<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/NCT03768206</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00081254</org_study_id>
    <nct_id>NCT03768206</nct_id>
  </id_info>
  <brief_title>The PATH Study to Promote Physical Activity After Knee Replacement</brief_title>
  <official_title>Promoting Physical Activity Via Physical Therapist Following Knee Replacement- The PATH Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prisma Health-Midlands</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Carolina</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 purpose of this study is to examine the feasibility and preliminary efficacy of a&#xD;
      physical therapist led physical activity intervention for knee replacement patients within an&#xD;
      outpatient physical therapy facility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical activity does not typically increase after knee replacement; thus, the purpose of&#xD;
      this study is to examine if physical activity levels will be higher among knee replacement&#xD;
      patients who receive a physical therapist led physical activity intervention during standard&#xD;
      physical therapy sessions. Physical activity levels will be assessed at the start of&#xD;
      outpatient therapy and at 12 weeks after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">June 15, 2020</completion_date>
  <primary_completion_date type="Actual">June 15, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Enrolled</measure>
    <time_frame>Baseline</time_frame>
    <description>Feasibility will be determined based on the number of participants enrolled vs. the number approached</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Complete the 12 Week Assessment</measure>
    <time_frame>12 weeks</time_frame>
    <description>Acceptability will be determined by the percentage of participants completing the 12 week assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Moderate-Vigorous Intensity Physical Activity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Total number of minutes of objectively-measured moderate-vigorous intensity (&gt;2020 counts/min) physical activity/week assessed using Actigraph link activity monitors worn around the waist for 7 days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>PATH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity &amp; assist with goal setting during therapy sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PATH-12</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Physical Therapy</intervention_name>
    <description>Participants will receive standard outpatient physical therapy that is typical following knee replacement</description>
    <arm_group_label>PATH</arm_group_label>
    <arm_group_label>PATH-12</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical therapist discuss aerobic physical activity</intervention_name>
    <description>Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.</description>
    <arm_group_label>PATH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical activity session</intervention_name>
    <description>Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.</description>
    <arm_group_label>PATH-12</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be 40-79 years of age&#xD;
&#xD;
          -  Have had a knee replacement in the last 2 months&#xD;
&#xD;
          -  Be willing to wear and accelerometer for 7 days during assessments&#xD;
&#xD;
          -  Be English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any contraindications to activity&#xD;
&#xD;
          -  Have a mobility limiting comorbidity&#xD;
&#xD;
          -  Have a scheduled surgery within the next 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Pellegrini, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Palmetto Health- USC Orthopedic Center</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Carolina</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>June 7, 2021</results_first_submitted>
  <results_first_submitted_qc>June 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 19, 2021</results_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of South Carolina</investigator_affiliation>
    <investigator_full_name>Christine A Pellegrini, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>knee arthroplasty</keyword>
  <keyword>behavioral intervention</keyword>
  <keyword>physical activity</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Given the preliminary nature of the study and small sample size, we do not plan to share data with others, unless requested to do so.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03768206/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>PATH</title>
          <description>PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity &amp; assist with goal setting during therapy sessions.&#xD;
Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement&#xD;
Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.</description>
        </group>
        <group group_id="P2">
          <title>PATH-12</title>
          <description>PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery.&#xD;
Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement&#xD;
Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PATH</title>
          <description>PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity &amp; assist with goal setting during therapy sessions.&#xD;
Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement&#xD;
Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.</description>
        </group>
        <group group_id="B2">
          <title>PATH-12</title>
          <description>PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery.&#xD;
Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement&#xD;
Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.2" spread="5.4"/>
                    <measurement group_id="B2" value="63.3" spread="8.1"/>
                    <measurement group_id="B3" value="65.4" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Moderate-vigorous intensity physical activity</title>
          <population>Participants were only included if they had 4 valid days of at least 10 hours of wear time</population>
          <units>minutes/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.8" spread="56.8"/>
                    <measurement group_id="B2" value="23.5" spread="22.3"/>
                    <measurement group_id="B3" value="31.5" spread="45.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Enrolled</title>
        <description>Feasibility will be determined based on the number of participants enrolled vs. the number approached</description>
        <time_frame>Baseline</time_frame>
        <population>The overall number of participants analyzed reflects the total number of participants that were approached and screened for participation</population>
        <group_list>
          <group group_id="O1">
            <title>Total Participants Approached</title>
            <description>The total number of participants that were screened for participation in the study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Enrolled</title>
          <description>Feasibility will be determined based on the number of participants enrolled vs. the number approached</description>
          <population>The overall number of participants analyzed reflects the total number of participants that were approached and screened for participation</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Complete the 12 Week Assessment</title>
        <description>Acceptability will be determined by the percentage of participants completing the 12 week assessment.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PATH</title>
            <description>PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity &amp; assist with goal setting during therapy sessions.&#xD;
Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement&#xD;
Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.</description>
          </group>
          <group group_id="O2">
            <title>PATH-12</title>
            <description>PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery.&#xD;
Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement&#xD;
Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Complete the 12 Week Assessment</title>
          <description>Acceptability will be determined by the percentage of participants completing the 12 week assessment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Moderate-Vigorous Intensity Physical Activity</title>
        <description>Total number of minutes of objectively-measured moderate-vigorous intensity (&gt;2020 counts/min) physical activity/week assessed using Actigraph link activity monitors worn around the waist for 7 days.</description>
        <time_frame>12 weeks</time_frame>
        <population>Only participants with 4 valid days of activity monitor wear (at least 10 hours of wear time) were included in analyses</population>
        <group_list>
          <group group_id="O1">
            <title>PATH</title>
            <description>PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity &amp; assist with goal setting during therapy sessions.&#xD;
Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement&#xD;
Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.</description>
          </group>
          <group group_id="O2">
            <title>PATH-12</title>
            <description>PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery.&#xD;
Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement&#xD;
Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.</description>
          </group>
        </group_list>
        <measure>
          <title>Moderate-Vigorous Intensity Physical Activity</title>
          <description>Total number of minutes of objectively-measured moderate-vigorous intensity (&gt;2020 counts/min) physical activity/week assessed using Actigraph link activity monitors worn around the waist for 7 days.</description>
          <population>Only participants with 4 valid days of activity monitor wear (at least 10 hours of wear time) were included in analyses</population>
          <units>minutes/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.5" spread="55.4"/>
                    <measurement group_id="O2" value="57.4" spread="62.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>PATH</title>
          <description>PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity &amp; assist with goal setting during therapy sessions.&#xD;
Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement&#xD;
Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.</description>
        </group>
        <group group_id="E2">
          <title>PATH-12</title>
          <description>PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery.&#xD;
Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement&#xD;
Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Christine Pellegrini</name_or_title>
      <organization>University of South Carolina</organization>
      <phone>803-777-0911</phone>
      <email>pellegca@mailbox.sc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03768206
org study id: Pro00081254
nct id: NCT03768206
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the feasibility and preliminary efficacy of a
      physical therapist led physical activity intervention for knee replacement patients within an
      outpatient physical therapy facility.
Physical activity does not typically increase after knee replacement; thus, the purpose of
      this study is to examine if physical activity levels will be higher among knee replacement
      patients who receive a physical therapist led physical activity intervention during standard
      physical therapy sessions. Physical activity levels will be assessed at the start of
      outpatient therapy and at 12 weeks after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Enrolled
time frame: Baseline
description: Feasibility will be determined based on the number of participants enrolled vs. the number approached
measure: Percentage of Participants Who Complete the 12 Week Assessment
time frame: 12 weeks
description: Acceptability will be determined by the percentage of participants completing the 12 week assessment.
measure: Moderate-Vigorous Intensity Physical Activity
time frame: 12 weeks
description: Total number of minutes of objectively-measured moderate-vigorous intensity (>2020 counts/min) physical activity/week assessed using Actigraph link activity monitors worn around the waist for 7 days.
arm group label: PATH
arm group type: Experimental
description: PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions.
arm group label: PATH-12
arm group type: Active Comparator
description: PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery.
intervention type: Behavioral
intervention name: Standard Physical Therapy
description: Participants will receive standard outpatient physical therapy that is typical following knee replacement
arm group label: PATH
arm group label: PATH-12
intervention type: Behavioral
intervention name: Physical therapist discuss aerobic physical activity
description: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.
arm group label: PATH
intervention type: Behavioral
intervention name: Physical activity session
description: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.
arm group label: PATH-12
criteria: 
gender: All
minimum age: 40 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christine Pellegrini, phD
role: Principal Investigator
affiliation: University of South Carolina
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of South Carolina
investigator full name: Christine A Pellegrini, PhD
investigator title: Assistant Professor
sharing ipd: No
ipd description: Given the preliminary nature of the study and small sample size, we do not plan to share data with others, unless requested to do so.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 