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/NCT06032247</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00150439</org_study_id>
      <nct_id>NCT06032247</nct_id>
    </id_info>
    <brief_title>Bilateral Versus Unilateral Strength Training After ACLR</brief_title>
    <acronym>BUST</acronym>
    <official_title>Effect of Bilateral Versus Unilateral Lower Body Resistance Training on Musculoskeletal Outcomes in Individuals With a Previous Anterior Cruciate Ligament Reconstruction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Kansas</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Kansas</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>
        After rehabilitation completion, there remains large deficiencies between the operative (OP)&#xD;
        and non-operative (NOP) limbs in lower-limb outcomes (e.g., size, strength, and function) and&#xD;
        these deficits can persist for years. Therefore, further specialized training protocols, such&#xD;
        as the ones in the present study, are required to determine if these deficits can be&#xD;
        lessened. The proposed project will evaluate the effect of 8-weeks of single-leg and&#xD;
        double-leg lower-body resistance training on musculoskeletal function in individuals with a&#xD;
        previous anterior cruciate ligament (ACL) reconstruction (ACLR) in a randomized control&#xD;
        trial. The study will recruit 30-40 males and females between 18-35 years of age that have&#xD;
        undergone a previous ACLR. Participants will be randomized to either the&#xD;
        single-leg/unilateral (UL) or double-leg/bilateral (BL) training groups. Training will occur&#xD;
        three times per week for 8-weeks. The UL group will participate in exercises such as split&#xD;
        squats, single-leg deadlifts, or single-leg squats. The BL group will utilize exercises such&#xD;
        as double-leg squats, conventional deadlifts, and leg presses. One week prior to (PRE) and&#xD;
        one week after (POST) the training program, all participants will undergo a testing battery.&#xD;
        Musculoskeletal ultrasound will measure quadriceps and hamstrings muscle cross-sectional area&#xD;
        (mCSA), fascicle length (FL), and pennation angle (PA) of both OP and NOP limbs. Strength&#xD;
        will be assessed through maximal voluntary isometric contractions (MVIC) for the quadriceps&#xD;
        and hamstrings, and one-repetition maximum tests for single-leg leg extensions, leg curls,&#xD;
        and leg press. Lower-limb function will be assessed through single-leg and double-leg jumps&#xD;
        on a dual force plate system for jump height, impulse, rate of force development, and peak&#xD;
        force. Data will be analyzed via separate mixed-factorial analyses of variance for the&#xD;
        within-subjects factor of leg (OP vs. NOP) and time (PRE vs. POST) and the between-subjects&#xD;
        factor of biological sex (male vs. female) and group (UL vs. BL). Post-hoc analyses will&#xD;
        include lower-order ANOVAs and t-tests as pairwise comparisons when significance is detected.&#xD;
        Significance will be established at p≤0.05. The results of this study will assist&#xD;
        practitioners, coaches, sport scientists, and most importantly, the athletes, in the&#xD;
        development of post-rehabilitative strength training protocols designed to reduce&#xD;
        between-limb discrepancies.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 31, 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in isometric strength of the quadriceps femoris</measure>
      <time_frame>9-weeks</time_frame>
      <description>Change in maximal voluntary isometric contraction (MVIC) peak torque (Nm) of the quadriceps from PRE (baseline) to POST</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in muscle cross-sectional area of the quadriceps femoris</measure>
      <time_frame>9-weeks</time_frame>
      <description>Change in absolute muscle cross-sectional area (mCSA, cm^2) of the quadriceps femoris (vastus lateralis, rectus femoris, vastus medialis) from PRE (baseline) to POST</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in muscle cross-sectional area strength of the hamstrings</measure>
      <time_frame>9-weeks</time_frame>
      <description>Change in absolute muscle cross-sectional area (mCSA, cm^2) of the hamstrings (biceps femoris, semimembranous, semitendinosus) from PRE (baseline) to POST</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in isometric strength of the hamstrings femoris</measure>
      <time_frame>9-weeks</time_frame>
      <description>Change in maximal voluntary isometric contraction (MVIC) peak torque (Nm) of the hamstrings PRE (baseline) to POST</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in jump height of both limbs</measure>
      <time_frame>9-weeks</time_frame>
      <description>Change in jump height (cm) during countermovement jumps from PRE (baseline)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in jump impulse of both limbs</measure>
      <time_frame>9-weeks</time_frame>
      <description>Change in vertical jump impulse (N/kg/s) during countermovement jumps from PRE (baseline)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in body composition</measure>
      <time_frame>9-weeks</time_frame>
      <description>Change in body composition (body fat percentage (%)) assessed by bioelectrical impedance analysis (BIA) from PRE (baseline).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in segmental body composition</measure>
      <time_frame>9-weeks</time_frame>
      <description>Change in segmental (legs) fat-free mass (kg) as assessed by bioelectrical impedance analysis</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in dynamic strength of the quadriceps and hamstrings</measure>
      <time_frame>9-weeks</time_frame>
      <description>Change in dynamic strength (kg) of the knee extensors, knee flexors, and total thigh musculature assessed by one-repetition maximum (1-RM) testing for single-leg leg extension, single-leg leg curl, and double-leg press from PRE (baseline)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Anterior Cruciate Ligament Injuries</condition>
    <condition>Atrophy, Muscular</condition>
    <condition>Anterior Cruciate Ligament Rupture</condition>
    <condition>Anterior Cruciate Ligament Tear</condition>
    <arm_group>
      <arm_group_label>Unilateral strength training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Resistance training three times per week for 8-weeks on one leg at a time per exercise.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Bilateral strength training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Resistance training three times per week for 8-weeks on both legs at a time per exercise.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Resistance exercise program- UL</intervention_name>
      <description>Unilateral group:&#xD;
  Exercise sessions supervised by an exercise professional. Exercises will include single-leg squats, split squats, single-leg deadlifts, single-leg leg extensions, etc. Repetition range and volume (sets performed) will target strength and hypertrophy range with linear periodization utilized to ensure progression.</description>
      <arm_group_label>Unilateral strength training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Resistance exercise program- BL</intervention_name>
      <description>Bilateral group:&#xD;
  Exercise sessions supervised by an exercise professional. Exercises will include double-leg squats, double-leg deadlifts, double-leg leg extensions, etc. Repetition range and volume (sets performed) will target strength and hypertrophy range with linear periodization utilized to ensure progression.</description>
      <arm_group_label>Bilateral strength training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participant has provided written and dated informed consent to participate in the&#xD;
               study&#xD;
  &#xD;
            2. Participant is 18-35 years of age, inclusive&#xD;
  &#xD;
            3. Participant is in good health as determined by a health history questionnaire&#xD;
  &#xD;
            4. Participant has been medically cleared to return to sport after primary ACLR in the&#xD;
               previous two years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participant has a history of other lower-body related injuries in the past 6-months.&#xD;
  &#xD;
            2. Participant has undergone more than one ACLR or has injured the ACL of both legs.&#xD;
  &#xD;
            3. Participant has implants, hardware, devices, or other non-removable metal material in&#xD;
               the body that would limit the accuracy of skeletal muscle size and body composition&#xD;
               assessments within the measurement area.&#xD;
  &#xD;
            4. Participant has a cardiovascular, metabolic, or neuromuscular disorder that&#xD;
               contraindicates their ability to participate in an exercise program.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Christopher J Cleary, MS</last_name>
      <phone>781-670-6422</phone>
      <email>cj.cleary@ku.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ashley A Herda, PhD</last_name>
      <email>a.herda@ku.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Kansas Edwards Campus</name>
        <address>
          <city>Overland Park</city>
          <state>Kansas</state>
          <zip>66213</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Christopher J Cleary, MS</last_name>
        <phone>781-670-6422</phone>
        <email>cj.cleary@ku.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Kansas</investigator_affiliation>
      <investigator_full_name>Christopher Cleary, MS, CPSS, CSCS</investigator_full_name>
      <investigator_title>PhD Candidate</investigator_title>
    </responsible_party>
    <keyword>rehabilitation</keyword>
    <keyword>periodization</keyword>
    <keyword>injury risk reduction</keyword>
    <keyword>strength training</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Muscular Atrophy</mesh_term>
      <mesh_term>Rupture</mesh_term>
      <mesh_term>Anterior Cruciate Ligament Injuries</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/NCT06032247
  org study id: STUDY00150439
  nct id: NCT06032247
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  After rehabilitation completion, there remains large deficiencies between the operative (OP)
        and non-operative (NOP) limbs in lower-limb outcomes (e.g., size, strength, and function) and
        these deficits can persist for years. Therefore, further specialized training protocols, such
        as the ones in the present study, are required to determine if these deficits can be
        lessened. The proposed project will evaluate the effect of 8-weeks of single-leg and
        double-leg lower-body resistance training on musculoskeletal function in individuals with a
        previous anterior cruciate ligament (ACL) reconstruction (ACLR) in a randomized control
        trial. The study will recruit 30-40 males and females between 18-35 years of age that have
        undergone a previous ACLR. Participants will be randomized to either the
        single-leg/unilateral (UL) or double-leg/bilateral (BL) training groups. Training will occur
        three times per week for 8-weeks. The UL group will participate in exercises such as split
        squats, single-leg deadlifts, or single-leg squats. The BL group will utilize exercises such
        as double-leg squats, conventional deadlifts, and leg presses. One week prior to (PRE) and
        one week after (POST) the training program, all participants will undergo a testing battery.
        Musculoskeletal ultrasound will measure quadriceps and hamstrings muscle cross-sectional area
        (mCSA), fascicle length (FL), and pennation angle (PA) of both OP and NOP limbs. Strength
        will be assessed through maximal voluntary isometric contractions (MVIC) for the quadriceps
        and hamstrings, and one-repetition maximum tests for single-leg leg extensions, leg curls,
        and leg press. Lower-limb function will be assessed through single-leg and double-leg jumps
        on a dual force plate system for jump height, impulse, rate of force development, and peak
        force. Data will be analyzed via separate mixed-factorial analyses of variance for the
        within-subjects factor of leg (OP vs. NOP) and time (PRE vs. POST) and the between-subjects
        factor of biological sex (male vs. female) and group (UL vs. BL). Post-hoc analyses will
        include lower-order ANOVAs and t-tests as pairwise comparisons when significance is detected.
        Significance will be established at p≤0.05. The results of this study will assist
        practitioners, coaches, sport scientists, and most importantly, the athletes, in the
        development of post-rehabilitative strength training protocols designed to reduce
        between-limb discrepancies.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in isometric strength of the quadriceps femoris
  time frame: 9-weeks
  description: Change in maximal voluntary isometric contraction (MVIC) peak torque (Nm) of the quadriceps from PRE (baseline) to POST
  measure: Change in muscle cross-sectional area of the quadriceps femoris
  time frame: 9-weeks
  description: Change in absolute muscle cross-sectional area (mCSA, cm^2) of the quadriceps femoris (vastus lateralis, rectus femoris, vastus medialis) from PRE (baseline) to POST
  measure: Change in muscle cross-sectional area strength of the hamstrings
  time frame: 9-weeks
  description: Change in absolute muscle cross-sectional area (mCSA, cm^2) of the hamstrings (biceps femoris, semimembranous, semitendinosus) from PRE (baseline) to POST
  measure: Change in isometric strength of the hamstrings femoris
  time frame: 9-weeks
  description: Change in maximal voluntary isometric contraction (MVIC) peak torque (Nm) of the hamstrings PRE (baseline) to POST
  measure: Change in jump height of both limbs
  time frame: 9-weeks
  description: Change in jump height (cm) during countermovement jumps from PRE (baseline)
  measure: Change in jump impulse of both limbs
  time frame: 9-weeks
  description: Change in vertical jump impulse (N/kg/s) during countermovement jumps from PRE (baseline)
  measure: Change in body composition
  time frame: 9-weeks
  description: Change in body composition (body fat percentage (%)) assessed by bioelectrical impedance analysis (BIA) from PRE (baseline).
  measure: Change in segmental body composition
  time frame: 9-weeks
  description: Change in segmental (legs) fat-free mass (kg) as assessed by bioelectrical impedance analysis
  measure: Change in dynamic strength of the quadriceps and hamstrings
  time frame: 9-weeks
  description: Change in dynamic strength (kg) of the knee extensors, knee flexors, and total thigh musculature assessed by one-repetition maximum (1-RM) testing for single-leg leg extension, single-leg leg curl, and double-leg press from PRE (baseline)
  arm group label: Unilateral strength training
  arm group type: Experimental
  description: Resistance training three times per week for 8-weeks on one leg at a time per exercise.
  arm group label: Bilateral strength training
  arm group type: Active Comparator
  description: Resistance training three times per week for 8-weeks on both legs at a time per exercise.
  intervention type: Behavioral
  intervention name: Resistance exercise program- UL
  description: Unilateral group:
  Exercise sessions supervised by an exercise professional. Exercises will include single-leg squats, split squats, single-leg deadlifts, single-leg leg extensions, etc. Repetition range and volume (sets performed) will target strength and hypertrophy range with linear periodization utilized to ensure progression.
  arm group label: Unilateral strength training
  intervention type: Behavioral
  intervention name: Resistance exercise program- BL
  description: Bilateral group:
  Exercise sessions supervised by an exercise professional. Exercises will include double-leg squats, double-leg deadlifts, double-leg leg extensions, etc. Repetition range and volume (sets performed) will target strength and hypertrophy range with linear periodization utilized to ensure progression.
  arm group label: Bilateral strength training
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: No
  last name: Christopher J Cleary, MS
  phone: 781-670-6422
  email: cj.cleary@ku.edu
  last name: Ashley A Herda, PhD
  email: a.herda@ku.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Kansas
  investigator full name: Christopher Cleary, MS, CPSS, CSCS
  investigator title: PhD Candidate
  mesh term: Muscular Atrophy
  mesh term: Rupture
  mesh term: Anterior Cruciate Ligament Injuries
  sharing ipd: No