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/NCT06002334</url>
    </required_header>
    <id_info>
      <org_study_id>muscle weaknessinbroncheactsis</org_study_id>
      <nct_id>NCT06002334</nct_id>
    </id_info>
    <brief_title>Relationship Between Nutritional State and Respiratory Muscle Weakness in Adult Patients With Bronchietasis</brief_title>
    <official_title>Relationship Between Nutritional State and Respiratory Muscle Weakness in Adult Patients With Bronchietasis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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>
        To establish a relationship between malnutrion and respiratory muscle dysfunction in patients&#xD;
        with bronchectasis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Many different and prevalent chronic respiratory disorders, such as chronic obstructive&#xD;
        pulmonary disease (COPD), cystic fibrosis (CF), non-CF bronchiectasis, idiopathic pulmonary&#xD;
        fibrosis (IPF) and lung cancer, not only target the lungs but are often associated with&#xD;
        systemic manifestations (1-5). The latter can be magnified by the concomitant presence of&#xD;
        aging, comorbidities or unhealthy lifestyle habits. Nutritional abnormalities stand out&#xD;
        amongst the systemic manifestations present in chronic respiratory conditions. When these&#xD;
        nutritional abnormalities become very severe, with marked weight and muscle mass loss, they&#xD;
        constitute a complex metabolic syndrome, known as cachexia. However, it should be kept in&#xD;
        mind that the earliest stages of nutritional abnormalities do not necessarily involve evident&#xD;
        body weight loss. Diagnosis and stratification of patients with impaired nutritional status&#xD;
        is important to decide the appropriate therapeutic approach. In fact, it has been clearly&#xD;
        demonstrated that therapeutic interventions, even with only moderate increases in body weight&#xD;
        or lean mass, can improve the prognosis of respiratory patients with nutritional&#xD;
        abnormalities (6). Therefore, medical professionals should be able to detect these&#xD;
        deficiencies early.&#xD;
  &#xD;
        One of the most important clinical consequences of nutritional deficiencies in patients with&#xD;
        chronic respiratory disorders is the loss of muscle mass and functional impairment (2,4,9).&#xD;
        However, nutritional deficiencies not only affect muscle mass and function, but can also have&#xD;
        a negative impact on bone and fat tissues, reaching a state of severe cachexia in the more&#xD;
        advanced situations. Moreover, malnutrition also targets patient's immunocompetence,&#xD;
        facilitating infections and exacerbations, which reciprocally will contribute to worsen&#xD;
        nutritional status.&#xD;
  &#xD;
        Muscle dysfunction is defined by the loss of strength (i.e., the ability to develop a maximal&#xD;
        effort and/or endurance (i.e., the ability to maintain a submaximal effort through time)&#xD;
        (10,11). This functional impairment can be relatively stable (this is known as 'muscle&#xD;
        weakness') or temporary (denominated 'fatigue', which is reversible with rest) (10,11).&#xD;
        Muscle dysfunction can involve peripheral (limb) as well as respiratory muscles, and can&#xD;
        appear in acute or chronic respiratory diseases due to different causes. However, the loss of&#xD;
        muscle mass is probably the main one, at least for limb muscles, having deleterious&#xD;
        consequences on patients' prognosis (12,13). The term 'loss of muscle mass' is generally used&#xD;
        to express a decrease in global muscle proportion or weight, but at a cellular level it&#xD;
        actually indicates the loss of fibers or more frequently, a reduction in their size. The loss&#xD;
        of muscle mass is mainly because of a decrease in muscle contractile protein content through&#xD;
        different mechanisms, including the activation of the ubiquitin-proteasome system, autophagy&#xD;
        and apoptosis (14). Global muscle mass and fiber size are the main factors contributing to&#xD;
        muscle strength, although other components such as fiber type proportions and muscle length&#xD;
        also play a relevant role (12). Therefore, a loss in either muscle mass or fiber atrophy will&#xD;
        involve a decrease in contractile strength. On the other hand, endurance depends mostly on&#xD;
        the muscle aerobic capacity, which in turn is a subrogate of the percentage of fibers with a&#xD;
        predominant aerobic metabolism ('slow-twitch' fibers), capillary and mitochondrial density,&#xD;
        and the capacity of oxidative enzymes on metabolic pathways (12).&#xD;
  &#xD;
        The presence of limb muscle dysfunction can even limit normal walking, leading to a reduction&#xD;
        of patient daily activities and social life, with a strong negative impact on prognosis,&#xD;
        quality of life, and utilization of social and health resources (3,7,8,15-18). Respiratory&#xD;
        muscle dysfunction in turn is associated with increased dyspnea (10,11,19), a worse&#xD;
        ventilatory response to both exercise and exacerbations (19-21), and can even lead to severe&#xD;
        respiratory failure, as well as weaning difficulties in patients submitted to mechanical&#xD;
        ventilation (22,23).&#xD;
  &#xD;
        Bronchiectasis, defined as the abnormal and irreversible dilation of the bronchi, are&#xD;
        frequently observed even in general population, especially since the wide use of the&#xD;
        high-resolution computed tomography (122). Although bronchiectasis can be the result of&#xD;
        different processes, they are currently classified in those linked to CF and those that are&#xD;
        independent of such a genetic alteration (non-CF), being the latter much more prevalent&#xD;
        (123-125). Moreover, the above-mentioned advances in image techniques have allowed for the&#xD;
        identification of a variable number of COPD patients who also have bronchiectasis to a&#xD;
        greater or lesser extent (1). Although the most common clinical presentation of non-CF&#xD;
        bronchiectasis is the presence of daily cough with abundant sputum and repeated infections&#xD;
        (123,124), nutritional abnormalities are also frequent (2). Since many of the deleterious&#xD;
        factors present in COPD are also present in non-CF bronchiectasis (local and systemic&#xD;
        inflammation, exacerbations, ventilatory limitation, deconditioning, etc.) (126,127), it&#xD;
        could be speculated that muscle dysfunction would also be frequent in this case. However, the&#xD;
        actual prevalence of this disorder in non-CF bronchiectasis remains unclear. Respiratory&#xD;
        muscle dysfunction has only been occasionally described in this lung disease (2,126,128,129)&#xD;
        and, so far little attention has been given to the eventual presence of limb muscle&#xD;
        malfunctioning. In fact, only isolated reports suggest that this latter abnormality is common&#xD;
        in non-CF bronchiectasis (130,131) and exercise tolerance can also be reduced (126).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">February 23, 2023</start_date>
    <completion_date type="Anticipated">June 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 23, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To establish a relationship between malnutrion and respiratory muscle dysfunction in patients with bronchectasis</measure>
      <time_frame>1 year</time_frame>
      <description>To establish a relationship between malnutrion and respiratory muscle dysfunction in patients with bronchectasis</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Bronchiectasis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          adult patient with bronchectasis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients of both genders who have bronchiectasis based on imaging&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients less than 18 years old Patients with neuromuscular disorders, muscle dystrophies&#xD;
          or other causes of muscle weakness&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of medicine, Assiut University</name>
        <address>
          <city>Assiut</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Abdelrahman Galal Salih</investigator_full_name>
      <investigator_title>demonstrator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Muscle Weakness</mesh_term>
      <mesh_term>Bronchiectasis</mesh_term>
      <mesh_term>Paresis</mesh_term>
    </condition_browse>
    <!-- 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/NCT06002334
  org study id: muscle weaknessinbroncheactsis
  nct id: NCT06002334
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To establish a relationship between malnutrion and respiratory muscle dysfunction in patients
        with bronchectasis
  Many different and prevalent chronic respiratory disorders, such as chronic obstructive
        pulmonary disease (COPD), cystic fibrosis (CF), non-CF bronchiectasis, idiopathic pulmonary
        fibrosis (IPF) and lung cancer, not only target the lungs but are often associated with
        systemic manifestations (1-5). The latter can be magnified by the concomitant presence of
        aging, comorbidities or unhealthy lifestyle habits. Nutritional abnormalities stand out
        amongst the systemic manifestations present in chronic respiratory conditions. When these
        nutritional abnormalities become very severe, with marked weight and muscle mass loss, they
        constitute a complex metabolic syndrome, known as cachexia. However, it should be kept in
        mind that the earliest stages of nutritional abnormalities do not necessarily involve evident
        body weight loss. Diagnosis and stratification of patients with impaired nutritional status
        is important to decide the appropriate therapeutic approach. In fact, it has been clearly
        demonstrated that therapeutic interventions, even with only moderate increases in body weight
        or lean mass, can improve the prognosis of respiratory patients with nutritional
        abnormalities (6). Therefore, medical professionals should be able to detect these
        deficiencies early.
  
        One of the most important clinical consequences of nutritional deficiencies in patients with
        chronic respiratory disorders is the loss of muscle mass and functional impairment (2,4,9).
        However, nutritional deficiencies not only affect muscle mass and function, but can also have
        a negative impact on bone and fat tissues, reaching a state of severe cachexia in the more
        advanced situations. Moreover, malnutrition also targets patient's immunocompetence,
        facilitating infections and exacerbations, which reciprocally will contribute to worsen
        nutritional status.
  
        Muscle dysfunction is defined by the loss of strength (i.e., the ability to develop a maximal
        effort and/or endurance (i.e., the ability to maintain a submaximal effort through time)
        (10,11). This functional impairment can be relatively stable (this is known as 'muscle
        weakness') or temporary (denominated 'fatigue', which is reversible with rest) (10,11).
        Muscle dysfunction can involve peripheral (limb) as well as respiratory muscles, and can
        appear in acute or chronic respiratory diseases due to different causes. However, the loss of
        muscle mass is probably the main one, at least for limb muscles, having deleterious
        consequences on patients' prognosis (12,13). The term 'loss of muscle mass' is generally used
        to express a decrease in global muscle proportion or weight, but at a cellular level it
        actually indicates the loss of fibers or more frequently, a reduction in their size. The loss
        of muscle mass is mainly because of a decrease in muscle contractile protein content through
        different mechanisms, including the activation of the ubiquitin-proteasome system, autophagy
        and apoptosis (14). Global muscle mass and fiber size are the main factors contributing to
        muscle strength, although other components such as fiber type proportions and muscle length
        also play a relevant role (12). Therefore, a loss in either muscle mass or fiber atrophy will
        involve a decrease in contractile strength. On the other hand, endurance depends mostly on
        the muscle aerobic capacity, which in turn is a subrogate of the percentage of fibers with a
        predominant aerobic metabolism ('slow-twitch' fibers), capillary and mitochondrial density,
        and the capacity of oxidative enzymes on metabolic pathways (12).
  
        The presence of limb muscle dysfunction can even limit normal walking, leading to a reduction
        of patient daily activities and social life, with a strong negative impact on prognosis,
        quality of life, and utilization of social and health resources (3,7,8,15-18). Respiratory
        muscle dysfunction in turn is associated with increased dyspnea (10,11,19), a worse
        ventilatory response to both exercise and exacerbations (19-21), and can even lead to severe
        respiratory failure, as well as weaning difficulties in patients submitted to mechanical
        ventilation (22,23).
  
        Bronchiectasis, defined as the abnormal and irreversible dilation of the bronchi, are
        frequently observed even in general population, especially since the wide use of the
        high-resolution computed tomography (122). Although bronchiectasis can be the result of
        different processes, they are currently classified in those linked to CF and those that are
        independent of such a genetic alteration (non-CF), being the latter much more prevalent
        (123-125). Moreover, the above-mentioned advances in image techniques have allowed for the
        identification of a variable number of COPD patients who also have bronchiectasis to a
        greater or lesser extent (1). Although the most common clinical presentation of non-CF
        bronchiectasis is the presence of daily cough with abundant sputum and repeated infections
        (123,124), nutritional abnormalities are also frequent (2). Since many of the deleterious
        factors present in COPD are also present in non-CF bronchiectasis (local and systemic
        inflammation, exacerbations, ventilatory limitation, deconditioning, etc.) (126,127), it
        could be speculated that muscle dysfunction would also be frequent in this case. However, the
        actual prevalence of this disorder in non-CF bronchiectasis remains unclear. Respiratory
        muscle dysfunction has only been occasionally described in this lung disease (2,126,128,129)
        and, so far little attention has been given to the eventual presence of limb muscle
        malfunctioning. In fact, only isolated reports suggest that this latter abnormality is common
        in non-CF bronchiectasis (130,131) and exercise tolerance can also be reduced (126).
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: To establish a relationship between malnutrion and respiratory muscle dysfunction in patients with bronchectasis
  time frame: 1 year
  description: To establish a relationship between malnutrion and respiratory muscle dysfunction in patients with bronchectasis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Abdelrahman Galal Salih
  investigator title: demonstrator
  mesh term: Muscle Weakness
  mesh term: Bronchiectasis
  mesh term: Paresis