<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/NCT04421807</url>
  </required_header>
  <id_info>
    <org_study_id>2020/05/29</org_study_id>
    <nct_id>NCT04421807</nct_id>
  </id_info>
  <brief_title>Effects of Scapulathoracic Stabilization Exercises Plus Complex Decongestive Therapy in Women With Lymphedema</brief_title>
  <official_title>Investigation of the Effects of Scapulathoracic Stabilization Exercises Additionally Applied to Complex Decongestive Therapy After Mastectomy on Posture, Balance and Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ataturk Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ataturk Training and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to investigate the effects of scapulathoracic stabilization exercises&#xD;
      additionally applied to complex decongestive therapy after mastectomy on posture, balance and&#xD;
      quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lymphedema is a chronic and progressive condition that occurs with the accumulation of&#xD;
      protein-rich fluid in interstitial tissue spaces as a result of abnormal development or&#xD;
      damage to the lymphatic system. Lymphedema is divided into 2 as primary and secondary.&#xD;
      Secondary lymphedema is the most common form seen in upper extremity, usually after breast&#xD;
      cancer treatment approaches. In lymphedema, not only upper limb affected, but also posture,&#xD;
      balance, shoulder girdle, scapula and quality of life can be adversely affected. Complex&#xD;
      decongestive therapy has been accepted as the gold standard treatment in lymphedema to reduce&#xD;
      edema, however, there were insufficient studies investigating the effects on the posture and&#xD;
      the balance in patients with lymphedema. Scapulatoracic stabilization exercises aim to&#xD;
      increase muscle stability ability, kinesthetic awareness, ovarall stability and balance.&#xD;
      However, when the literature is reviewed, no study is found investigating the effect of&#xD;
      scapulatoracic stabilization exercises in individuals who developed lymphedema after&#xD;
      mastectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">January 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thoracic khyphosis</measure>
    <time_frame>change from baseline , at 4 weeks and at 8 weeks</time_frame>
    <description>Thoracic Kyphosis will be evaluated with digital inclinometer device (Baseline® Digital İnclinometer).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Posture angle</measure>
    <time_frame>change from baseline , at 4 weeks and at 8 weeks</time_frame>
    <description>Posture angle will be evaluated with the PostureScreen Mobile (HuaweiTechnologies Co. Ltd, FIG-LX1, Android) application installed on a smartphone</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General posture status</measure>
    <time_frame>change from baseline , at 4 weeks and at 8 weeks</time_frame>
    <description>General posture status will be evaluated with the New York Posture Scale, postural changes that can occur in 13 different parts of the body are scored by observing the individual posteriorly and laterally. Each parameter is given 5 if smooth, 3 if moderately impaired, 1 if severely impaired. At the end of the scoring minimum 13, maximum 65 points can be obtained.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>change from baseline , at 4 weeks and at 8 weeks</time_frame>
    <description>Balance will be evaluated with MINIBESTEST. It includes sub-parameters of Intuitive, Reactive Postural Control, Sensory Orientation, Dynamic Walk. Each parameter has its own scoring and the total score is obtained by adding all of them. In the test consisting of 14 items, each parameter is given a score between 0-2. 0 indicates the lowest function level, 2 indicates the highest function level. A maximum of 28 points is obtained at the end of the scoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life outcomes</measure>
    <time_frame>change from baseline , at 4 weeks and at 8 weeks</time_frame>
    <description>It will be evaluated with Lymphedema Quality of Life Questionnaire. The survey consists of 21 questions. The first part of the 20 questions contains the questions of function, appearance, symptom and mood, and the last question evaluates the overall quality of life. The first 20 questions area scoring is not at all (1), a little (2), quite (3), many (4). The total score ranges from &quot;1&quot; to &quot;4&quot; and is obtained by dividing the sum of the question scores answered by the number of questions. A high score indicates that the quality of life is low. The last question that assesses the overall health status is between 0 (bad) and 10 (excellent).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The severity of the lymphoedema</measure>
    <time_frame>change from baseline , at 4 weeks and at 8 weeks</time_frame>
    <description>For the evaluation of the severity of the lymphoedema, circumferential measurements in centimeters on bilateral upper extremities. at 5-cm intervals from wrist to axilla will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lymphedema symptoms</measure>
    <time_frame>change from baseline , at 4 weeks and at 8 weeks</time_frame>
    <description>Pain, numbness, tingling, fatigue, feeling of heaviness in lymphedema symptoms were evaluated individually with Visual Analogue Scale. This scale is a 10 cm line with no marks along them, anchored with thewords&quot;no pain&quot;on one hand, and&quot;the most severe pain&quot;on theother. Participants will be simply instructed to place a mark alongthe line at a level representing the intensity of their pain,Pain, numbness, tingling, fatigue, feeling of heaviness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion of shoulder</measure>
    <time_frame>change from baseline , at 4 weeks and at 8 weeks</time_frame>
    <description>Range of motion will be evaluated with Baseline Universal Goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scapulatoracic muscle strength</measure>
    <time_frame>change from baseline , at 4 weeks and at 8 weeks</time_frame>
    <description>It was evaluated with digital hand-held dynamometer (Commander Echo Manual Muscle Testing Device by JTECH) for upper, middle and lower trapezius muscle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scapular dyskinesia</measure>
    <time_frame>change from baseline , at 4 weeks and at 8 weeks</time_frame>
    <description>It will be evaluated with Lateral Scapular Slide Test, Wall Push Up Test and Scapular Isometrik Pinch Test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper extremity functions</measure>
    <time_frame>change from baseline , at 4 weeks and at 8 weeks</time_frame>
    <description>It will be evaluated using Arm Shoulder and Hand Problems Survey.This questionnaire consists of 30 questions. The first 20 questions question physical adequacy, the last 10 questions pain and the functional and environmental constraint associated with it. The total score takes between 0 and 100 points. Higher score means more disability.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Lymphedema</condition>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>Exercise+Complex decongestive therapy (CDT) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Only Complex decongestive therapy (CDT) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Scapulatoracic stabilization exercises</intervention_name>
    <description>Scapulatoracic stabilization exercises consisted of 3 phases; the warming phase which consists of mobility and stretching; exercise phase consisting of static, dynamic and functional phase; the cooling phase consisting of mobility and stretching. Scapulatoracic stabilization exercises additionally applied to CDT were performed 3 days a week for 8 weeks. These exercises were specially planned for the patients and applied gradually</description>
    <arm_group_label>Exercise+Complex decongestive therapy (CDT) group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Complex decongestive therapy (CDT)</intervention_name>
    <description>In the treatment phase of CDT, manual lymph drainage, skin care, compression bandage, draining exercise were applied 5 days a week for 3 weeks. Compression socks, self-drainage, skin care and unloading exercises were applied for 5 weeks in the protection phase of CDT. Thus, patients were followed up with the CDT program for 8 weeks.</description>
    <arm_group_label>Exercise+Complex decongestive therapy (CDT) group</arm_group_label>
    <arm_group_label>Only Complex decongestive therapy (CDT) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 65 years of age&#xD;
&#xD;
          -  Agree to participate in the study,&#xD;
&#xD;
          -  Undergoing unilateral mastectomy due to breast cancer treatment and additionally&#xD;
             development of limb lymphedema,&#xD;
&#xD;
          -  Lymphedema stage 2 and 3,&#xD;
&#xD;
          -  Being a woman,&#xD;
&#xD;
          -  Having spent at least 6 months after the operation&#xD;
&#xD;
          -  With or without radiotherapy and / or chemotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Irregular participation to the treatment program,&#xD;
&#xD;
          -  Severe heart failure and / or rhythm disturbance,&#xD;
&#xD;
          -  Uncontrolled hypertension,&#xD;
&#xD;
          -  Presence of metastasis,&#xD;
&#xD;
          -  Infection in the affected arm,&#xD;
&#xD;
          -  Any problems that may affect balance (rheumatological, vestibular, visual,&#xD;
             neurological),&#xD;
&#xD;
          -  Muscular and skeletal system problems (limb shortness, ankle sprain ...), which may&#xD;
             affect the balance and posture negatively.&#xD;
&#xD;
          -  Presence of spinal deformity,&#xD;
&#xD;
          -  Those who have had spinal surgery in the last 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>women with lymphedema after mastectomy</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seyda TOPRAK CELENAY</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ankara Yildirim Beyazıt University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Seyda TOPRAK CELENAY</last_name>
    <phone>+90-534-041-3986</phone>
    <email>sydtoprak@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ankara Yildirim Beyazit University</name>
      <address>
        <city>Ankara</city>
        <zip>06760</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seyda Toprak Celenay</last_name>
      <email>sydtoprak@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ataturk Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Seyda TOPRAK CELENAY</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Lymphedema</keyword>
  <keyword>decongestive therapy</keyword>
  <keyword>exercise</keyword>
  <keyword>posture</keyword>
  <keyword>balance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphedema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04421807
org study id: 2020/05/29
nct id: NCT04421807
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to investigate the effects of scapulathoracic stabilization exercises
      additionally applied to complex decongestive therapy after mastectomy on posture, balance and
      quality of life.
Lymphedema is a chronic and progressive condition that occurs with the accumulation of
      protein-rich fluid in interstitial tissue spaces as a result of abnormal development or
      damage to the lymphatic system. Lymphedema is divided into 2 as primary and secondary.
      Secondary lymphedema is the most common form seen in upper extremity, usually after breast
      cancer treatment approaches. In lymphedema, not only upper limb affected, but also posture,
      balance, shoulder girdle, scapula and quality of life can be adversely affected. Complex
      decongestive therapy has been accepted as the gold standard treatment in lymphedema to reduce
      edema, however, there were insufficient studies investigating the effects on the posture and
      the balance in patients with lymphedema. Scapulatoracic stabilization exercises aim to
      increase muscle stability ability, kinesthetic awareness, ovarall stability and balance.
      However, when the literature is reviewed, no study is found investigating the effect of
      scapulatoracic stabilization exercises in individuals who developed lymphedema after
      mastectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Thoracic khyphosis
time frame: change from baseline , at 4 weeks and at 8 weeks
description: Thoracic Kyphosis will be evaluated with digital inclinometer device (Baseline® Digital İnclinometer).
measure: Posture angle
time frame: change from baseline , at 4 weeks and at 8 weeks
description: Posture angle will be evaluated with the PostureScreen Mobile (HuaweiTechnologies Co. Ltd, FIG-LX1, Android) application installed on a smartphone
measure: General posture status
time frame: change from baseline , at 4 weeks and at 8 weeks
description: General posture status will be evaluated with the New York Posture Scale, postural changes that can occur in 13 different parts of the body are scored by observing the individual posteriorly and laterally. Each parameter is given 5 if smooth, 3 if moderately impaired, 1 if severely impaired. At the end of the scoring minimum 13, maximum 65 points can be obtained.
measure: Balance
time frame: change from baseline , at 4 weeks and at 8 weeks
description: Balance will be evaluated with MINIBESTEST. It includes sub-parameters of Intuitive, Reactive Postural Control, Sensory Orientation, Dynamic Walk. Each parameter has its own scoring and the total score is obtained by adding all of them. In the test consisting of 14 items, each parameter is given a score between 0-2. 0 indicates the lowest function level, 2 indicates the highest function level. A maximum of 28 points is obtained at the end of the scoring.
measure: Quality of life outcomes
time frame: change from baseline , at 4 weeks and at 8 weeks
description: It will be evaluated with Lymphedema Quality of Life Questionnaire. The survey consists of 21 questions. The first part of the 20 questions contains the questions of function, appearance, symptom and mood, and the last question evaluates the overall quality of life. The first 20 questions area scoring is not at all (1), a little (2), quite (3), many (4). The total score ranges from "1" to "4" and is obtained by dividing the sum of the question scores answered by the number of questions. A high score indicates that the quality of life is low. The last question that assesses the overall health status is between 0 (bad) and 10 (excellent).
measure: The severity of the lymphoedema
time frame: change from baseline , at 4 weeks and at 8 weeks
description: For the evaluation of the severity of the lymphoedema, circumferential measurements in centimeters on bilateral upper extremities. at 5-cm intervals from wrist to axilla will be used
measure: Lymphedema symptoms
time frame: change from baseline , at 4 weeks and at 8 weeks
description: Pain, numbness, tingling, fatigue, feeling of heaviness in lymphedema symptoms were evaluated individually with Visual Analogue Scale. This scale is a 10 cm line with no marks along them, anchored with thewords"no pain"on one hand, and"the most severe pain"on theother. Participants will be simply instructed to place a mark alongthe line at a level representing the intensity of their pain,Pain, numbness, tingling, fatigue, feeling of heaviness.
measure: Range of motion of shoulder
time frame: change from baseline , at 4 weeks and at 8 weeks
description: Range of motion will be evaluated with Baseline Universal Goniometer
measure: Scapulatoracic muscle strength
time frame: change from baseline , at 4 weeks and at 8 weeks
description: It was evaluated with digital hand-held dynamometer (Commander Echo Manual Muscle Testing Device by JTECH) for upper, middle and lower trapezius muscle.
measure: Scapular dyskinesia
time frame: change from baseline , at 4 weeks and at 8 weeks
description: It will be evaluated with Lateral Scapular Slide Test, Wall Push Up Test and Scapular Isometrik Pinch Test.
measure: Upper extremity functions
time frame: change from baseline , at 4 weeks and at 8 weeks
description: It will be evaluated using Arm Shoulder and Hand Problems Survey.This questionnaire consists of 30 questions. The first 20 questions question physical adequacy, the last 10 questions pain and the functional and environmental constraint associated with it. The total score takes between 0 and 100 points. Higher score means more disability.
arm group label: Exercise+Complex decongestive therapy (CDT) group
arm group type: Experimental
description: The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study
arm group label: Only Complex decongestive therapy (CDT) group
arm group type: Active Comparator
description: The patients diagnosed with lymphedema with 18-65years of age followed by routine controls and who were volunteered will be included in the study
intervention type: Other
intervention name: Scapulatoracic stabilization exercises
description: Scapulatoracic stabilization exercises consisted of 3 phases; the warming phase which consists of mobility and stretching; exercise phase consisting of static, dynamic and functional phase; the cooling phase consisting of mobility and stretching. Scapulatoracic stabilization exercises additionally applied to CDT were performed 3 days a week for 8 weeks. These exercises were specially planned for the patients and applied gradually
arm group label: Exercise+Complex decongestive therapy (CDT) group
intervention type: Other
intervention name: Complex decongestive therapy (CDT)
description: In the treatment phase of CDT, manual lymph drainage, skin care, compression bandage, draining exercise were applied 5 days a week for 3 weeks. Compression socks, self-drainage, skin care and unloading exercises were applied for 5 weeks in the protection phase of CDT. Thus, patients were followed up with the CDT program for 8 weeks.
arm group label: Exercise+Complex decongestive therapy (CDT) group
arm group label: Only Complex decongestive therapy (CDT) group
criteria: 
gender: Female
gender based: Yes
gender description: women with lymphedema after mastectomy
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Seyda TOPRAK CELENAY
role: Principal Investigator
affiliation: Ankara Yildirim Beyazıt University
last name: Seyda TOPRAK CELENAY
phone: +90-534-041-3986
email: sydtoprak@hotmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ataturk Training and Research Hospital
investigator full name: Seyda TOPRAK CELENAY
investigator title: Associate Professor
mesh term: Lymphedema
sharing ipd: No