xml: <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/NCT05983380</url>
    </required_header>
    <id_info>
      <org_study_id>FY2023-183</org_study_id>
      <nct_id>NCT05983380</nct_id>
    </id_info>
    <brief_title>The Effect of Hand Exercises on Upper Limb Volume, Quality of Life, and Hand Function in Breast Cancer Survivors</brief_title>
    <official_title>The Effect of Hand Mobility and Grip Strengthening Exercises on Upper Limb Volume, Quality of Life, and Hand Function in Breast Cancer Survivors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Texas Woman's University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Presbyterian Healthcare Services</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Texas Woman's University</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 determine whether the addition of simple hand mobility and&#xD;
        grip strengthening exercises to the usual care for upper extremity lymphedema will reduce&#xD;
        limb volume and improve the quality of life, hand dexterity, and grip strength for those&#xD;
        experiencing breast cancer-related lymphedema. Researchers will compare those receiving the&#xD;
        usual treatment to those receiving the usual treatment plus hand mobility and grip&#xD;
        strengthening exercises.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to determine whether the addition of simple hand mobility and&#xD;
        grip strengthening exercises to the usual care for upper extremity lymphedema will reduce&#xD;
        limb volume and improve the quality of life, hand dexterity, and grip strength for those&#xD;
        experiencing early, moderate, or late stage breast cancer-related lymphedema.&#xD;
  &#xD;
        This study is an experimental clinical trial to determine the effectiveness of hand mobility&#xD;
        and grip exercises on limb volume, quality of life, hand dexterity, and grip strength in&#xD;
        women with breast cancer-related lymphedema. The two independent variables are group, a&#xD;
        between-subject factor, and time, a within subject factor. There are two levels of the&#xD;
        independent variable of group: (1)usual care plus hand exercises and (2) usual care alone.&#xD;
        The independent variable of time will be assessed at three timepoints: initial to 4 weeks, 4&#xD;
        to 8 weeks, and initial to 8 weeks of intervention. The four dependent variables are: (1)&#xD;
        upper limb volume, (2) quality of life, (3) hand dexterity, and (4) grip strength. If a&#xD;
        relationship (r&gt;0.5) is found between any of the dependent variables, MANOVA will used for&#xD;
        analysis. If no relationship is found, a 2x3 mixed ANOVA will be used to analyze each&#xD;
        dependent variable without a significant relationship to the others. The comparison group&#xD;
        will receive the usual physical or occupational therapy treatment, including compression&#xD;
        bandaging, manual lymphatic drainage, shoulder and scapular muscle exercises, and education&#xD;
        regarding skin hygiene and monitoring. The experimental group will receive the usual&#xD;
        treatment plus additional hand mobility and grip strengthening exercises.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 18, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Two groups will be compared, with treatment occurring at the same time. One group will receive the experimental exercises plus the usual treatment, the comparison group will only receive the usual treatment for breast cancer-related lymphedema.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participants will be masked regarding whether they are assigned to the intervention or comparison group.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Upper Limb volume</measure>
      <time_frame>Day 1, at 4 weeks, at 8 weeks of treatment/completion of study.</time_frame>
      <description>Circumferential measurements of the upper limb, converted to volumetric measurements with frustrum equation through Epic EMR.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Grip Strength</measure>
      <time_frame>Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.</time_frame>
      <description>Grip Strength assessed with Jamar Hand Dynamometer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nine-Hole Peg Test</measure>
      <time_frame>Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.</time_frame>
      <description>Nine-Hole Peg Test with affected limb only to assess dexterity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lymphedema Life Impact Scale</measure>
      <time_frame>Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.</time_frame>
      <description>Participants fill out Lymphedema Life Impact Scale, a self-report survey to assess quality of life.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Breast Cancer Lymphedema</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive hand mobility and grip strengthening exercises in addition to the usual care for breast cancer-related lymphedema of the upper limb.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Comparison</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive only the usual care for breast cancer-related lymphedema.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Hand Mobility and Grip Strengthening Exercises</intervention_name>
      <description>Addition of hand mobility and grip strengthening exercises to the usual care for breast cancer-related lymphedema to assess changes in limb volume, quality of life, and hand function.</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Usual Care</intervention_name>
      <description>Manual lymphatic drainage, compression, exercise, skin hygiene.</description>
      <arm_group_label>Comparison</arm_group_label>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Biologic women age 18 years or older with a diagnosis of clinical lymphedema of one&#xD;
               upper extremity-early (clinical), moderate, or late stage, following treatment for&#xD;
               breast cancer within the previous 10 years.&#xD;
  &#xD;
            -  Women concurrently receiving immunotherapy or chemotherapy are eligible for inclusion,&#xD;
               but an additional information request may be necessary (e.g., any activity&#xD;
               restrictions and nadir periods) to determine whether they can safely participate in&#xD;
               the exercise activities and apply compression.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior history of paresis in either upper limb, though paresis related to nerve&#xD;
               compression from increased lymphatic volume will be eligible for inclusion.&#xD;
  &#xD;
            -  Current open wounds (&gt; 0.5 inch in length or diameter) of the axilla or edematous&#xD;
               upper limb would be excluded, though the presence of lymphorrhea without visible skin&#xD;
               tears will be eligible for inclusion.&#xD;
  &#xD;
            -  Previous treatment for upper limb lymphedema or a prior diagnosis of congestive heart&#xD;
               failure or end-stage renal disease due to the impact on edematous limbs and risk of&#xD;
               cardiac overload.&#xD;
  &#xD;
            -  Women who cannot speak or read English or Spanish sufficiently to complete the&#xD;
               Lymphedema Life Impact Scale or understand the consent forms, educational information,&#xD;
               and printed exercises will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Biologic women due to increased prevalence of breast cancer diagnosis.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elisabeth Wise, DPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Texas Woman's University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elisabeth Wise, DPT</last_name>
      <phone>505-772-1770</phone>
      <email>EWise@phs.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tiffany Ryan, MOT/R</last_name>
      <phone>505-772-1775</phone>
      <email>TRyan3@phs.org</email>
    </overall_contact_backup>
    <reference>
      <citation>Ahmad FB, Anderson RN. The Leading Causes of Death in the US for 2020. JAMA. 2021 May 11;325(18):1829-1830. doi: 10.1001/jama.2021.5469. No abstract available.</citation>
      <PMID>33787821</PMID>
    </reference>
    <reference>
      <citation>Ahmed RL, Prizment A, Lazovich D, Schmitz KH, Folsom AR. Lymphedema and quality of life in breast cancer survivors: the Iowa Women's Health Study. J Clin Oncol. 2008 Dec 10;26(35):5689-96. doi: 10.1200/JCO.2008.16.4731. Epub 2008 Nov 10.</citation>
      <PMID>19001331</PMID>
    </reference>
    <reference>
      <citation>Chromy A, Zalud L, Dobsak P, Suskevic I, Mrkvicova V. Limb volume measurements: comparison of accuracy and decisive parameters of the most used present methods. Springerplus. 2015 Nov 19;4:707. doi: 10.1186/s40064-015-1468-7. eCollection 2015.</citation>
      <PMID>26618096</PMID>
    </reference>
    <reference>
      <citation>Davies C, Levenhagen K, Ryans K, Perdomo M, Gilchrist L. Interventions for Breast Cancer-Related Lymphedema: Clinical Practice Guideline From the Academy of Oncologic Physical Therapy of APTA. Phys Ther. 2020 Jul 19;100(7):1163-1179. doi: 10.1093/ptj/pzaa087.</citation>
      <PMID>32589208</PMID>
    </reference>
    <reference>
      <citation>De Groef A, Van Kampen M, Dieltjens E, Christiaens MR, Neven P, Geraerts I, Devoogdt N. Effectiveness of postoperative physical therapy for upper-limb impairments after breast cancer treatment: a systematic review. Arch Phys Med Rehabil. 2015 Jun;96(6):1140-53. doi: 10.1016/j.apmr.2015.01.006. Epub 2015 Jan 13.</citation>
      <PMID>25595999</PMID>
    </reference>
    <reference>
      <citation>Feys P, Lamers I, Francis G, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. The Nine-Hole Peg Test as a manual dexterity performance measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):711-720. doi: 10.1177/1352458517690824. Epub 2017 Feb 16.</citation>
      <PMID>28206826</PMID>
    </reference>
    <reference>
      <citation>Giray E, Akyuz G. Assessment of Family Caregiver Burden and Its Relationships Between Quality of Life, Arm Disability, Grip Strength, and Lymphedema Symptoms in Women with Postmastectomy Lymphedema: A Prospective Cross-Sectional Study. Eur J Breast Health. 2019 Feb 15;15(2):111-118. doi: 10.5152/ejbh.2019.4385. eCollection 2019 Apr.</citation>
      <PMID>31001613</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Texas Woman's University</investigator_affiliation>
      <investigator_full_name>Elisabeth Wise</investigator_full_name>
      <investigator_title>Primary Investigator, Physical Therapist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Lymphedema</mesh_term>
      <mesh_term>Breast Cancer Lymphedema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No plan to share IPD with other researchers.</ipd_description>
    </patient_data>
    <provided_document_section>
      <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>July 11, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT05983380/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05983380
  org study id: FY2023-183
  nct id: NCT05983380
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine whether the addition of simple hand mobility and
        grip strengthening exercises to the usual care for upper extremity lymphedema will reduce
        limb volume and improve the quality of life, hand dexterity, and grip strength for those
        experiencing breast cancer-related lymphedema. Researchers will compare those receiving the
        usual treatment to those receiving the usual treatment plus hand mobility and grip
        strengthening exercises.
  The purpose of this study is to determine whether the addition of simple hand mobility and
        grip strengthening exercises to the usual care for upper extremity lymphedema will reduce
        limb volume and improve the quality of life, hand dexterity, and grip strength for those
        experiencing early, moderate, or late stage breast cancer-related lymphedema.
  
        This study is an experimental clinical trial to determine the effectiveness of hand mobility
        and grip exercises on limb volume, quality of life, hand dexterity, and grip strength in
        women with breast cancer-related lymphedema. The two independent variables are group, a
        between-subject factor, and time, a within subject factor. There are two levels of the
        independent variable of group: (1)usual care plus hand exercises and (2) usual care alone.
        The independent variable of time will be assessed at three timepoints: initial to 4 weeks, 4
        to 8 weeks, and initial to 8 weeks of intervention. The four dependent variables are: (1)
        upper limb volume, (2) quality of life, (3) hand dexterity, and (4) grip strength. If a
        relationship (r>0.5) is found between any of the dependent variables, MANOVA will used for
        analysis. If no relationship is found, a 2x3 mixed ANOVA will be used to analyze each
        dependent variable without a significant relationship to the others. The comparison group
        will receive the usual physical or occupational therapy treatment, including compression
        bandaging, manual lymphatic drainage, shoulder and scapular muscle exercises, and education
        regarding skin hygiene and monitoring. The experimental group will receive the usual
        treatment plus additional hand mobility and grip strengthening exercises.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two groups will be compared, with treatment occurring at the same time. One group will receive the experimental exercises plus the usual treatment, the comparison group will only receive the usual treatment for breast cancer-related lymphedema.
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Participants will be masked regarding whether they are assigned to the intervention or comparison group.
  measure: Upper Limb volume
  time frame: Day 1, at 4 weeks, at 8 weeks of treatment/completion of study.
  description: Circumferential measurements of the upper limb, converted to volumetric measurements with frustrum equation through Epic EMR.
  measure: Grip Strength
  time frame: Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.
  description: Grip Strength assessed with Jamar Hand Dynamometer.
  measure: Nine-Hole Peg Test
  time frame: Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.
  description: Nine-Hole Peg Test with affected limb only to assess dexterity.
  measure: Lymphedema Life Impact Scale
  time frame: Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.
  description: Participants fill out Lymphedema Life Impact Scale, a self-report survey to assess quality of life.
  arm group label: Experimental
  arm group type: Experimental
  description: Participants will receive hand mobility and grip strengthening exercises in addition to the usual care for breast cancer-related lymphedema of the upper limb.
  arm group label: Comparison
  arm group type: Active Comparator
  description: Participants will receive only the usual care for breast cancer-related lymphedema.
  intervention type: Other
  intervention name: Hand Mobility and Grip Strengthening Exercises
  description: Addition of hand mobility and grip strengthening exercises to the usual care for breast cancer-related lymphedema to assess changes in limb volume, quality of life, and hand function.
  arm group label: Experimental
  intervention type: Other
  intervention name: Usual Care
  description: Manual lymphatic drainage, compression, exercise, skin hygiene.
  arm group label: Comparison
  arm group label: Experimental
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Biologic women due to increased prevalence of breast cancer diagnosis.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Elisabeth Wise, DPT
  role: Principal Investigator
  affiliation: Texas Woman's University
  last name: Elisabeth Wise, DPT
  phone: 505-772-1770
  email: EWise@phs.org
  last name: Tiffany Ryan, MOT/R
  phone: 505-772-1775
  email: TRyan3@phs.org
  citation: Ahmad FB, Anderson RN. The Leading Causes of Death in the US for 2020. JAMA. 2021 May 11;325(18):1829-1830. doi: 10.1001/jama.2021.5469. No abstract available.
  PMID: 33787821
  citation: Ahmed RL, Prizment A, Lazovich D, Schmitz KH, Folsom AR. Lymphedema and quality of life in breast cancer survivors: the Iowa Women's Health Study. J Clin Oncol. 2008 Dec 10;26(35):5689-96. doi: 10.1200/JCO.2008.16.4731. Epub 2008 Nov 10.
  PMID: 19001331
  citation: Chromy A, Zalud L, Dobsak P, Suskevic I, Mrkvicova V. Limb volume measurements: comparison of accuracy and decisive parameters of the most used present methods. Springerplus. 2015 Nov 19;4:707. doi: 10.1186/s40064-015-1468-7. eCollection 2015.
  PMID: 26618096
  citation: Davies C, Levenhagen K, Ryans K, Perdomo M, Gilchrist L. Interventions for Breast Cancer-Related Lymphedema: Clinical Practice Guideline From the Academy of Oncologic Physical Therapy of APTA. Phys Ther. 2020 Jul 19;100(7):1163-1179. doi: 10.1093/ptj/pzaa087.
  PMID: 32589208
  citation: De Groef A, Van Kampen M, Dieltjens E, Christiaens MR, Neven P, Geraerts I, Devoogdt N. Effectiveness of postoperative physical therapy for upper-limb impairments after breast cancer treatment: a systematic review. Arch Phys Med Rehabil. 2015 Jun;96(6):1140-53. doi: 10.1016/j.apmr.2015.01.006. Epub 2015 Jan 13.
  PMID: 25595999
  citation: Feys P, Lamers I, Francis G, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. The Nine-Hole Peg Test as a manual dexterity performance measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):711-720. doi: 10.1177/1352458517690824. Epub 2017 Feb 16.
  PMID: 28206826
  citation: Giray E, Akyuz G. Assessment of Family Caregiver Burden and Its Relationships Between Quality of Life, Arm Disability, Grip Strength, and Lymphedema Symptoms in Women with Postmastectomy Lymphedema: A Prospective Cross-Sectional Study. Eur J Breast Health. 2019 Feb 15;15(2):111-118. doi: 10.5152/ejbh.2019.4385. eCollection 2019 Apr.
  PMID: 31001613
  responsible party type: Principal Investigator
  investigator affiliation: Texas Woman's University
  investigator full name: Elisabeth Wise
  investigator title: Primary Investigator, Physical Therapist
  mesh term: Breast Neoplasms
  mesh term: Lymphedema
  mesh term: Breast Cancer Lymphedema
  sharing ipd: No
  ipd description: No plan to share IPD with other researchers.
  provided document: 