<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/NCT03755180</url>
  </required_header>
  <id_info>
    <org_study_id>99984023-302.14.04-</org_study_id>
    <nct_id>NCT03755180</nct_id>
  </id_info>
  <brief_title>Exercise Training in Venous Insufficiency</brief_title>
  <official_title>The Effectiveness of Exercise Training in Venous Insufficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University - Cerrahpasa (IUC)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University - Cerrahpasa (IUC)</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 aim of this study is to evaluate the effects of exercise training in addition to&#xD;
      compression therapy on clinical severity, vein diameter, reflux and quality of life in venous&#xD;
      insufficiency patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Volunteers who have been diagnosed with venous insufficiency according to the criteria of&#xD;
      inclusion, who applied to Istanbul University Istanbul Medical Faculty Cardiovascular Surgery&#xD;
      Department will be included this study.&#xD;
&#xD;
      Participants will be randomly allocated 2 groups using the 'Research Randomizer' website. In&#xD;
      both groups, a common evaluation protocol will be applied to the patients.&#xD;
&#xD;
      Exercise training in addition to compression bandages will be applied to first group,&#xD;
      compression bandages will be applied to second group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2018</start_date>
  <completion_date type="Actual">June 17, 2019</completion_date>
  <primary_completion_date type="Actual">June 17, 2019</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20</measure>
    <time_frame>Change from Baseline Quality of Life at 6 weeks.</time_frame>
    <description>CIVIQ 20 is a disease-related quality of life assessment form especially for chronic venous insufficiency patients. The total score is at least 0 and at most 100, and the higher scores indicate better quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duplex Ultrasonography</measure>
    <time_frame>Duplex Ultrasonography results is evaluated at baseline and six weeks rehabilitation program.</time_frame>
    <description>Duplex Ultrasonography is a form of ultrasound that produces images that differentiate between the body's soft tissues and its fluid-filled structures. Duplex Ultrasonography provides information on vascular diameter and reflux in chronic venous insufficiency patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Venous Clinical Severity Score (VCSS)</measure>
    <time_frame>Assessment is performed at baseline and six weeks rehabilitation program.</time_frame>
    <description>The VCSS was subsequently developed as an evaluative instrument that would be responsive to changes in disease severity over time and in response to treatment.The total score is at least 0 and at most 30, and the low scores are positively correlated with the severe clinical condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>Assessment is performed at baseline and six weeks rehabilitation program.</time_frame>
    <description>The levels of pain felt rest/activity/night will be measured using visual analogue scale (VAS). Patients will be asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The 6 Minute Walk Test</measure>
    <time_frame>Assessment is performed at baseline and six weeks rehabilitation program.</time_frame>
    <description>The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>10-Meter Walk Test</measure>
    <time_frame>Assessment is performed at baseline and six weeks rehabilitation program.</time_frame>
    <description>The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Muscle Strength with Handheld Dynamometer</measure>
    <time_frame>Assessment is performed at baseline and six weeks rehabilitation program.</time_frame>
    <description>The muscle strength of the gastrocnemius and tibialis anterior muscles will be evaluated using the handheld dynamometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form 36 (SF-36)</measure>
    <time_frame>Assessment is performed before treatment and after six weeks rehabilitation program.</time_frame>
    <description>SF-36 is used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with the high quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of Calf Girth</measure>
    <time_frame>Assessment is performed at baseline and six weeks rehabilitation program.</time_frame>
    <description>Circumference measurements will be recorded at 10 cm intervals of both lower legs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Venous Insufficiency</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise Group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Compression Group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise Training</intervention_name>
    <description>In exercise training, aerobic exercise and strengthening exercises, especially for gastrocnemius and tibialis anterior muscles, will be applied to the patients. In addition the exercise training, Compression Therapy is applied to patients.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Compression Therapy</intervention_name>
    <description>Compression therapy is a treatment applied to patients in the form of Four Layer Compression Bandage and Compression Stocking. Four Layer Compression Bandage is a treatment that requires four different types of bandages. The compression stocking is an elastic stock with various tension and length.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of venous insufficiency with duplex ultrasonography&#xD;
&#xD;
          -  Classification of CEAP (Clinical-Etiological-Anatomical-Pathological) used in venous&#xD;
             insufficiency is C3-C4-C5-C6&#xD;
&#xD;
          -  Ankle-brachial index (ABI) is less than 0.7&#xD;
&#xD;
          -  Possibility to communicate in written and verbal in Turkish&#xD;
&#xD;
          -  Have a level of cognitive ability to understand the instructions given&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of deep vein thrombosis&#xD;
&#xD;
          -  Ulceration or open burn wound in lower extremity greater than 4 cm&#xD;
&#xD;
          -  Presence of infected ulceration&#xD;
&#xD;
          -  Cardiorespiratory insufficiency&#xD;
&#xD;
          -  Orthopedic, rheumatologic or neurological comorbidities restrain the exercise in lower&#xD;
             extremity&#xD;
&#xD;
          -  Presence of a psychiatric illness requiring the use of prescribed medicines&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saliha Gürdal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul University Health Sciences Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>İpek Yeldan</last_name>
    <role>Study Director</role>
    <affiliation>Istanbul University Faculty of Health Science</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Faculty of Medicine</name>
      <address>
        <city>Istanbul</city>
        <state>Fatih</state>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>December 29, 2020</last_update_submitted>
  <last_update_submitted_qc>December 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
    <investigator_full_name>Saliha Gürdal Karakelle</investigator_full_name>
    <investigator_title>Research Assisstant</investigator_title>
  </responsible_party>
  <keyword>Venous Insufficiency</keyword>
  <keyword>Exercise</keyword>
  <keyword>Compression Bandages</keyword>
  <keyword>Duplex Doppler Ultrasonography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venous Insufficiency</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/NCT03755180
org study id: 99984023-302.14.04-
nct id: NCT03755180
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the effects of exercise training in addition to
      compression therapy on clinical severity, vein diameter, reflux and quality of life in venous
      insufficiency patients.
Volunteers who have been diagnosed with venous insufficiency according to the criteria of
      inclusion, who applied to Istanbul University Istanbul Medical Faculty Cardiovascular Surgery
      Department will be included this study.

      Participants will be randomly allocated 2 groups using the 'Research Randomizer' website. In
      both groups, a common evaluation protocol will be applied to the patients.

      Exercise training in addition to compression bandages will be applied to first group,
      compression bandages will be applied to second group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20
time frame: Change from Baseline Quality of Life at 6 weeks.
description: CIVIQ 20 is a disease-related quality of life assessment form especially for chronic venous insufficiency patients. The total score is at least 0 and at most 100, and the higher scores indicate better quality of life.
measure: Duplex Ultrasonography
time frame: Duplex Ultrasonography results is evaluated at baseline and six weeks rehabilitation program.
description: Duplex Ultrasonography is a form of ultrasound that produces images that differentiate between the body's soft tissues and its fluid-filled structures. Duplex Ultrasonography provides information on vascular diameter and reflux in chronic venous insufficiency patients.
measure: Venous Clinical Severity Score (VCSS)
time frame: Assessment is performed at baseline and six weeks rehabilitation program.
description: The VCSS was subsequently developed as an evaluative instrument that would be responsive to changes in disease severity over time and in response to treatment.The total score is at least 0 and at most 30, and the low scores are positively correlated with the severe clinical condition.
measure: Visual Analogue Scale (VAS)
time frame: Assessment is performed at baseline and six weeks rehabilitation program.
description: The levels of pain felt rest/activity/night will be measured using visual analogue scale (VAS). Patients will be asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.
measure: The 6 Minute Walk Test
time frame: Assessment is performed at baseline and six weeks rehabilitation program.
description: The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
measure: 10-Meter Walk Test
time frame: Assessment is performed at baseline and six weeks rehabilitation program.
description: The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance.
measure: Assessment of Muscle Strength with Handheld Dynamometer
time frame: Assessment is performed at baseline and six weeks rehabilitation program.
description: The muscle strength of the gastrocnemius and tibialis anterior muscles will be evaluated using the handheld dynamometer.
measure: Short Form 36 (SF-36)
time frame: Assessment is performed before treatment and after six weeks rehabilitation program.
description: SF-36 is used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with the high quality of life.
measure: Measurement of Calf Girth
time frame: Assessment is performed at baseline and six weeks rehabilitation program.
description: Circumference measurements will be recorded at 10 cm intervals of both lower legs.
arm group label: Group 1
arm group type: Experimental
description: Exercise Group
arm group label: Group 2
arm group type: Active Comparator
description: Compression Group
intervention type: Other
intervention name: Exercise Training
description: In exercise training, aerobic exercise and strengthening exercises, especially for gastrocnemius and tibialis anterior muscles, will be applied to the patients. In addition the exercise training, Compression Therapy is applied to patients.
arm group label: Group 1
intervention type: Other
intervention name: Compression Therapy
description: Compression therapy is a treatment applied to patients in the form of Four Layer Compression Bandage and Compression Stocking. Four Layer Compression Bandage is a treatment that requires four different types of bandages. The compression stocking is an elastic stock with various tension and length.
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Saliha Gürdal
role: Principal Investigator
affiliation: Istanbul University Health Sciences Institute
last name: İpek Yeldan
role: Study Director
affiliation: Istanbul University Faculty of Health Science
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University - Cerrahpasa (IUC)
investigator full name: Saliha Gürdal Karakelle
investigator title: Research Assisstant
mesh term: Venous Insufficiency
sharing ipd: No