<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/NCT03035266</url>
  </required_header>
  <id_info>
    <org_study_id>16KACH016</org_study_id>
    <nct_id>NCT03035266</nct_id>
  </id_info>
  <brief_title>The Effect of Blood Flow Restriction Training on Muscle Atrophy Following Knee Surgery</brief_title>
  <official_title>The Effect of Blood Flow Restriction Training on Muscle Atrophy Following Knee Surgery; A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Keller Army Community Hospital</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Keller Army Community Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will compare differences in quadriceps strength, leg girth, and functional&#xD;
      outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months&#xD;
      following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight&#xD;
      bearing or limited weight bearing status in a brace at 0° degrees of knee extension. One&#xD;
      group will receive BFR with standard post-operative rehabilitation for 12 weeks followed by&#xD;
      the standard protocol progression for the remainder of the treatment program. The other group&#xD;
      will receive standard post-operative rehabilitation without BFR for the duration of treatment&#xD;
      program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim is to compare strength, patient reported outcomes, and functional outcomes of&#xD;
      post-operative therapy with and without adjunctive BFR training. To accomplish this task the&#xD;
      investigators will compare differences in thigh girth between two groups of patients after&#xD;
      the first 6 weeks and 12 weeks as well as 6 months following meniscus or articular cartilage&#xD;
      repair requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at&#xD;
      0˚ degrees of extension. In addition, isokinetic testing of the quadriceps and hamstrings&#xD;
      will be performed at 12 weeks and 6 months post-operatively. Lower extremity girth&#xD;
      measurements after knee surgery can be performed with good to excellent intra- and&#xD;
      inter-rater reliability. Quadriceps strength measured with isokinetic testing is related to&#xD;
      performance measures such as jumping. Limb circumference measurement, limb CSA measurement,&#xD;
      and isokinetic strength testing are commonly utilized in BFR studies as outcome measures.One&#xD;
      group will receive BFR for 12 weeks in addition to standard post-operative rehabilitation and&#xD;
      the other group will receive standard post-operative rehabilitation without BFR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 5, 2017</start_date>
  <completion_date type="Actual">March 12, 2020</completion_date>
  <primary_completion_date type="Actual">March 12, 2020</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>
    <intervention_model_description>This is a prospective, randomized control trial. After consenting, subjects will be randomized to one of two groups by using a computer generated random number.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigators recording thigh girth and isokinetic data will be blinded to group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Torque (foot-pounds), best repetition out of 15 repetitions</measure>
    <time_frame>12 weeks and 6 months post operative</time_frame>
    <description>Change in isokinetic peak torque knee extension and knee flexion at 180 degrees/sec and at 300 degrees/second</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thigh circumference (centimeters)</measure>
    <time_frame>baseline, 6 weeks, 12 weeks, and 6 months</time_frame>
    <description>Change in girth measurements of thigh:&#xD;
10 cm from proximal patella 15 cm from proximal patella 33% length from proximal patella to inguinal crease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS), 0 to 40 mm self report pain scale</measure>
    <time_frame>baseline, 6 weeks, 12 weeks, and 6 months</time_frame>
    <description>Change in VAS for Pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower Extremity Functional Scale (LEFS) Questionnaire</measure>
    <time_frame>baseline, 6 weeks, 12 weeks, and 6 months</time_frame>
    <description>Change in LEFS Outcome Measure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Knee Injuries</condition>
  <arm_group>
    <arm_group_label>Blood Flow Restriction (BFR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will perform traditional post-operative rehabilitation until discharge from the hospital following surgery and continue until formal discharge from physical therapy upon completion of rehabilitation. One week following surgery, subjects randomized to the BFR group will begin combining BFR with all lower extremity strengthening exercises supervised in clinic up to 3 times per week for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard rehabilitation (control group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All subjects will perform traditional post-operative rehabilitation until discharge from the hospital following surgery and continue until formal discharge from physical therapy upon completion of rehabilitation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood Flow Restriction</intervention_name>
    <description>Delfi's Personalized Tourniquet System for Blood Flow Restriction has been specifically designed to safely regulate and control tourniquet pressure. Occlusion pressures will be set at 80% of total occlusive pressure as determined by the Doppler sensor. Each subject will perform 4 sets of each exercise (1 set of 30 repetitions followed by 3 sets of 15 repetitions). The pressure will remain through completion of the final set, but not to exceed 5 minutes. One minute rest without tourniquet application will be performed between 5 minute cycles. Sets and repetitions will remain constant for each subject; however, resistance will be incrementally increased after the subject is able to complete all 75 repetitions without loss of proper form.</description>
    <arm_group_label>Blood Flow Restriction (BFR)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard rehabilitation</intervention_name>
    <description>Standard of care for post-operative condition</description>
    <arm_group_label>Standard rehabilitation (control group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Military healthcare beneficiaries between the age of 18 and 50 years.&#xD;
&#xD;
          -  Must intend to remain on station at location of surgery for 6 months from date of&#xD;
             surgery.&#xD;
&#xD;
          -  Meniscus repair or cartilage restoration technique to include microfracture,&#xD;
             osteochondral autograft transfer system, osteochondral allograft transplantation, and&#xD;
             autologous chondrocyte implantation following standard post-operative protocol&#xD;
             guidelines requiring a 6 week period of non-weight bearing or limited weight bearing&#xD;
             in a brace at 0˚ degrees of extension.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant ligamentous repair/reconstruction&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Any medical condition for which aerobic exercise is contraindicated&#xD;
&#xD;
          -  Additional back, hip, or knee surgery in the previous 12 months&#xD;
&#xD;
          -  History of vascular or cardiac impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John S Mason, DSc, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Keller Army Community Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keller Army Community Hospital</name>
      <address>
        <city>West Point</city>
        <state>New York</state>
        <zip>10996</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Womack Army Medical Center</name>
      <address>
        <city>Fort Bragg</city>
        <state>North Carolina</state>
        <zip>28310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>August 19, 2020</last_update_submitted>
  <last_update_submitted_qc>August 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Keller Army Community Hospital</investigator_affiliation>
    <investigator_full_name>John Mason</investigator_full_name>
    <investigator_title>Assistant Chief, PT</investigator_title>
  </responsible_party>
  <keyword>blood flow restriction</keyword>
  <keyword>strength</keyword>
  <keyword>muscle atrophy</keyword>
  <keyword>post-operative therapy</keyword>
  <keyword>knee</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Atrophy</mesh_term>
    <mesh_term>Knee 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>


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/NCT03035266
org study id: 16KACH016
nct id: NCT03035266
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The investigators will compare differences in quadriceps strength, leg girth, and functional
      outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months
      following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight
      bearing or limited weight bearing status in a brace at 0° degrees of knee extension. One
      group will receive BFR with standard post-operative rehabilitation for 12 weeks followed by
      the standard protocol progression for the remainder of the treatment program. The other group
      will receive standard post-operative rehabilitation without BFR for the duration of treatment
      program.
The aim is to compare strength, patient reported outcomes, and functional outcomes of
      post-operative therapy with and without adjunctive BFR training. To accomplish this task the
      investigators will compare differences in thigh girth between two groups of patients after
      the first 6 weeks and 12 weeks as well as 6 months following meniscus or articular cartilage
      repair requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at
      0˚ degrees of extension. In addition, isokinetic testing of the quadriceps and hamstrings
      will be performed at 12 weeks and 6 months post-operatively. Lower extremity girth
      measurements after knee surgery can be performed with good to excellent intra- and
      inter-rater reliability. Quadriceps strength measured with isokinetic testing is related to
      performance measures such as jumping. Limb circumference measurement, limb CSA measurement,
      and isokinetic strength testing are commonly utilized in BFR studies as outcome measures.One
      group will receive BFR for 12 weeks in addition to standard post-operative rehabilitation and
      the other group will receive standard post-operative rehabilitation without BFR.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a prospective, randomized control trial. After consenting, subjects will be randomized to one of two groups by using a computer generated random number.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Investigators recording thigh girth and isokinetic data will be blinded to group assignment.
measure: Peak Torque (foot-pounds), best repetition out of 15 repetitions
time frame: 12 weeks and 6 months post operative
description: Change in isokinetic peak torque knee extension and knee flexion at 180 degrees/sec and at 300 degrees/second
measure: Thigh circumference (centimeters)
time frame: baseline, 6 weeks, 12 weeks, and 6 months
description: Change in girth measurements of thigh:
10 cm from proximal patella 15 cm from proximal patella 33% length from proximal patella to inguinal crease
measure: Visual Analog Scale (VAS), 0 to 40 mm self report pain scale
time frame: baseline, 6 weeks, 12 weeks, and 6 months
description: Change in VAS for Pain
measure: Lower Extremity Functional Scale (LEFS) Questionnaire
time frame: baseline, 6 weeks, 12 weeks, and 6 months
description: Change in LEFS Outcome Measure
arm group label: Blood Flow Restriction (BFR)
arm group type: Experimental
description: All subjects will perform traditional post-operative rehabilitation until discharge from the hospital following surgery and continue until formal discharge from physical therapy upon completion of rehabilitation. One week following surgery, subjects randomized to the BFR group will begin combining BFR with all lower extremity strengthening exercises supervised in clinic up to 3 times per week for 12 weeks.
arm group label: Standard rehabilitation (control group)
arm group type: Active Comparator
description: All subjects will perform traditional post-operative rehabilitation until discharge from the hospital following surgery and continue until formal discharge from physical therapy upon completion of rehabilitation.
intervention type: Other
intervention name: Blood Flow Restriction
description: Delfi's Personalized Tourniquet System for Blood Flow Restriction has been specifically designed to safely regulate and control tourniquet pressure. Occlusion pressures will be set at 80% of total occlusive pressure as determined by the Doppler sensor. Each subject will perform 4 sets of each exercise (1 set of 30 repetitions followed by 3 sets of 15 repetitions). The pressure will remain through completion of the final set, but not to exceed 5 minutes. One minute rest without tourniquet application will be performed between 5 minute cycles. Sets and repetitions will remain constant for each subject; however, resistance will be incrementally increased after the subject is able to complete all 75 repetitions without loss of proper form.
arm group label: Blood Flow Restriction (BFR)
intervention type: Other
intervention name: Standard rehabilitation
description: Standard of care for post-operative condition
arm group label: Standard rehabilitation (control group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: John S Mason, DSc, DPT
role: Principal Investigator
affiliation: Keller Army Community Hospital
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Keller Army Community Hospital
investigator full name: John Mason
investigator title: Assistant Chief, PT
mesh term: Muscular Atrophy
mesh term: Atrophy
mesh term: Knee Injuries
sharing ipd: No