xml: <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/NCT05973396</url>
    </required_header>
    <id_info>
      <org_study_id>PUIRB-2022-11</org_study_id>
      <nct_id>NCT05973396</nct_id>
    </id_info>
    <brief_title>The Effects of Mental and Physical Fatigue to Force Production in Adults</brief_title>
    <official_title>The Effects of Mental and Physical Fatigue to Force Production in Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Parker University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Parker 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>
        The primary objective is to investigate the correlation between physical and mental fatigue&#xD;
        to lower extremity force production in adults to determine if there is an association of&#xD;
        performance output that is inhibited by mental and physical stressors that mimic sport&#xD;
        environments that can be further investigated to determine the importance of not only&#xD;
        physical training and exercise for athletes, but also mental and cognitive exercises with&#xD;
        physical task to enhance performance training and rehabilitation of individuals.&#xD;
  &#xD;
        In adults, how does physical and mental fatigue in combination compared to those who are just&#xD;
        physically fatigued affect average peak height in performance of five CMJ with hands on hips.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In terms of injury prevention mental or cognitive fatigue and altered biomechanics play a&#xD;
        large role in risk of injury or reinjury. This can lead to disturbances in gait, balance or&#xD;
        even It is known that there are decreases in rate of force production in a physically&#xD;
        fatigued state.&#xD;
  &#xD;
        However, this does not show if a mentally fatigued and physically fatigued individual have&#xD;
        any negative implications towards a more dynamic and reactive test and conditions that mimic&#xD;
        sport more than static balancing or linear walking. It is even noted in reactive times of&#xD;
        post ACLr (one of the most common sports related injuries) have lower reactive times in&#xD;
        agility test With ACLr having a high level or rate or reinjury on surgical side and&#xD;
        nonsurgical side as well as known alterations of the cerebellum and specifically the primary&#xD;
        sensory cortex.Understanding how much a mental and physical fatigue can impact reactive&#xD;
        cognition and force production can be vital key in not only sports performance and&#xD;
        management, but also risk or injury and be associated in the plan of returning an athlete to&#xD;
        sport as power and force production is a key determinant of performance in many individual&#xD;
        and team sports. It is noted that physical activities directly enhance mental fatigue&#xD;
        significantly, but it is widely unresearched objectively how much or when physical fatigue&#xD;
        directly impacts mental cognition and decision making properties to an individual. In sport&#xD;
        it is crucial to act and react to be able to be successful. Multidirectional and team sports&#xD;
        involve constant mental cognition in terms of visual, auditory interpretation and cognition,&#xD;
        ability to recognize patterns and to finally physically perform tasks in a highly efficient&#xD;
        manner.&#xD;
  &#xD;
        The goal of an athlete is to be conditioned to play their best whether that is the first&#xD;
        minute of the game or its last. That means making the correct decision and physically&#xD;
        performing it. However, in a fatigued state can the athlete properly perform what is needed&#xD;
        to be done in a safe and effective manner that is comparable to a not fatigued state.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 18, 2022</start_date>
    <completion_date type="Actual">July 18, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</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>Other</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Average total height and force production of 5 Arms Fixed Countermovement jumps</measure>
      <time_frame>60 minutes</time_frame>
      <description>Average total height and force production of 5 Arms Fixed Countermovement jumps</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Difference in mental math pre and post experiment scores</measure>
      <time_frame>60 minutes</time_frame>
      <description>Difference in mental math pre and post experiment scores</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">16</enrollment>
    <condition>Mental Fatigue</condition>
    <condition>Muscle Weakness</condition>
    <arm_group>
      <arm_group_label>Control: Physical Fatigue only</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experiment: Mental and Physical Fatigue</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort with mentally fatiguing task during low intensity effort pace with stroop testing during 50 seconds</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical Fatiguing Task only</intervention_name>
      <description>Control group: 20-25 minutes [Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort] without mentally fatiguing task during low intensity effort pace</description>
      <arm_group_label>Control: Physical Fatigue only</arm_group_label>
      <other_name>Physical and Mental Fatiguing Task</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical and Mental Fatiguing Task</intervention_name>
      <description>Experimental group: 20-25 minutes [Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort] with mentally fatiguing task during low intensity effort pace (which includes: stroop test)</description>
      <arm_group_label>Experiment: Mental and Physical Fatigue</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Current students at Parker University from the ages of 21 to 65 years for safety concerns&#xD;
          Children were not considered for this study Elderly were not considered for this study&#xD;
          Current students who are currently physically active at least once a week&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Anyone with who self reports previous history of cardiovascular issues or&#xD;
               hospitalizations Rationale: Participants will be doing aerobic/ anaerobic efforts that&#xD;
               will increase their heart rate Source: Redcap Questionnaire, Baseline visit&#xD;
  &#xD;
            2. Lower extremity surgery within the last two years Rationale: Puts participant more at&#xD;
               risk of injury since inducing fatigue and a maximal power effort Source: Redcap&#xD;
               Questionnaire, Baseline visit&#xD;
  &#xD;
            3. Medical restrictions for full activity Rationale: Puts participant more at risk of&#xD;
               injury since inducing fatigue and a maximal power effort Source: Redcap Questionnaire,&#xD;
               Baseline visit&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Katherine Pohlman, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Director of Research</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>ParkerFit</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75220</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Parker University</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75229</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://doi.org/10.4085/1062-6050-266-18</url>
      <description>Related Info</description>
    </link>
    <link>
      <url>https://doi.org/10.1016/j.jsams.2018.07.004</url>
      <description>Related Info</description>
    </link>
    <link>
      <url>https://doi.org/10.3389/fneur.2018.00915</url>
      <description>Related Info</description>
    </link>
    <link>
      <url>https://doi.org/10.3390/ijerph182312364</url>
      <description>Related Info</description>
    </link>
    <link>
      <url>https://doi.org/10.1007/s40279-013-0090-5</url>
      <description>Related Info</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>November 8, 2022</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Force Production</keyword>
    <keyword>Muscular Fatigue</keyword>
    <keyword>Mental Cognition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Muscle Weakness</mesh_term>
      <mesh_term>Fatigue</mesh_term>
      <mesh_term>Mental Fatigue</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973396
  org study id: PUIRB-2022-11
  nct id: NCT05973396
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective is to investigate the correlation between physical and mental fatigue
        to lower extremity force production in adults to determine if there is an association of
        performance output that is inhibited by mental and physical stressors that mimic sport
        environments that can be further investigated to determine the importance of not only
        physical training and exercise for athletes, but also mental and cognitive exercises with
        physical task to enhance performance training and rehabilitation of individuals.
  
        In adults, how does physical and mental fatigue in combination compared to those who are just
        physically fatigued affect average peak height in performance of five CMJ with hands on hips.
  In terms of injury prevention mental or cognitive fatigue and altered biomechanics play a
        large role in risk of injury or reinjury. This can lead to disturbances in gait, balance or
        even It is known that there are decreases in rate of force production in a physically
        fatigued state.
  
        However, this does not show if a mentally fatigued and physically fatigued individual have
        any negative implications towards a more dynamic and reactive test and conditions that mimic
        sport more than static balancing or linear walking. It is even noted in reactive times of
        post ACLr (one of the most common sports related injuries) have lower reactive times in
        agility test With ACLr having a high level or rate or reinjury on surgical side and
        nonsurgical side as well as known alterations of the cerebellum and specifically the primary
        sensory cortex.Understanding how much a mental and physical fatigue can impact reactive
        cognition and force production can be vital key in not only sports performance and
        management, but also risk or injury and be associated in the plan of returning an athlete to
        sport as power and force production is a key determinant of performance in many individual
        and team sports. It is noted that physical activities directly enhance mental fatigue
        significantly, but it is widely unresearched objectively how much or when physical fatigue
        directly impacts mental cognition and decision making properties to an individual. In sport
        it is crucial to act and react to be able to be successful. Multidirectional and team sports
        involve constant mental cognition in terms of visual, auditory interpretation and cognition,
        ability to recognize patterns and to finally physically perform tasks in a highly efficient
        manner.
  
        The goal of an athlete is to be conditioned to play their best whether that is the first
        minute of the game or its last. That means making the correct decision and physically
        performing it. However, in a fatigued state can the athlete properly perform what is needed
        to be done in a safe and effective manner that is comparable to a not fatigued state.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Outcomes Assessor)
  measure: Average total height and force production of 5 Arms Fixed Countermovement jumps
  time frame: 60 minutes
  description: Average total height and force production of 5 Arms Fixed Countermovement jumps
  measure: Difference in mental math pre and post experiment scores
  time frame: 60 minutes
  description: Difference in mental math pre and post experiment scores
  arm group label: Control: Physical Fatigue only
  arm group type: Active Comparator
  description: Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort
  arm group label: Experiment: Mental and Physical Fatigue
  arm group type: Experimental
  description: Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort with mentally fatiguing task during low intensity effort pace with stroop testing during 50 seconds
  intervention type: Other
  intervention name: Physical Fatiguing Task only
  description: Control group: 20-25 minutes [Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort] without mentally fatiguing task during low intensity effort pace
  arm group label: Control: Physical Fatigue only
  other name: Physical and Mental Fatiguing Task
  intervention type: Other
  intervention name: Physical and Mental Fatiguing Task
  description: Experimental group: 20-25 minutes [Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort] with mentally fatiguing task during low intensity effort pace (which includes: stroop test)
  arm group label: Experiment: Mental and Physical Fatigue
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Katherine Pohlman, PhD
  role: Study Director
  affiliation: Director of Research
  facility: 
  facility: 
  country: United States
  url: https://doi.org/10.4085/1062-6050-266-18
  description: Related Info
  url: https://doi.org/10.1016/j.jsams.2018.07.004
  description: Related Info
  url: https://doi.org/10.3389/fneur.2018.00915
  description: Related Info
  url: https://doi.org/10.3390/ijerph182312364
  description: Related Info
  url: https://doi.org/10.1007/s40279-013-0090-5
  description: Related Info
  responsible party type: Sponsor
  mesh term: Muscle Weakness
  mesh term: Fatigue
  mesh term: Mental Fatigue
  sharing ipd: No