<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/NCT03300622</url>
  </required_header>
  <id_info>
    <org_study_id>DF0070UG</org_study_id>
    <nct_id>NCT03300622</nct_id>
  </id_info>
  <brief_title>Assessment in Patients After Thoracic Surgery</brief_title>
  <official_title>Evaluation of Hospitalized Patients After Thoracic Pulmonary Resection Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Granada</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>
      Lung cancer is the leading cause of death in men and the second in women with a 5 year&#xD;
      survival in Europe of less than 15%. One of the methods most used for its treatment is&#xD;
      pulmonary resection. The objective of this study is to analyze the clinical profile presented&#xD;
      to patients after pulmonary resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One of the most widely used methods for the treatment of lung cancer is pulmonary resection.&#xD;
      The morbidity and mortality of pulmonary resection surgery is conditioned by both the type of&#xD;
      intervention and the patient's condition. Functional deterioration is a risk associated with&#xD;
      hospitalization in the elderly, with a high prevalence (35-70%) and serious consequences,&#xD;
      since in the majority it can lead to the appearance of complications not related to the&#xD;
      reason for admission or the specific treatment. It is very important to evaluate the clinical&#xD;
      profile of patients after pulmonary resection in order to stablish a more specific&#xD;
      repercussion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Strength in upper and lower limbs</measure>
    <time_frame>Baseline, up to 1 month</time_frame>
    <description>Changes from baseline to postintervention during hospital stay in lower and upper limbs strength. The quadriceps and the hand-grip strength is assessed using a portable dynamometer with a standard protocol allowing three attempts on each side.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exercise capacity</measure>
    <time_frame>Baseline, up to 1 month</time_frame>
    <description>Five times sit to stand test (5STS) will be used to assess exercise capacity. 5STS is a simple assessment tool that is feasible in all healthcare settings and involves asking the patient to stand up 5 times for the shortest possible time without arm support.. Saturation and heart rate will be monitored as well as levels of dyspnea and fatigue of the patient.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mood</measure>
    <time_frame>Baseline, up to 1 month</time_frame>
    <description>Mood in these patients will be measured by the Hospital Anxiety and Depression Scale.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fatigue</measure>
    <time_frame>Baseline, up to 1 month</time_frame>
    <description>Fatigue will be assessed with the Fatigue Severity Scale (FSS). The FSS is a nine-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. The scale addresses fatigue's effects on daily functioning, and its relation to motivation, physical activity, work, family, and social life, and the answers to the problem with which they are fatigued and the degree to which the problem poses a problem for them .</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in quality of sleep</measure>
    <time_frame>Baseline, up to 1 month</time_frame>
    <description>changes in quality of sleep from baseline to postintervention. For this purpose, the participants are going to complete the Pittsburgh Quality of Sleep Index. This is a self-rating questionnaire with seven subscores that result in a global score between 0 and 21.</description>
  </other_outcome>
  <other_outcome>
    <measure>Comorbidities</measure>
    <time_frame>Baseline</time_frame>
    <description>Charlson Comorbidity Index will be used to assess the comorbidities of the patients, it is a simple and valid method of estimating risk of death from comorbid disease. It contains 19 categories of comorbidity and predicts the ten-year mortality for a patient who may have a range of co-morbid conditions. Each condition is assigned with a score of 1, 2, 3 or 6 depending on the risk of dying associated with this condition.</description>
  </other_outcome>
  <other_outcome>
    <measure>Nutritional status</measure>
    <time_frame>Baseline, up to 1 month</time_frame>
    <description>Nutritional status was evaluated with Mini nutritional assessment (MNA) test, that is validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes. The MNA test is composed of simple measurements and brief questions that can be completed in about 10 min.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dyspnoea</measure>
    <time_frame>PBaseline, up to 1 month</time_frame>
    <description>Changes from baseline to postintervention in dyspnoea measured with Borg Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Dependence</measure>
    <time_frame>Baseline, up to 1 month</time_frame>
    <description>The Barthel Index determines the degree of dependence of the patient for performing the basic activities of daily living. It is a questionnaire that consists of 10 items, and at lower score, more dependency; and higher score, more independence.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain</measure>
    <time_frame>Baseline, up to 1 month</time_frame>
    <description>Pain will be assessed by using the Visual Analogue Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Cough</measure>
    <time_frame>Baseline, up to 1 month</time_frame>
    <description>The cough will be assessed with the Leicester cough questionnaire that objectively assesses chronic cough and its effect on quality of life. It is structured in three domains: physical, psychological and social.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain</measure>
    <time_frame>Baseline, up to 1 month</time_frame>
    <description>Pain will be assessed by using a brief pain-specific questionnaire, Brief Pain Inventory, too.</description>
  </other_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Thoracic Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Men and / or women of legal age who are admitted for lung resection, with the approval of&#xD;
        the physician responsible, and who sign the informed consent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient admitted for lung resection and who sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who did not agree to sign informed consent and those who presented other&#xD;
             types of problems to be able to adequately carry out the assessment, such as not&#xD;
             handling the language.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie Carmen Valenza, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Granada</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie Carmen Valenza, PhD</last_name>
    <phone>958248035</phone>
    <email>cvalenza@ugr.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Physical Therapy</name>
      <address>
        <city>Granada</city>
        <zip>18071</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie Carmen Valenza, PhD</last_name>
      <phone>958242360</phone>
      <email>cvalenza@ugr.es</email>
    </contact>
    <investigator>
      <last_name>Marie Carmen Valenza, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>Marie Carmen Valenza</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03300622
org study id: DF0070UG
nct id: NCT03300622
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lung cancer is the leading cause of death in men and the second in women with a 5 year
      survival in Europe of less than 15%. One of the methods most used for its treatment is
      pulmonary resection. The objective of this study is to analyze the clinical profile presented
      to patients after pulmonary resection.
One of the most widely used methods for the treatment of lung cancer is pulmonary resection.
      The morbidity and mortality of pulmonary resection surgery is conditioned by both the type of
      intervention and the patient's condition. Functional deterioration is a risk associated with
      hospitalization in the elderly, with a high prevalence (35-70%) and serious consequences,
      since in the majority it can lead to the appearance of complications not related to the
      reason for admission or the specific treatment. It is very important to evaluate the clinical
      profile of patients after pulmonary resection in order to stablish a more specific
      repercussion.
observational model: Cohort
time perspective: Prospective
measure: Strength in upper and lower limbs
time frame: Baseline, up to 1 month
description: Changes from baseline to postintervention during hospital stay in lower and upper limbs strength. The quadriceps and the hand-grip strength is assessed using a portable dynamometer with a standard protocol allowing three attempts on each side.
measure: Exercise capacity
time frame: Baseline, up to 1 month
description: Five times sit to stand test (5STS) will be used to assess exercise capacity. 5STS is a simple assessment tool that is feasible in all healthcare settings and involves asking the patient to stand up 5 times for the shortest possible time without arm support.. Saturation and heart rate will be monitored as well as levels of dyspnea and fatigue of the patient.
measure: Mood
time frame: Baseline, up to 1 month
description: Mood in these patients will be measured by the Hospital Anxiety and Depression Scale.
measure: Fatigue
time frame: Baseline, up to 1 month
description: Fatigue will be assessed with the Fatigue Severity Scale (FSS). The FSS is a nine-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. The scale addresses fatigue's effects on daily functioning, and its relation to motivation, physical activity, work, family, and social life, and the answers to the problem with which they are fatigued and the degree to which the problem poses a problem for them .
measure: Changes in quality of sleep
time frame: Baseline, up to 1 month
description: changes in quality of sleep from baseline to postintervention. For this purpose, the participants are going to complete the Pittsburgh Quality of Sleep Index. This is a self-rating questionnaire with seven subscores that result in a global score between 0 and 21.
measure: Comorbidities
time frame: Baseline
description: Charlson Comorbidity Index will be used to assess the comorbidities of the patients, it is a simple and valid method of estimating risk of death from comorbid disease. It contains 19 categories of comorbidity and predicts the ten-year mortality for a patient who may have a range of co-morbid conditions. Each condition is assigned with a score of 1, 2, 3 or 6 depending on the risk of dying associated with this condition.
measure: Nutritional status
time frame: Baseline, up to 1 month
description: Nutritional status was evaluated with Mini nutritional assessment (MNA) test, that is validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes. The MNA test is composed of simple measurements and brief questions that can be completed in about 10 min.
measure: Dyspnoea
time frame: PBaseline, up to 1 month
description: Changes from baseline to postintervention in dyspnoea measured with Borg Scale
measure: Dependence
time frame: Baseline, up to 1 month
description: The Barthel Index determines the degree of dependence of the patient for performing the basic activities of daily living. It is a questionnaire that consists of 10 items, and at lower score, more dependency; and higher score, more independence.
measure: Pain
time frame: Baseline, up to 1 month
description: Pain will be assessed by using the Visual Analogue Scale
measure: Cough
time frame: Baseline, up to 1 month
description: The cough will be assessed with the Leicester cough questionnaire that objectively assesses chronic cough and its effect on quality of life. It is structured in three domains: physical, psychological and social.
measure: Pain
time frame: Baseline, up to 1 month
description: Pain will be assessed by using a brief pain-specific questionnaire, Brief Pain Inventory, too.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie Carmen Valenza, PT, PhD
role: Principal Investigator
affiliation: Universidad de Granada
last name: Marie Carmen Valenza, PhD
phone: 958248035
email: cvalenza@ugr.es
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: Marie Carmen Valenza
investigator title: Principal Investigator
mesh term: Aortic Dissection
sharing ipd: Undecided