Movement Skill Development</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FMS and strength</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Replacement of 50% FMS training with integrated strength training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Intervention programmes were designed based on previous research (Duncan, et al., 2017; Faigenbaum, et al., 2011; Miller, et al., 2006) to ensure all exercises were developmentally appropriate for the age of the participants (an example session plan can be seen in the supplementary material). Each session consisted of five activities and lasted 50 - 60 minutes. Three out of the five activities were identical for the FMS and FMS+ groups, while two differed focusing on skill development for the FMS group and strength development for the FMS+ group. The FMS and FMS+ group received their sessions twice a week for 4 weeks. The sessions were delivered at least 48 hours apart to allow recovery and to reduce the risk of fatigue effecting performance (Faigenbaum, et al., 1996). All sessions were led by a researcher and a qualified sports coach.</description>
    <arm_group_label>FMS and strength</arm_group_label>
    <arm_group_label>Fundamental Movement Skill (FMS) Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 10 - 11 years in a participating primary school (cluster) for which the Head&#xD;
             Teacher has provided consent.&#xD;
&#xD;
          -  Parental consent received&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No parental consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Teesside University</name>
      <address>
        <city>Middlesbrough</city>
        <state>England</state>
        <zip>TS1 3BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Teesside University</investigator_affiliation>
    <investigator_full_name>Matthew Wright</investigator_full_name>
    <investigator_title>Lecturer in Biomechanics and Strength and Conditioning</investigator_title>
  </responsible_party>
  <!-- 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/NCT04458844
org study id: SSSBLRECSTUD1449
nct id: NCT04458844
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Competence in Fundamental movement skills (FMS) is essential to enable children to be
      physical active. The aim of this study was to investigate the effects of integrated FMS skill
      training (balancing and stabilisation skills, locomotor skills [e.g. run, hop, jump, crawl]
      and object control / manipulation [e.g. dribbling, rolling, striking, kicking and catching
      i.e. a ball] with strength training on FMS performance in children.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Cluster randomised control trial.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in product-process assessment of FMS via the Canadian agility and movement skills assessment (CAMSA)
time frame: Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.
description: The Canadian agility and movement skills assessment (CAMSA), which combines product- and process-oriented outcomes was used to assess FMS. Full details of the CAMSA can be found in the Canadian Assessment of Physical Literacy Manual, 2017. Briefly, the CAMSA requires participants to travel a total distance of 20m while completing seven different movement skill tasks (Longmuir et al 2017) around an agility style course. Process oriented criteria were used to assess the performance of each movement skill. In addition, the throw and kick were scored as either hitting or missing a target 5m away (product assessment). Finally, the overall time taken to complete the course was recorded (product assessment) and converted into a timed score using pre-defined time criteria scores. The CAMSA raw score was calculated by adding the individual skill scores (max of 14 points) and the time criteria score (max of 14 points) giving an individual score between 1 and 28 points.
measure: Change in product assessment of FMS
time frame: Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.
description: The investigators assessed locomotor performance through a countermovement jump and sprint assessments. Jump height was calculating from flight time measured by the Optojump Next (Microgate, Italy). Children were allowed up to three trial repetitions before completing three maximal jumps with the best performance used for analysis. Jumps were not counted if the children tucked their legs in the air or landing outside of the 1m square testing area. Sprint times were recorded over a distance of 40m to the nearest 0.01 second using an infrared timing gate system (Brower timing systems, Draper, USA). Sprints were repeated three times and the best score taken for analysis.
measure: Change in strength
time frame: Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.
description: Grip strength (Takei Grip-D) and counter movement jump (CMJ) (Optojump Next, Microgate, Italy) were recorded as measures of upper and lower body strength, respectively. The children followed a set of standardised instructions and completed three attempts on each test to give an average score for each test.
arm group label: Fundamental Movement Skill (FMS) Training
arm group type: Experimental
description: Exercise 2 x per week focusing on Fundamental Movement Skill Development
arm group label: FMS and strength
arm group type: Experimental
description: Replacement of 50% FMS training with integrated strength training.
arm group label: Control
arm group type: No Intervention
description: No intervention.
intervention type: Other
intervention name: Exercise
description: Intervention programmes were designed based on previous research (Duncan, et al., 2017; Faigenbaum, et al., 2011; Miller, et al., 2006) to ensure all exercises were developmentally appropriate for the age of the participants (an example session plan can be seen in the supplementary material). Each session consisted of five activities and lasted 50 - 60 minutes. Three out of the five activities were identical for the FMS and FMS+ groups, while two differed focusing on skill development for the FMS group and strength development for the FMS+ group. The FMS and FMS+ group received their sessions twice a week for 4 weeks. The sessions were delivered at least 48 hours apart to allow recovery and to reduce the risk of fatigue effecting performance (Faigenbaum, et al., 1996). All sessions were led by a researcher and a qualified sports coach.
arm group label: FMS and strength
arm group label: Fundamental Movement Skill (FMS) Training
criteria: 
gender: All
minimum age: 10 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Teesside University
investigator full name: Matthew Wright
investigator title: Lecturer in Biomechanics and Strength and Conditioning