<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/NCT03762044</url>
  </required_header>
  <id_info>
    <org_study_id>Lymphedema Rehabilitation</org_study_id>
    <nct_id>NCT03762044</nct_id>
  </id_info>
  <brief_title>New Therapeutic Approach in Upper Limb Lymphedema Secondary to Breast Cancer: Activity-oriented Proprioceptive Antiedema Therapy (TAPA)</brief_title>
  <official_title>New Therapeutic Approach in Upper Limb Lymphedema Secondary to Breast Cancer: Activity-oriented Proprioceptive Antiedema Therapy (TAPA). A Randomized Controlled Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario Reina Sofia de Cordoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario Reina Sofia de Cordoba</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>
      This study evaluates the effectiveness of an experimental proposal therapy for upper limb&#xD;
      lymphedema secondary to breast called Activity-oriented proprioceptive antiedema therapy&#xD;
      (TAPA) facing the consensual gold standard treatment, the complete decongestive therapy. TAPA&#xD;
      consists in:&#xD;
&#xD;
        -  Health education / patient empowerment.&#xD;
&#xD;
        -  Neurodynamic activities oriented to Activities of Daily Living (ADL).&#xD;
&#xD;
        -  Proprioceptive neuromuscular facilitation exercises oriented to ADL.&#xD;
&#xD;
        -  Self-adherent self-adhesive antiedema of low compression.&#xD;
&#xD;
      Half of patients will receive TAPA treatment while the other half will receive CDT standard&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lymphedema is defined as the abnormal accumulation of tissue proteins, which is accompanied&#xD;
      of edema and chronic inflammation of a limb, so post-mastectomy lymphedema is one of the most&#xD;
      serious sequelae of Breast Cancer (BC) that affects the quality of life of women operated for&#xD;
      breast cancer. Its incidence is approximately between 6 and 30% of patients and its&#xD;
      prevalence varies between 15-20%. It is considered a process without spontaneous resolution&#xD;
      that involves the application of a palliative therapy conservative for life, with preventive&#xD;
      measures to reduce it and prevent complications and an expected increase in the number of&#xD;
      patients with lymphedema in the next years&#xD;
&#xD;
      Changes in work performance resulting from lymphedema vary from minor temporary changes to&#xD;
      significant difficulties in the ADL, depending on the chronicity and severity of the&#xD;
      affectation. It could affect physical components and psychological, as well as social and&#xD;
      economic environment. In these limitations on activities and / or restrictions of&#xD;
      participation, the Occupational Therapists (OT) provide a unique approach, since they are&#xD;
      professionals specifically enabled for the use of the therapeutic potential of the activity&#xD;
      and graduation of its control parameters in favor of the best occupational performance&#xD;
      possible of the person. Furthermore, there are some research that support the inclusion of OT&#xD;
      in the cancer rehabilitation and reveal a significant need for more research to explore ways&#xD;
      in which the OT favorably influences the results of the cancer survivors.&#xD;
&#xD;
      The anamnesis, clinical exploration and complementary studies if necessary, allow us confirm&#xD;
      the diagnosis of lymphedema, stage, possibilities of progression and approach the most&#xD;
      indicated therapeutic in each case.&#xD;
&#xD;
      The conservative therapeutic of upper limb lymphoedema secondary to breast cancer plan&#xD;
      includes preventive exercises and lifestyle habits, complete decongestive therapy (CDT) and&#xD;
      compression garments.&#xD;
&#xD;
      The CDT comprises a series of measures, a first intensive phase consists of:&#xD;
&#xD;
        -  Skin care.&#xD;
&#xD;
        -  Kinesitherapy&#xD;
&#xD;
        -  Manual lymphatic drainage (MLD)&#xD;
&#xD;
        -  Multilayer bandage. The maintenance phase is based on self-care and the use of&#xD;
           compression garments.&#xD;
&#xD;
      Despite the consensus of the experts in the evidence of decongestive therapy in lymphedema,&#xD;
      there is still a lack of evidence to inform the optimal doses of treatment and the level of&#xD;
      evidence about its efficacy in the treatment of lymphedema is only moderately strong, due to&#xD;
      the scarcity of randomized trials with control group, well interventions controlled, accurate&#xD;
      measures of volume, mobility or function and quality of life.&#xD;
&#xD;
      Likewise, the prescription of compression garments for lymphoedema is very varied and it may&#xD;
      be due to the lack of underlying evidence to inform about the treatment. The evidence also&#xD;
      suggests that the comprehensiveness and effectiveness of rehabilitation post-operative BC&#xD;
      should also consider the self-control (empowerment) of patients, approaches to redesign the&#xD;
      lifestyle and incorporate aspects of the promotion of health.&#xD;
&#xD;
      On the other hand, there are studies that confirm that women with lymphedema and pain after&#xD;
      BC may present alterations in neural mechanosensitivity, neuropathic pain, as a result of&#xD;
      nerve compression or peripheral neuropathy induced by chemotherapy and that it is worth&#xD;
      conducting a clinical trial to evaluate the techniques of Neural mobilization (NM) oriented&#xD;
      to the functionality of upper extremities, supporting the clinical mechanism of NM in the&#xD;
      reduction of intraneural edema.&#xD;
&#xD;
      Published research suggests incorporating proprioceptive neuromuscular facilitation (PNF)&#xD;
      with the traditional NM method, to facilitate the process of treatment for patients with&#xD;
      lymphoedema, because it induces powerful synergistic effects on the volume of edema, range of&#xD;
      motion (ROM) of the shoulder, pain and depression. That treatment independently or in&#xD;
      combination with laser also improves these variables and even the speed of blood circulation&#xD;
      in the armpit. Furthermore, in a study in which bandaging could not be used and CDT was&#xD;
      combined with PNF and respiration, reducing lymphedema and improving ROM too, which could&#xD;
      improve performance of activities, level of participation and, therefore, quality of life.&#xD;
&#xD;
      There are research supporting use of Coban®3M bandage as early start of pressotherapy in the&#xD;
      rehabilitation treatment of lymphedema to reduce prolonged edema (agent cause of multiple&#xD;
      complications and functional loss), we consider the possibility of testing the efficacy of a&#xD;
      bandage with similar characteristics, in terms of elasticity and self-adherence, more&#xD;
      economical, applying it from distal to proximal, with a low level of compression, in order to&#xD;
      provide proprioceptive information, but avoiding compressive syndrome, reducing pain and&#xD;
      edema and improving the performance of ADL through the practice of them. It consists in only&#xD;
      two thin layers and it is fast (10 minutes) and simple placement (can be self-administered by&#xD;
      the patient and / or caregiver), improving cost- effectiveness of treatments combined with&#xD;
      three other techniques whose evidence has been previously reviewed. We have agreed to call&#xD;
      this therapy we propose in this study Activity-oriented Proprioceptive Antiedema Therapy&#xD;
      (TAPA in Spanish):&#xD;
&#xD;
        -  Health education / patient empowerment.&#xD;
&#xD;
        -  Neurodynamic activities oriented to ADL.&#xD;
&#xD;
        -  Proprioceptive neuromuscular facilitation exercises oriented to ADL.&#xD;
&#xD;
        -  Self-adherent self-adhesive antiedema of low compression.&#xD;
&#xD;
      Given the consensus of the CDT as a gold standard treatment in lymphedema, we consider that&#xD;
      our experimental treatment TAPA should make the comparison with it. So, half of patients will&#xD;
      receive TAPA treatment while the other half will receive CDT standard treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 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>
    <intervention_model_description>After proposing to the subjects the enrollment to the study and once they accept, they will be randomly allocated to experimental TAPA treatment group or standard CDT treatment. They will be assessed 1 to 3 days before and after completing the treatment. It will be consists in a total of 10 sessions of 30 minutes of treatment, twice per week in a total 5 weeks period.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>In order to masking, investigator who assess the subject before and after the treatment will not know which group the subjects belong, and so the biostatistician.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Volume</measure>
    <time_frame>Baseline and 5 weeks</time_frame>
    <description>Volume of the upper limb lymphedema using the Kuhnke formula (Vol=(C1^2+C2^2+...Cn^2)/π). It allows you to assess the volume difference between the affected limb and the healthy one. According to the Working Group of the XI International Lymphology Congress, lymphedema are classified in grade I (mild) ( 10-25% difference), grade II (moderate) (26-50% difference) and grade III (severe) (&gt;51% difference).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circometry</measure>
    <time_frame>Baseline and 5 weeks</time_frame>
    <description>Perimeter of upper limb lymphedema using a measuring tape in seven spots: Metacarpophalangeal, 5 and 10cm over radial styloid, 5cm under lateral epicondyle and 5, 10 and 15cm over lateral epicondyle. It is significative when there is a 2cm difference between the healthy and affected limb.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH)</measure>
    <time_frame>Baseline and 5 weeks</time_frame>
    <description>Upper limp function for development of activities using the Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH), which consists in eleven questions. 10 out of 11 eleven questions must be answered. All the answers are added and divided by the number of questions answered. Then, subtract 1 and multiply by 25. The higher the score, the greater the disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper Limb Lymphedema 27 (ULL-27)</measure>
    <time_frame>Baseline and 5 weeks</time_frame>
    <description>Quality of life in a questionnaire specific to patients with upper limb lymphedema secondary to breast cancer called Upper Limb Lymphedema 27 (ULL-27). The ULL-27 is a self-report questionnaire encompassing 27 questions with answers given on a 5-point Likert scale, ranging from &quot;never&quot; to &quot;always&quot; and is considered to measure the effects of lymphedema on health related quality of life. The questionnaire measures three domains: physical (15 items), psychological (7 items) and social (5 items), with scores ranging from 0 to 100 (100 being the best score possible).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Breast Cancer Lymphedema</condition>
  <condition>Post-Mastectomy Secondary Lymphedema</condition>
  <arm_group>
    <arm_group_label>Activity-oriented Proprioceptive Antiedema Therapy (TAPA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 sessions of 30 minutes, twice a week in a total 5 week period of Activity-oriented Proprioceptive Antiedema Therapy (TAPA in Spanish)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Complete Decongestive Therapy (CDT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 sessions of 30 minutes, twice a week in a total 5 week period of complete decongestive therapy (CDT).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Activity-oriented Proprioceptive Antiedema Therapy (TAPA)</intervention_name>
    <description>Health education / patient empowerment.&#xD;
Neurodynamic activities oriented to ADL.&#xD;
Proprioceptive neuromuscular facilitation exercises oriented to ADL.&#xD;
Self-adherent self-adhesive antiedema of low compression.</description>
    <arm_group_label>Activity-oriented Proprioceptive Antiedema Therapy (TAPA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Complete Decongestive Therapy (CDT)</intervention_name>
    <description>Skin care.&#xD;
Kinesitherapy&#xD;
Manual lymphatic drainage (MLD)&#xD;
Multilayer bandage.&#xD;
The maintenance phase is based on self-care and the use of compression garments.</description>
    <arm_group_label>Complete Decongestive Therapy (CDT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Upper limb lymphedema secondary to breast cancer grade I and II, according to the&#xD;
             Working Group of the XI International Lymphology Congress&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Upper limb lymphedema secondary to breast cancer grade 0 and III, according to the&#xD;
             Working Group of the XI International Lymphology Congress&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>It consists in women with upper limb lymphedema secondary to breast cancer</gender_description>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>María N Muñoz Alcaraz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Distrito Sanitario Córdoba Guadalquivir. Servicio Andaluz de Salud.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>María V Olmo Carmona</last_name>
    <role>Principal Investigator</role>
    <affiliation>UGC de Medicina Física y Rehabilitación IN. Hospital Universitario Reina Sofía</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antonio J Jiménez Vílchez</last_name>
    <role>Principal Investigator</role>
    <affiliation>UGC de Medicina Física y Rehabilitación IN. Hospital Universitario Reina Sofía</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luis A Pérula de Torres</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unidad Docente de Medicina Familiar y Comunitaria de Córdoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jesús Serrano Merino</last_name>
    <role>Principal Investigator</role>
    <affiliation>Distrito Sanitario Córdoba Guadalquivir. Servicio Andaluz de Salud.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antonio J Jiménez Vílchez</last_name>
    <phone>957010122</phone>
    <email>antonioj.jimenez.vilchez.sspa@juntadeandalucia.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>María N Muñoz Alcaraz</last_name>
    <email>marian.munoz.sspa@juntadeandalucia.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centro Periférico de Especialidades Castilla del Pino</name>
      <address>
        <city>Córdoba</city>
        <zip>14011</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>María V Olmo Carmona</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario Reina Sofia de Cordoba</investigator_affiliation>
    <investigator_full_name>Antonio José Jiménez Vílchez</investigator_full_name>
    <investigator_title>Physical Medicine &amp; Rehabilitation Hospital Resident</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Breast Cancer Lymphedema</keyword>
  <keyword>Post-Mastectomy Secondary Lymphedema</keyword>
  <keyword>Occupational Therapy</keyword>
  <keyword>Proprioceptive Neuromuscular Facilitation</keyword>
  <keyword>Neural Mobilization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Lymphedema</mesh_term>
    <mesh_term>Breast Cancer Lymphedema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We are still developing the documents, we haven't decided yet if we are going to share them</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03762044
org study id: Lymphedema Rehabilitation
nct id: NCT03762044
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effectiveness of an experimental proposal therapy for upper limb
      lymphedema secondary to breast called Activity-oriented proprioceptive antiedema therapy
      (TAPA) facing the consensual gold standard treatment, the complete decongestive therapy. TAPA
      consists in:

        -  Health education / patient empowerment.

        -  Neurodynamic activities oriented to Activities of Daily Living (ADL).

        -  Proprioceptive neuromuscular facilitation exercises oriented to ADL.

        -  Self-adherent self-adhesive antiedema of low compression.

      Half of patients will receive TAPA treatment while the other half will receive CDT standard
      treatment.
Lymphedema is defined as the abnormal accumulation of tissue proteins, which is accompanied
      of edema and chronic inflammation of a limb, so post-mastectomy lymphedema is one of the most
      serious sequelae of Breast Cancer (BC) that affects the quality of life of women operated for
      breast cancer. Its incidence is approximately between 6 and 30% of patients and its
      prevalence varies between 15-20%. It is considered a process without spontaneous resolution
      that involves the application of a palliative therapy conservative for life, with preventive
      measures to reduce it and prevent complications and an expected increase in the number of
      patients with lymphedema in the next years

      Changes in work performance resulting from lymphedema vary from minor temporary changes to
      significant difficulties in the ADL, depending on the chronicity and severity of the
      affectation. It could affect physical components and psychological, as well as social and
      economic environment. In these limitations on activities and / or restrictions of
      participation, the Occupational Therapists (OT) provide a unique approach, since they are
      professionals specifically enabled for the use of the therapeutic potential of the activity
      and graduation of its control parameters in favor of the best occupational performance
      possible of the person. Furthermore, there are some research that support the inclusion of OT
      in the cancer rehabilitation and reveal a significant need for more research to explore ways
      in which the OT favorably influences the results of the cancer survivors.

      The anamnesis, clinical exploration and complementary studies if necessary, allow us confirm
      the diagnosis of lymphedema, stage, possibilities of progression and approach the most
      indicated therapeutic in each case.

      The conservative therapeutic of upper limb lymphoedema secondary to breast cancer plan
      includes preventive exercises and lifestyle habits, complete decongestive therapy (CDT) and
      compression garments.

      The CDT comprises a series of measures, a first intensive phase consists of:

        -  Skin care.

        -  Kinesitherapy

        -  Manual lymphatic drainage (MLD)

        -  Multilayer bandage. The maintenance phase is based on self-care and the use of
           compression garments.

      Despite the consensus of the experts in the evidence of decongestive therapy in lymphedema,
      there is still a lack of evidence to inform the optimal doses of treatment and the level of
      evidence about its efficacy in the treatment of lymphedema is only moderately strong, due to
      the scarcity of randomized trials with control group, well interventions controlled, accurate
      measures of volume, mobility or function and quality of life.

      Likewise, the prescription of compression garments for lymphoedema is very varied and it may
      be due to the lack of underlying evidence to inform about the treatment. The evidence also
      suggests that the comprehensiveness and effectiveness of rehabilitation post-operative BC
      should also consider the self-control (empowerment) of patients, approaches to redesign the
      lifestyle and incorporate aspects of the promotion of health.

      On the other hand, there are studies that confirm that women with lymphedema and pain after
      BC may present alterations in neural mechanosensitivity, neuropathic pain, as a result of
      nerve compression or peripheral neuropathy induced by chemotherapy and that it is worth
      conducting a clinical trial to evaluate the techniques of Neural mobilization (NM) oriented
      to the functionality of upper extremities, supporting the clinical mechanism of NM in the
      reduction of intraneural edema.

      Published research suggests incorporating proprioceptive neuromuscular facilitation (PNF)
      with the traditional NM method, to facilitate the process of treatment for patients with
      lymphoedema, because it induces powerful synergistic effects on the volume of edema, range of
      motion (ROM) of the shoulder, pain and depression. That treatment independently or in
      combination with laser also improves these variables and even the speed of blood circulation
      in the armpit. Furthermore, in a study in which bandaging could not be used and CDT was
      combined with PNF and respiration, reducing lymphedema and improving ROM too, which could
      improve performance of activities, level of participation and, therefore, quality of life.

      There are research supporting use of Coban®3M bandage as early start of pressotherapy in the
      rehabilitation treatment of lymphedema to reduce prolonged edema (agent cause of multiple
      complications and functional loss), we consider the possibility of testing the efficacy of a
      bandage with similar characteristics, in terms of elasticity and self-adherence, more
      economical, applying it from distal to proximal, with a low level of compression, in order to
      provide proprioceptive information, but avoiding compressive syndrome, reducing pain and
      edema and improving the performance of ADL through the practice of them. It consists in only
      two thin layers and it is fast (10 minutes) and simple placement (can be self-administered by
      the patient and / or caregiver), improving cost- effectiveness of treatments combined with
      three other techniques whose evidence has been previously reviewed. We have agreed to call
      this therapy we propose in this study Activity-oriented Proprioceptive Antiedema Therapy
      (TAPA in Spanish):

        -  Health education / patient empowerment.

        -  Neurodynamic activities oriented to ADL.

        -  Proprioceptive neuromuscular facilitation exercises oriented to ADL.

        -  Self-adherent self-adhesive antiedema of low compression.

      Given the consensus of the CDT as a gold standard treatment in lymphedema, we consider that
      our experimental treatment TAPA should make the comparison with it. So, half of patients will
      receive TAPA treatment while the other half will receive CDT standard treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: After proposing to the subjects the enrollment to the study and once they accept, they will be randomly allocated to experimental TAPA treatment group or standard CDT treatment. They will be assessed 1 to 3 days before and after completing the treatment. It will be consists in a total of 10 sessions of 30 minutes of treatment, twice per week in a total 5 weeks period.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: In order to masking, investigator who assess the subject before and after the treatment will not know which group the subjects belong, and so the biostatistician.
measure: Volume
time frame: Baseline and 5 weeks
description: Volume of the upper limb lymphedema using the Kuhnke formula (Vol=(C1^2+C2^2+...Cn^2)/π). It allows you to assess the volume difference between the affected limb and the healthy one. According to the Working Group of the XI International Lymphology Congress, lymphedema are classified in grade I (mild) ( 10-25% difference), grade II (moderate) (26-50% difference) and grade III (severe) (>51% difference).
measure: Circometry
time frame: Baseline and 5 weeks
description: Perimeter of upper limb lymphedema using a measuring tape in seven spots: Metacarpophalangeal, 5 and 10cm over radial styloid, 5cm under lateral epicondyle and 5, 10 and 15cm over lateral epicondyle. It is significative when there is a 2cm difference between the healthy and affected limb.
measure: Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH)
time frame: Baseline and 5 weeks
description: Upper limp function for development of activities using the Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH), which consists in eleven questions. 10 out of 11 eleven questions must be answered. All the answers are added and divided by the number of questions answered. Then, subtract 1 and multiply by 25. The higher the score, the greater the disability.
measure: Upper Limb Lymphedema 27 (ULL-27)
time frame: Baseline and 5 weeks
description: Quality of life in a questionnaire specific to patients with upper limb lymphedema secondary to breast cancer called Upper Limb Lymphedema 27 (ULL-27). The ULL-27 is a self-report questionnaire encompassing 27 questions with answers given on a 5-point Likert scale, ranging from "never" to "always" and is considered to measure the effects of lymphedema on health related quality of life. The questionnaire measures three domains: physical (15 items), psychological (7 items) and social (5 items), with scores ranging from 0 to 100 (100 being the best score possible).
arm group label: Activity-oriented Proprioceptive Antiedema Therapy (TAPA)
arm group type: Experimental
description: 10 sessions of 30 minutes, twice a week in a total 5 week period of Activity-oriented Proprioceptive Antiedema Therapy (TAPA in Spanish)
arm group label: Complete Decongestive Therapy (CDT)
arm group type: Active Comparator
description: 10 sessions of 30 minutes, twice a week in a total 5 week period of complete decongestive therapy (CDT).
intervention type: Other
intervention name: Activity-oriented Proprioceptive Antiedema Therapy (TAPA)
description: Health education / patient empowerment.
Neurodynamic activities oriented to ADL.
Proprioceptive neuromuscular facilitation exercises oriented to ADL.
Self-adherent self-adhesive antiedema of low compression.
arm group label: Activity-oriented Proprioceptive Antiedema Therapy (TAPA)
intervention type: Other
intervention name: Complete Decongestive Therapy (CDT)
description: Skin care.
Kinesitherapy
Manual lymphatic drainage (MLD)
Multilayer bandage.
The maintenance phase is based on self-care and the use of compression garments.
arm group label: Complete Decongestive Therapy (CDT)
criteria: 
gender: Female
gender based: Yes
gender description: It consists in women with upper limb lymphedema secondary to breast cancer
minimum age: 14 Years
maximum age: 70 Years
healthy volunteers: No
last name: María N Muñoz Alcaraz
role: Principal Investigator
affiliation: Distrito Sanitario Córdoba Guadalquivir. Servicio Andaluz de Salud.
last name: María V Olmo Carmona
role: Principal Investigator
affiliation: UGC de Medicina Física y Rehabilitación IN. Hospital Universitario Reina Sofía
last name: Antonio J Jiménez Vílchez
role: Principal Investigator
affiliation: UGC de Medicina Física y Rehabilitación IN. Hospital Universitario Reina Sofía
last name: Luis A Pérula de Torres
role: Principal Investigator
affiliation: Unidad Docente de Medicina Familiar y Comunitaria de Córdoba
last name: Jesús Serrano Merino
role: Principal Investigator
affiliation: Distrito Sanitario Córdoba Guadalquivir. Servicio Andaluz de Salud.
last name: Antonio J Jiménez Vílchez
phone: 957010122
email: antonioj.jimenez.vilchez.sspa@juntadeandalucia.es
last name: María N Muñoz Alcaraz
email: marian.munoz.sspa@juntadeandalucia.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario Reina Sofia de Cordoba
investigator full name: Antonio José Jiménez Vílchez
investigator title: Physical Medicine & Rehabilitation Hospital Resident
mesh term: Breast Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Lymphedema
mesh term: Breast Cancer Lymphedema
sharing ipd: Undecided
ipd description: We are still developing the documents, we haven't decided yet if we are going to share them