<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/NCT01674101</url>
  </required_header>
  <id_info>
    <org_study_id>PTSARC</org_study_id>
    <secondary_id>TPTA (YR 1)</secondary_id>
    <secondary_id>NCI-2012-01920</secondary_id>
    <nct_id>NCT01674101</nct_id>
  </id_info>
  <brief_title>Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy</brief_title>
  <official_title>A Pilot Study on the Effects of Preoperative Physical Therapy in Adolescents and Young Adults Diagnosed With a Lower Extremity Malignancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tennessee Physical Therapy Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Jude Children's Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This application proposes a prospective clinical trial to evaluate the impact of adding a&#xD;
      focused physical therapy (PT) intervention to the preoperative regimen of individuals&#xD;
      diagnosed with a malignancy of the lower extremity (LE). The primary aim will be to determine&#xD;
      if individuals diagnosed with a malignancy of the LE can participate in a 10 week&#xD;
      preoperative strengthening, stretching, and aerobic exercise regimen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention group will receive PT 3 times per week for 60 minutes each session. The&#xD;
      therapy sessions will include endurance, strengthening, and stretching exercises. Endurance&#xD;
      exercises will consist of ambulating with assistive devices as needed, using the upper&#xD;
      extremity (UE) ergometer, and/or playing the Wii. Strengthening exercises will involve both&#xD;
      UE's and LE's. For UE's, bicep curls, triceps curls, shoulder flexion, and/or press-ups from&#xD;
      the therapy mat or wheelchair will be included. For the LE's, bridging, long arc quads,&#xD;
      hamstring curls, calf raises in standing, single LE squats, and/or dorsiflexion (DF) in&#xD;
      supine will be performed on the uninvolved extremity. Resistance and exercise time will be&#xD;
      increased depending upon participant's tolerance. Stretching will consist of ankle stretch&#xD;
      into DF in supine or long sitting, hamstring stretch in supine with hip flexed to 90 degrees,&#xD;
      and trunk extension in sitting.&#xD;
&#xD;
      PRIMARY OBJECTIVE&#xD;
&#xD;
      To determine if individuals diagnosed with a malignancy of the LE can participate in a 10&#xD;
      week preoperative strengthening, stretching, and aerobic exercise regimen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of a 10 week physical therapy intervention program</measure>
    <time_frame>Up to 12 weeks post surgery</time_frame>
    <description>Determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week preoperative strengthening, stretching, and aerobic exercise regimen. We will consider the study to be feasible if at least 60% of the patients are able to complete at least 50% of their scheduled PT sessions.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Osteosarcoma</condition>
  <condition>Ewing's Sarcoma</condition>
  <condition>Rhabdomyosarcoma</condition>
  <condition>Synovial Sarcoma</condition>
  <condition>Malignant Peripheral Nerve Sheath Sarcoma</condition>
  <condition>Malignant Fibrous Histiocytoma of the Bone</condition>
  <condition>Chondrosarcoma of the Bone</condition>
  <arm_group>
    <arm_group_label>Physical Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will receive PT 3 times per week for 60 minutes each session. The therapy sessions will include endurance, strengthening, and stretching exercises.&#xD;
Exercise time and resistance will be progressed per individual's medical status and per participant's tolerance. All participants will be given a tailored home exercise program (HEP).&#xD;
Participants will participate in PT 10 weeks prior to surgery and 10-12 weeks after surgery. Subjects will be seen by the physical therapist both when inpatient and outpatient. Patients will not be seen for PT if platelet count is less than 20,000mm3 and/or hemoglobin is less than 8g/dL.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Endurance</intervention_name>
    <description>Endurance exercise will consist of ambulating with assistive devices as needed, upper extremity (UE) ergometer, and/or playing the Wii.</description>
    <arm_group_label>Physical Therapy</arm_group_label>
    <other_name>Physical therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strengthening</intervention_name>
    <description>Strengthening exercises will involve both UE's and LE's. For UE's, bicep curls, triceps curls, shoulder flexion, and/or press-ups from the therapy mat or wheelchair will be included. For the LE's, bridging, long arc quads, hamstring curls, calf raises in standing, single LE squats, and/or dorsiflexion (DF) in supine will be performed on the uninvolved extremity.</description>
    <arm_group_label>Physical Therapy</arm_group_label>
    <other_name>Physical therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stretching</intervention_name>
    <description>Stretching will consist of ankle stretch into DF in supine or long sitting, hamstring stretch in supine with hip flexed to 90 degrees, and trunk extension in sitting.</description>
    <arm_group_label>Physical Therapy</arm_group_label>
    <other_name>Physical therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home exercise program</intervention_name>
    <description>All participants will be given a tailored home exercise program (HEP) including endurance exercises, strengthening, and stretching exercises to be completed on days they do not have PT. If the participants return home, they will be asked to complete the HEP at least 3 days per week. The physical therapist will contact the participant weekly to modify the HEP if necessary and determine compliance.</description>
    <arm_group_label>Physical Therapy</arm_group_label>
    <other_name>Physical therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient being treated at St. Jude Children's Research Hospital&#xD;
&#xD;
          -  Permission from participant's physician&#xD;
&#xD;
          -  Participants must be between the ages of 6 and 30 years of age&#xD;
&#xD;
          -  Patient is newly diagnosed with LE malignancy as shown by biopsy. Diagnoses include:&#xD;
             osteosarcoma, Ewing's sarcoma, rhabdomyosarcoma, synovial sarcoma, malignant&#xD;
             peripheral nerve sheath sarcoma, malignant fibrous histiocytoma of the bone and&#xD;
             chondrosarcoma of the bone, or any other LE malignancy that requires surgical&#xD;
             intervention.&#xD;
&#xD;
          -  Patient has Karnofsky score ≥ 50 or WHO/ECOG ≤ 2 if ≥ 16 years of age&#xD;
&#xD;
          -  Lansky score ≥ 50 for patients age &lt; 16&#xD;
&#xD;
          -  Surgical intervention is planned primary mechanism of local control&#xD;
&#xD;
          -  Negative pregnancy test&#xD;
&#xD;
          -  All patients and/or their parents or legal guardians must sign a written informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with serious, non-healing wound, ulcer or bone fracture (other than&#xD;
             pathologic fracture)&#xD;
&#xD;
          -  Pre-morbid condition that prevents patient from ambulating&#xD;
&#xD;
          -  Patients who do not have at least 10 weeks before receiving local control&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angela M. Corr, PT, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Jude Children's Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.stjude.org</url>
    <description>St. Jude Children's Research Hospital</description>
  </link>
  <link>
    <url>http://www.stjude.org/protocols</url>
    <description>Clinical Trials Open at St. Jude</description>
  </link>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>December 3, 2015</last_update_submitted>
  <last_update_submitted_qc>December 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lower extremity malignancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Osteosarcoma</mesh_term>
    <mesh_term>Rhabdomyosarcoma</mesh_term>
    <mesh_term>Sarcoma, Ewing</mesh_term>
    <mesh_term>Chondrosarcoma</mesh_term>
    <mesh_term>Sarcoma, Synovial</mesh_term>
    <mesh_term>Histiocytoma</mesh_term>
    <mesh_term>Histiocytoma, Benign Fibrous</mesh_term>
    <mesh_term>Histiocytoma, Malignant Fibrous</mesh_term>
  </condition_browse>
  <!-- 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/NCT01674101
org study id: PTSARC
secondary id: TPTA (YR 1)
secondary id: NCI-2012-01920
nct id: NCT01674101
lead sponsor: 
collaborator: 
has dmc: No
This application proposes a prospective clinical trial to evaluate the impact of adding a
      focused physical therapy (PT) intervention to the preoperative regimen of individuals
      diagnosed with a malignancy of the lower extremity (LE). The primary aim will be to determine
      if individuals diagnosed with a malignancy of the LE can participate in a 10 week
      preoperative strengthening, stretching, and aerobic exercise regimen.
The intervention group will receive PT 3 times per week for 60 minutes each session. The
      therapy sessions will include endurance, strengthening, and stretching exercises. Endurance
      exercises will consist of ambulating with assistive devices as needed, using the upper
      extremity (UE) ergometer, and/or playing the Wii. Strengthening exercises will involve both
      UE's and LE's. For UE's, bicep curls, triceps curls, shoulder flexion, and/or press-ups from
      the therapy mat or wheelchair will be included. For the LE's, bridging, long arc quads,
      hamstring curls, calf raises in standing, single LE squats, and/or dorsiflexion (DF) in
      supine will be performed on the uninvolved extremity. Resistance and exercise time will be
      increased depending upon participant's tolerance. Stretching will consist of ankle stretch
      into DF in supine or long sitting, hamstring stretch in supine with hip flexed to 90 degrees,
      and trunk extension in sitting.

      PRIMARY OBJECTIVE

      To determine if individuals diagnosed with a malignancy of the LE can participate in a 10
      week preoperative strengthening, stretching, and aerobic exercise regimen.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of a 10 week physical therapy intervention program
time frame: Up to 12 weeks post surgery
description: Determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week preoperative strengthening, stretching, and aerobic exercise regimen. We will consider the study to be feasible if at least 60% of the patients are able to complete at least 50% of their scheduled PT sessions.
arm group label: Physical Therapy
arm group type: Experimental
description: The intervention group will receive PT 3 times per week for 60 minutes each session. The therapy sessions will include endurance, strengthening, and stretching exercises.
Exercise time and resistance will be progressed per individual's medical status and per participant's tolerance. All participants will be given a tailored home exercise program (HEP).
Participants will participate in PT 10 weeks prior to surgery and 10-12 weeks after surgery. Subjects will be seen by the physical therapist both when inpatient and outpatient. Patients will not be seen for PT if platelet count is less than 20,000mm3 and/or hemoglobin is less than 8g/dL.
intervention type: Other
intervention name: Endurance
description: Endurance exercise will consist of ambulating with assistive devices as needed, upper extremity (UE) ergometer, and/or playing the Wii.
arm group label: Physical Therapy
other name: Physical therapy
intervention type: Other
intervention name: Strengthening
description: Strengthening exercises will involve both UE's and LE's. For UE's, bicep curls, triceps curls, shoulder flexion, and/or press-ups from the therapy mat or wheelchair will be included. For the LE's, bridging, long arc quads, hamstring curls, calf raises in standing, single LE squats, and/or dorsiflexion (DF) in supine will be performed on the uninvolved extremity.
arm group label: Physical Therapy
other name: Physical therapy
intervention type: Other
intervention name: Stretching
description: Stretching will consist of ankle stretch into DF in supine or long sitting, hamstring stretch in supine with hip flexed to 90 degrees, and trunk extension in sitting.
arm group label: Physical Therapy
other name: Physical therapy
intervention type: Other
intervention name: Home exercise program
description: All participants will be given a tailored home exercise program (HEP) including endurance exercises, strengthening, and stretching exercises to be completed on days they do not have PT. If the participants return home, they will be asked to complete the HEP at least 3 days per week. The physical therapist will contact the participant weekly to modify the HEP if necessary and determine compliance.
arm group label: Physical Therapy
other name: Physical therapy
criteria: 
gender: All
minimum age: 6 Years
maximum age: 30 Years
healthy volunteers: No
last name: Angela M. Corr, PT, DPT
role: Principal Investigator
affiliation: St. Jude Children's Research Hospital
facility: 
country: United States
url: http://www.stjude.org
description: St. Jude Children's Research Hospital
url: http://www.stjude.org/protocols
description: Clinical Trials Open at St. Jude
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Sarcoma
mesh term: Osteosarcoma
mesh term: Rhabdomyosarcoma
mesh term: Sarcoma, Ewing
mesh term: Chondrosarcoma
mesh term: Sarcoma, Synovial
mesh term: Histiocytoma
mesh term: Histiocytoma, Benign Fibrous
mesh term: Histiocytoma, Malignant Fibrous