<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/NCT03228719</url>
  </required_header>
  <id_info>
    <org_study_id>946165-97</org_study_id>
    <nct_id>NCT03228719</nct_id>
  </id_info>
  <brief_title>A Physical Therapist Administered Physical Activity Intervention After Total Knee Replacement</brief_title>
  <official_title>A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Delaware</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Delaware</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Background: The definitive treatment for knee osteoarthritis is Total Knee Replacement (TKR),&#xD;
      which results in clinically meaningful improvements in pain and physical function. However,&#xD;
      evidence suggests that physical activity remains unchanged after TKR. This randomized&#xD;
      clinical trial is investigating the efficacy, fidelity, and safety of a physical therapist&#xD;
      administered physical activity intervention for people after TKR.&#xD;
&#xD;
      Methods/Design: One hundred and twenty-five individuals, over the age of 45, who seek&#xD;
      outpatient Physical Therapy (PT) following a unilateral TKR will be randomized into a control&#xD;
      and intervention group. The intervention group will receive a weekly physical activity&#xD;
      intervention during PT, which includes a FitbitTM monitor, individualized step goals, and&#xD;
      face-to-face feedback provided by the physical therapist. Efficacy of the intervention will&#xD;
      be measured by minutes/week spent in Moderate-to-Vigorous Physical Activity (MPVA) using an&#xD;
      Actigraph GT3X monitor from enrollment to discharge, 6 months and 12 months from discharge&#xD;
      from PT. The association of self-efficacy for exercise and kinesiophobia with physical&#xD;
      activity will also be measured at the same time points. Fidelity and safety of the&#xD;
      intervention will be assessed during outpatient PT.&#xD;
&#xD;
      Discussion: This study is designed to fill a critical clinical need to increase physical&#xD;
      activity after TKR. The primary objective of the study is to evaluate the efficacy of a&#xD;
      physical therapist administered physical activity intervention for people after TKR. The&#xD;
      secondary objectives are to evaluate the fidelity and safety of a physical therapist&#xD;
      administered physical activity intervention for people after TKR and to investigate changes&#xD;
      in self-reported and performance-based physical function after a physical therapist&#xD;
      administered physical activity intervention for people after TKR. The tertiary objective is&#xD;
      to explore the association of psychosocial factors with physical activity 6 and 12 months&#xD;
      after discharge from a physical therapist administered physical activity intervention for&#xD;
      people after TKR. The findings will be used to support a large multi-site clinical trial to&#xD;
      test the effectiveness, implementation, and cost of this intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Actual">April 21, 2022</completion_date>
  <primary_completion_date type="Actual">October 4, 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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Activity measured by an Actigraph GT3X Monitor</measure>
    <time_frame>Change from baseline physical activity (initial PT evaluation), to discharge from PT (proximately 6-8 weeks after starting PT), to 6 months from PT discharge and to 12 months from PT discharge</time_frame>
    <description>Time spent in Moderate to Vigorous Physical Activity (MVPA) average minutes/week. Hypothesize intervention group will spend 30 minutes or more in MVPA minutes/week than the control group and each of the follow-up time points</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fidelity of the Physical Activity Intervention</measure>
    <time_frame>At enrollment (initial physical therapy evaluation) to discharge from physical therapy (proximately 6-8 weeks after starting physical therapy)</time_frame>
    <description>Intervention fidelity will measure the adherence of implementing the physical activity intervention in PT practice. This will be measured by reviewing the participant's home exercise program. We will check if the physical therapist documented that they reviewed the participant's physical activity using the FitbitTM and to see if they reviewed the individualized step goal with the participant in the home exercise program log.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of the Physical Activity Intervention</measure>
    <time_frame>AE that occur from enrollment to 12-months will document the safety of the intervention.</time_frame>
    <description>Safety will be measured by documenting Adverse Events (AE). An AE is defined as any unfavorable or unintended diagnosis, sign, symptom, or disease associated with the study which may or may not be related to the intervention. In the case of a major AE the principal investigator (PI) and the University of Delaware Internal Review Board (IRB) will be notified immediately. Pre-enrollment AEs will not be included in the safety assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Reported Physical Function on the Knee Outcome Survey</measure>
    <time_frame>At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy),</time_frame>
    <description>Self-reported physical function will be measured on the Knee Outcome Survey (KOS). These measures will be collected via medical chart review by a research assistant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Reported Physical Function on the Physical Component Summary of the Short Form Survey SF-36</measure>
    <time_frame>At enrollment (initial physical therapy evaluation), 6 months from discharging from PT, and 12 months from discharging from PT</time_frame>
    <description>Self-reported physical function will be measured Physical Component Summary of the Short Form Survey SF-36. These measures will be collected via medical chart review by a research assistant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Measure of Physical Function on the 6 Minute Walk Test</measure>
    <time_frame>At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy),</time_frame>
    <description>Objective physical function will be measured using walking endurance on the 6 minute walk test (6MWT). These measures will be collected via medical chart review by a research assistant.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-reported kinesiophobia on the Fear of Movement Scale for Osteoarthritis (FMSO)</measure>
    <time_frame>At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy),</time_frame>
    <description>Measure of kinesiophobia for activity on the FMSO</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-reported self-efficacy using the Self-Efficacy for Exercise (SEE)</measure>
    <time_frame>At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy),</time_frame>
    <description>Measure self-efficacy for exercise on the SEE</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standardized Outpatient Physical Therapy after TKR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standardized Outpatient Physical Therapy after TKR with a Physical Activity Intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standardize PT after TKR with a Physical Activity Intervention</intervention_name>
    <description>Standardized PT and a physical activity intervention. Participants will be provided a FitbitTM Zip within one week after enrolling in the study. Participants will self-track their steps/day using their FitbitTM Zip. Participants ≤ 3 weeks' post-operative TKR are expected to maintain and not increase steps/day. Beyond 3 weeks after surgery, step goals will be initiated and evaluated on a weekly basis. Progression of weekly steps/day goal will be a joint decision between the participant and physical therapist. As a guide, a 10-20% increase in steps/day until at least 6,000 steps/day is achieved. Each week the physical therapist will review the participant's steps/day goal and if at least 4 of the 7 previous days per week were at or above the prior week's steps/day goal, then next week's steps/day goal will increase. The physical therapist will discuss current steps/day with the participant using the Fitbit TM Zip and set a personalized steps/day goal each week during PT.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standardized PT after TKR</intervention_name>
    <description>Participants in the control group will receive standardized PT provided by a licensed physical therapist at UDPT using the University of Delaware's Rehabilitation Guidelines for Unilateral Total Knee Replacement. Standardized PT also includes a printed home exercise program with an exercise log that is updated weekly by a physical therapist. PT appointment times range from 45-60 minutes with appointment occurring 1-3 times a week for 6-8 weeks.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Over the age of 45&#xD;
&#xD;
          2. Seeking outpatient physical therapy for a unilateral TKR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Not interested in increasing physical activity&#xD;
&#xD;
          2. Any other medical conditions that limit your physical activity&#xD;
&#xD;
          3. Have had or are planning on having another leg surgery within 6 months that is&#xD;
             unrelated to your TKR surgery&#xD;
&#xD;
          4. Previously enrolled in a physical activity intervention study at this clinic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel K White, PT, ScD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Delaware</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Delaware</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Delaware</investigator_affiliation>
    <investigator_full_name>Daniel K. White</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Total Knee Replacement</keyword>
  <keyword>Physical Therapy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 14, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03228719/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 28, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03228719/SAP_005.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03228719/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>April 9, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03228719
org study id: 946165-97
nct id: NCT03228719
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: The definitive treatment for knee osteoarthritis is Total Knee Replacement (TKR),
      which results in clinically meaningful improvements in pain and physical function. However,
      evidence suggests that physical activity remains unchanged after TKR. This randomized
      clinical trial is investigating the efficacy, fidelity, and safety of a physical therapist
      administered physical activity intervention for people after TKR.

      Methods/Design: One hundred and twenty-five individuals, over the age of 45, who seek
      outpatient Physical Therapy (PT) following a unilateral TKR will be randomized into a control
      and intervention group. The intervention group will receive a weekly physical activity
      intervention during PT, which includes a FitbitTM monitor, individualized step goals, and
      face-to-face feedback provided by the physical therapist. Efficacy of the intervention will
      be measured by minutes/week spent in Moderate-to-Vigorous Physical Activity (MPVA) using an
      Actigraph GT3X monitor from enrollment to discharge, 6 months and 12 months from discharge
      from PT. The association of self-efficacy for exercise and kinesiophobia with physical
      activity will also be measured at the same time points. Fidelity and safety of the
      intervention will be assessed during outpatient PT.

      Discussion: This study is designed to fill a critical clinical need to increase physical
      activity after TKR. The primary objective of the study is to evaluate the efficacy of a
      physical therapist administered physical activity intervention for people after TKR. The
      secondary objectives are to evaluate the fidelity and safety of a physical therapist
      administered physical activity intervention for people after TKR and to investigate changes
      in self-reported and performance-based physical function after a physical therapist
      administered physical activity intervention for people after TKR. The tertiary objective is
      to explore the association of psychosocial factors with physical activity 6 and 12 months
      after discharge from a physical therapist administered physical activity intervention for
      people after TKR. The findings will be used to support a large multi-site clinical trial to
      test the effectiveness, implementation, and cost of this intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Physical Activity measured by an Actigraph GT3X Monitor
time frame: Change from baseline physical activity (initial PT evaluation), to discharge from PT (proximately 6-8 weeks after starting PT), to 6 months from PT discharge and to 12 months from PT discharge
description: Time spent in Moderate to Vigorous Physical Activity (MVPA) average minutes/week. Hypothesize intervention group will spend 30 minutes or more in MVPA minutes/week than the control group and each of the follow-up time points
measure: Fidelity of the Physical Activity Intervention
time frame: At enrollment (initial physical therapy evaluation) to discharge from physical therapy (proximately 6-8 weeks after starting physical therapy)
description: Intervention fidelity will measure the adherence of implementing the physical activity intervention in PT practice. This will be measured by reviewing the participant's home exercise program. We will check if the physical therapist documented that they reviewed the participant's physical activity using the FitbitTM and to see if they reviewed the individualized step goal with the participant in the home exercise program log.
measure: Safety of the Physical Activity Intervention
time frame: AE that occur from enrollment to 12-months will document the safety of the intervention.
description: Safety will be measured by documenting Adverse Events (AE). An AE is defined as any unfavorable or unintended diagnosis, sign, symptom, or disease associated with the study which may or may not be related to the intervention. In the case of a major AE the principal investigator (PI) and the University of Delaware Internal Review Board (IRB) will be notified immediately. Pre-enrollment AEs will not be included in the safety assessment.
measure: Self-Reported Physical Function on the Knee Outcome Survey
time frame: At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy),
description: Self-reported physical function will be measured on the Knee Outcome Survey (KOS). These measures will be collected via medical chart review by a research assistant.
measure: Self-Reported Physical Function on the Physical Component Summary of the Short Form Survey SF-36
time frame: At enrollment (initial physical therapy evaluation), 6 months from discharging from PT, and 12 months from discharging from PT
description: Self-reported physical function will be measured Physical Component Summary of the Short Form Survey SF-36. These measures will be collected via medical chart review by a research assistant.
measure: Objective Measure of Physical Function on the 6 Minute Walk Test
time frame: At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy),
description: Objective physical function will be measured using walking endurance on the 6 minute walk test (6MWT). These measures will be collected via medical chart review by a research assistant.
measure: Self-reported kinesiophobia on the Fear of Movement Scale for Osteoarthritis (FMSO)
time frame: At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy),
description: Measure of kinesiophobia for activity on the FMSO
measure: Self-reported self-efficacy using the Self-Efficacy for Exercise (SEE)
time frame: At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy),
description: Measure self-efficacy for exercise on the SEE
arm group label: Control Group
arm group type: Active Comparator
description: Standardized Outpatient Physical Therapy after TKR
arm group label: Intervention Group
arm group type: Experimental
description: Standardized Outpatient Physical Therapy after TKR with a Physical Activity Intervention
intervention type: Behavioral
intervention name: Standardize PT after TKR with a Physical Activity Intervention
description: Standardized PT and a physical activity intervention. Participants will be provided a FitbitTM Zip within one week after enrolling in the study. Participants will self-track their steps/day using their FitbitTM Zip. Participants ≤ 3 weeks' post-operative TKR are expected to maintain and not increase steps/day. Beyond 3 weeks after surgery, step goals will be initiated and evaluated on a weekly basis. Progression of weekly steps/day goal will be a joint decision between the participant and physical therapist. As a guide, a 10-20% increase in steps/day until at least 6,000 steps/day is achieved. Each week the physical therapist will review the participant's steps/day goal and if at least 4 of the 7 previous days per week were at or above the prior week's steps/day goal, then next week's steps/day goal will increase. The physical therapist will discuss current steps/day with the participant using the Fitbit TM Zip and set a personalized steps/day goal each week during PT.
arm group label: Intervention Group
intervention type: Other
intervention name: Standardized PT after TKR
description: Participants in the control group will receive standardized PT provided by a licensed physical therapist at UDPT using the University of Delaware's Rehabilitation Guidelines for Unilateral Total Knee Replacement. Standardized PT also includes a printed home exercise program with an exercise log that is updated weekly by a physical therapist. PT appointment times range from 45-60 minutes with appointment occurring 1-3 times a week for 6-8 weeks.
arm group label: Control Group
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel K White, PT, ScD, MSc
role: Principal Investigator
affiliation: University of Delaware
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Delaware
investigator full name: Daniel K. White
investigator title: Associate Professor
sharing ipd: No
provided document: 
provided document: 
provided document: 
submitted: April 9, 2023