<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/NCT04480528</url>
  </required_header>
  <id_info>
    <org_study_id>54348</org_study_id>
    <nct_id>NCT04480528</nct_id>
  </id_info>
  <brief_title>Strength Training in Female Runners With Patellofemoral Pain</brief_title>
  <official_title>The Effect of Various Strength Training Protocols in Female Runners With Patellofemoral Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lauren Erickson</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American College of Sports Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kentucky</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>
      Patellofemoral pain (PFP) is a common running-related injury that is often referred to as&#xD;
      runner's knee. The condition typically presents with pain in the front of the knee that is&#xD;
      located around or behind the knee cap. This injury occurs twice as frequently in females and&#xD;
      is often associated with weakness of the muscles of the thigh and hip, as well as altered&#xD;
      running form. Heavy-weight strength training is needed in order to improve muscle weakness;&#xD;
      however, this puts a significant amount of load on the knee joint and it is difficult for&#xD;
      individuals with PFP to train at this level without experiencing increased pain and joint&#xD;
      discomfort. Blood flow restriction training (BFRT) is a promising alternative method to&#xD;
      safely improve muscle weakness while reducing knee joint loading. With BFRT, a pressurized&#xD;
      band is applied to the thigh in order to partially restrict blood flow as a patient exercises&#xD;
      in order to decrease the amount of oxygen delivered to the muscle. Lack of oxygen to the&#xD;
      muscle combined with strength training creates an environment within the muscle that results&#xD;
      in the ability of low-weight strength training to provide the same results as heavy-weight&#xD;
      strength training.&#xD;
&#xD;
      This study will evaluate how low-weight strength training with and without BFRT affects thigh&#xD;
      and hip strength, and consequently pain, function, running ability, and running form in&#xD;
      female runners with PFP. The hypothesis is that 10 weeks of low-weight strength training with&#xD;
      BFRT will lead to greater thigh and hip strength, reduced pain, improved knee function,&#xD;
      improved running ability, and improved running form compared to low-weight strength training&#xD;
      without BFRT. The expected results will have a significant impact within the running&#xD;
      community by providing a safe and effective treatment that increases strength and improves&#xD;
      running form while reducing pain and joint loading. This will also have an impact on the&#xD;
      larger field of sports medicine by providing an alternative method to improve strength, as&#xD;
      well as improve function when heavy-weight strength training is not well tolerated or unsafe&#xD;
      due to injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Actual">November 13, 2021</completion_date>
  <primary_completion_date type="Actual">November 13, 2021</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Isometric Quadriceps Strength</measure>
    <time_frame>10 weeks</time_frame>
    <description>The subject will be seated in a Biodex 4 dynamometer with their knee locked at 90 degrees of flexion. The subject will be asked to kick into the dynamometer pad as hard as they can and the peak force will be measured and normalized to body weight. Increased force indicates greater quadriceps strength.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Isokinetic Quadriceps Strength</measure>
    <time_frame>10 weeks</time_frame>
    <description>The subject will be seated in a Biodex 4 dynamometer and be asked to kick back-and-forth into the dynamometer pad as hard and as fast as they can. The peak force will be measured and normalized to body weight. Increased force indicates greater quadriceps strength.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Isometric Hip Abduction Strength</measure>
    <time_frame>10 weeks</time_frame>
    <description>The subject will be lying in the side-lying position with a stabilizing strap placed around the thigh. The subject will be asked to press out as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip abduction strength.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Isometric Hip Extension Strength</measure>
    <time_frame>10 weeks</time_frame>
    <description>The subject will be lying on their stomach with their knee flexed to 90 degrees and a stabilizing strap placed around the thigh. The subject will be asked to press up as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip extension strength.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Isometric Hip External Rotation Strength</measure>
    <time_frame>10 weeks</time_frame>
    <description>The subject will be seated with their knee flexed to 90 degrees and a stabilizing strap placed around the lower leg. The subject will be asked to press inward as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip external rotation strength.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Hip Adduction Angle</measure>
    <time_frame>10 weeks</time_frame>
    <description>Change in peak hip adduction angle will be measured via a three-dimensional running gait analysis on an instrumented treadmill.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hip Internal Rotation Angle</measure>
    <time_frame>10 weeks</time_frame>
    <description>Change in peak hip internal rotation angle will be measured via a three-dimensional running gait analysis on an instrumented treadmill.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Peak Knee Extensor Moment</measure>
    <time_frame>10 weeks</time_frame>
    <description>Change in peak knee extensor moment will be measured via a three-dimensional running gait analysis on an instrumented treadmill.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain: Brief Pain Inventory (BPI)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Pain will be measured using the Brief Pain Inventory (BPI), which assesses pain (least, most, average, and present pain) on a scale from 0-10. Lower numbers indicate less pain while higher numbers indicate more pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patellofemoral Pain: Knee Injury and Osteoarthritis Outcome Score</measure>
    <time_frame>10 weeks</time_frame>
    <description>Patellofemoral pain will be measured using the Knee Injury and Osteoarthritis Outcome Score - Patellofemoral Pain. It is an 11-item questionnaire and items are coded from 0 to 4, no problems to extreme problems. Scores are transformed to a 0-100 scale and represent the percentage of total possible score achieved. Lower numbers indicate greater knee patellofemoral pain while higher numbers indicate less patellofemoral pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Function</measure>
    <time_frame>10 weeks</time_frame>
    <description>Knee function will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) which contains 5 subscales: Pain - 9 items, other Symptoms - 7 items, Function in daily living (ADL) - 17 items, Function in Sport and Recreation (Sport/Rec) - 5 items, and knee-related Quality of Life (QoL) - 4 items. Items are coded from 0 to 4, no problems to extreme problems. Scores are transformed to a 0-100 scale and represent the percentage of total possible score achieved. Lower numbers indicate greater knee problems while higher numbers indicate less knee problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Running Ability</measure>
    <time_frame>10 weeks</time_frame>
    <description>Running ability will be measured using the University of Wisconsin Running Injury and Recovery Index (UWRI). It is a 9-item questionnaire and items are coded from 0 to 4, lower scores indicating an inability to run and higher scores indicating no pain/issue with running. Scores are transformed to a 0-100 scale and represent the percentage of total possible score achieved. Lower numbers indicate limited running ability while higher numbers indicate full running ability.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Patellofemoral Syndrome</condition>
  <arm_group>
    <arm_group_label>BFRT Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive physical therapy plus active BFRT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>This group will receive physical therapy plus sham BFRT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood Flow Restriction Training (BFRT)</intervention_name>
    <description>A pressurized cuff is applied to the proximal thigh in order to partially occlude blood flow as the patient exercises.</description>
    <arm_group_label>BFRT Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Blood Flow Restriction Training (Sham BFRT)</intervention_name>
    <description>A minimally pressurized cuff is applied to the proximal thigh in order to mimic the active blood flow restriction unit as the patient exercises.</description>
    <arm_group_label>Standard of Care Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pain around (peripatellar) or behind (retropatellar) the patella, which is aggravated&#xD;
             by running and at least one other activity that loads the patellofemoral joint during&#xD;
             weight bearing on a flexed knee such as kneeling, squatting, stair ambulation, and&#xD;
             jumping/hopping&#xD;
&#xD;
          -  Insidious onset of symptoms unrelated to trauma&#xD;
&#xD;
          -  Pain present for at least 2 months&#xD;
&#xD;
          -  Pain rating of at least 3/10 on the visual analog scale during running&#xD;
&#xD;
          -  Report running at least 10 miles per week currently or just prior to onset of injury&#xD;
&#xD;
          -  Score a maximum of 85% on either the Knee Outcome Survey Activities of Daily Living&#xD;
             Scale or Sports Activity Scale (KOS-ADL or KOS-SAS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Knee pain resulting from acute trauma&#xD;
&#xD;
          -  Concurrent ligamentous instability, meniscus pathology, patellar or iliotibial band&#xD;
             tendinopathy&#xD;
&#xD;
          -  History of patellar dislocations or instability, or previous reconstructive surgery to&#xD;
             the knee&#xD;
&#xD;
          -  Other lower extremity or lower back injury within the past 6 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lauren Erickson, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>March 3, 2022</last_update_submitted>
  <last_update_submitted_qc>March 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Lauren Erickson</investigator_full_name>
    <investigator_title>Graduate Research Assistant</investigator_title>
  </responsible_party>
  <keyword>Blood Flow Restriction</keyword>
  <keyword>Running</keyword>
  <keyword>Patellofemoral Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04480528
org study id: 54348
nct id: NCT04480528
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patellofemoral pain (PFP) is a common running-related injury that is often referred to as
      runner's knee. The condition typically presents with pain in the front of the knee that is
      located around or behind the knee cap. This injury occurs twice as frequently in females and
      is often associated with weakness of the muscles of the thigh and hip, as well as altered
      running form. Heavy-weight strength training is needed in order to improve muscle weakness;
      however, this puts a significant amount of load on the knee joint and it is difficult for
      individuals with PFP to train at this level without experiencing increased pain and joint
      discomfort. Blood flow restriction training (BFRT) is a promising alternative method to
      safely improve muscle weakness while reducing knee joint loading. With BFRT, a pressurized
      band is applied to the thigh in order to partially restrict blood flow as a patient exercises
      in order to decrease the amount of oxygen delivered to the muscle. Lack of oxygen to the
      muscle combined with strength training creates an environment within the muscle that results
      in the ability of low-weight strength training to provide the same results as heavy-weight
      strength training.

      This study will evaluate how low-weight strength training with and without BFRT affects thigh
      and hip strength, and consequently pain, function, running ability, and running form in
      female runners with PFP. The hypothesis is that 10 weeks of low-weight strength training with
      BFRT will lead to greater thigh and hip strength, reduced pain, improved knee function,
      improved running ability, and improved running form compared to low-weight strength training
      without BFRT. The expected results will have a significant impact within the running
      community by providing a safe and effective treatment that increases strength and improves
      running form while reducing pain and joint loading. This will also have an impact on the
      larger field of sports medicine by providing an alternative method to improve strength, as
      well as improve function when heavy-weight strength training is not well tolerated or unsafe
      due to injury.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Isometric Quadriceps Strength
time frame: 10 weeks
description: The subject will be seated in a Biodex 4 dynamometer with their knee locked at 90 degrees of flexion. The subject will be asked to kick into the dynamometer pad as hard as they can and the peak force will be measured and normalized to body weight. Increased force indicates greater quadriceps strength.
measure: Change in Isokinetic Quadriceps Strength
time frame: 10 weeks
description: The subject will be seated in a Biodex 4 dynamometer and be asked to kick back-and-forth into the dynamometer pad as hard and as fast as they can. The peak force will be measured and normalized to body weight. Increased force indicates greater quadriceps strength.
measure: Change in Isometric Hip Abduction Strength
time frame: 10 weeks
description: The subject will be lying in the side-lying position with a stabilizing strap placed around the thigh. The subject will be asked to press out as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip abduction strength.
measure: Change in Isometric Hip Extension Strength
time frame: 10 weeks
description: The subject will be lying on their stomach with their knee flexed to 90 degrees and a stabilizing strap placed around the thigh. The subject will be asked to press up as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip extension strength.
measure: Change in Isometric Hip External Rotation Strength
time frame: 10 weeks
description: The subject will be seated with their knee flexed to 90 degrees and a stabilizing strap placed around the lower leg. The subject will be asked to press inward as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip external rotation strength.
measure: Change in Hip Adduction Angle
time frame: 10 weeks
description: Change in peak hip adduction angle will be measured via a three-dimensional running gait analysis on an instrumented treadmill.
measure: Change in Hip Internal Rotation Angle
time frame: 10 weeks
description: Change in peak hip internal rotation angle will be measured via a three-dimensional running gait analysis on an instrumented treadmill.
measure: Change in Peak Knee Extensor Moment
time frame: 10 weeks
description: Change in peak knee extensor moment will be measured via a three-dimensional running gait analysis on an instrumented treadmill.
measure: Change in Pain: Brief Pain Inventory (BPI)
time frame: 10 weeks
description: Pain will be measured using the Brief Pain Inventory (BPI), which assesses pain (least, most, average, and present pain) on a scale from 0-10. Lower numbers indicate less pain while higher numbers indicate more pain.
measure: Change in Patellofemoral Pain: Knee Injury and Osteoarthritis Outcome Score
time frame: 10 weeks
description: Patellofemoral pain will be measured using the Knee Injury and Osteoarthritis Outcome Score - Patellofemoral Pain. It is an 11-item questionnaire and items are coded from 0 to 4, no problems to extreme problems. Scores are transformed to a 0-100 scale and represent the percentage of total possible score achieved. Lower numbers indicate greater knee patellofemoral pain while higher numbers indicate less patellofemoral pain.
measure: Change in Knee Function
time frame: 10 weeks
description: Knee function will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) which contains 5 subscales: Pain - 9 items, other Symptoms - 7 items, Function in daily living (ADL) - 17 items, Function in Sport and Recreation (Sport/Rec) - 5 items, and knee-related Quality of Life (QoL) - 4 items. Items are coded from 0 to 4, no problems to extreme problems. Scores are transformed to a 0-100 scale and represent the percentage of total possible score achieved. Lower numbers indicate greater knee problems while higher numbers indicate less knee problems.
measure: Change in Running Ability
time frame: 10 weeks
description: Running ability will be measured using the University of Wisconsin Running Injury and Recovery Index (UWRI). It is a 9-item questionnaire and items are coded from 0 to 4, lower scores indicating an inability to run and higher scores indicating no pain/issue with running. Scores are transformed to a 0-100 scale and represent the percentage of total possible score achieved. Lower numbers indicate limited running ability while higher numbers indicate full running ability.
arm group label: BFRT Group
arm group type: Experimental
description: This group will receive physical therapy plus active BFRT.
arm group label: Standard of Care Group
arm group type: Sham Comparator
description: This group will receive physical therapy plus sham BFRT.
intervention type: Other
intervention name: Blood Flow Restriction Training (BFRT)
description: A pressurized cuff is applied to the proximal thigh in order to partially occlude blood flow as the patient exercises.
arm group label: BFRT Group
intervention type: Other
intervention name: Sham Blood Flow Restriction Training (Sham BFRT)
description: A minimally pressurized cuff is applied to the proximal thigh in order to mimic the active blood flow restriction unit as the patient exercises.
arm group label: Standard of Care Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Lauren Erickson, DPT
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Lauren Erickson
investigator title: Graduate Research Assistant
mesh term: Patellofemoral Pain Syndrome
sharing ipd: No