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/NCT06008470</url>
    </required_header>
    <id_info>
      <org_study_id>Gurbuz04</org_study_id>
      <nct_id>NCT06008470</nct_id>
    </id_info>
    <brief_title>Investigation of Respiratory Muscle Strength, Exercise Capacity, Physical Activity and Sleep Quality Level in Individuals With Covid-19 Infection</brief_title>
    <official_title>Investigation of Respiratory Muscle Strength, Exercise Capacity, Physical Activity and Sleep Quality Level in Individuals With Covid-19 Infection</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kırıkkale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kırıkkale 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>
        COVID-19 infection was identified in Wuhan, China at the end of 2019 and turned into a&#xD;
        pandemic in a short time. In our country, the pandemic continues at full speed and patients&#xD;
        are being treated in various clinical pictures. In its clinical classification, the World&#xD;
        Health Organization (WHO) divides COVID-19 disease into four stages: mild symptomatic&#xD;
        disease, pneumonia, severe pneumonia, acute respiratory distress syndrome (ARDS), sepsis and&#xD;
        advanced stage with septic shock. Case reports and cross-sectional studies report a list of&#xD;
        more than 200 different symptoms in the development of post COVID-19 syndrome. Shortness of&#xD;
        breath, persistent smell and taste disturbances, fatigue and neuropsychological symptoms&#xD;
        (headache, memory loss, slowed thinking, anxiety, depression and sleep disturbances) are the&#xD;
        most commonly reported symptoms. Musculoskeletal symptoms such as pain (myalgia), muscle&#xD;
        weakness, arthralgia and fatigue are also common. Exercise endurance tests are used to&#xD;
        predict the prognosis of the disease in chronic lung diseases, to determine functional&#xD;
        exercise capacity, to evaluate the response of the disease to treatment and to interpret the&#xD;
        results of clinical trials. Covid-19-induced lung infections and long periods of isolation&#xD;
        may have negative effects on respiratory muscle strength, pulmonary function values and&#xD;
        physical activity level. It has been reported that only one week of bed rest can cause&#xD;
        serious muscle loss of up to 20%. Covid-19 infection increases the likelihood of asthma-like&#xD;
        symptoms. In some cases, pneumonia and increased dyspnea are also seen. When volleyball&#xD;
        players with Covid-19 infection were examined, respiratory muscle strength and fev1/fvc&#xD;
        values were lower than expected.&#xD;
  &#xD;
        When looking at the interaction between infections and sleep, it was observed that different&#xD;
        infections had different effects on sleep, with some infections increasing the amount of&#xD;
        sleep while others decreased it. The increase in inflammatory mediators associated with&#xD;
        systemic infection is thought to increase the amount of REM sleep and total sleep duration,&#xD;
        perhaps in an effort to conserve energy and counteract infection. Some infections have a&#xD;
        negative effect on the immune system, reducing the amount of sleep. Covid infection is also&#xD;
        thought to have negative effects on sleep. The symptoms of COVID-19 in the chronic phase can&#xD;
        further negatively affect physiological, psychological and social outcomes, physical activity&#xD;
        and ultimately muscle performance and quality. Post-infection physical function and fitness&#xD;
        can worsen even two years after the disease.&#xD;
  &#xD;
        In COVID-19 patients recovering 3 months after hospital discharge, limitations were mainly&#xD;
        related to reduced muscle mass, low oxidative capacity or both, rather than cardiac or&#xD;
        respiratory exercise limitation.&#xD;
  &#xD;
        Symptoms experienced during Covid-19 infection are thought to have negative effects on&#xD;
        exercise endurance. In order to meet the metabolic needs of the musculoskeletal system&#xD;
        muscles during exercise, cardiac output, ventilation, pulmonary and systemic blood flow,&#xD;
        oxygen and carbon dioxide exchange in a way to maintain acid-base balance and oxygenation,&#xD;
        and their compatible response to each other are required. Exercise endurance assessments are&#xD;
        an important parameter to determine the functional level of the patient. Eighty-eight percent&#xD;
        of individuals with Covid-19 infection showed a decrease in respiratory muscle strength in&#xD;
        the evaluation performed 5 months later. The direct effect of respiratory muscles may cause&#xD;
        permanent dyspnea problems. Muscle strength, exercise capacity, dyspnea perception, fatigue&#xD;
        severity perception, pain, balance, kinesiophobia, psychosocial and cognitive status, quality&#xD;
        of life should be routinely evaluated in the post-COVID-19 period in patients admitted to the&#xD;
        clinic, and a targeted functional rehabilitation program should be prepared in the light of&#xD;
        these evaluations, taking these parameters into consideration during the rehabilitation&#xD;
        process.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">January 5, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>6 Minute Walk Test (6MWT):</measure>
      <time_frame>6 min</time_frame>
      <description>The 6DYT is a simple, low-cost test that monitors blood pressure (BP), heart rate (HR), respiratory frequency (RF), 'pulse' oxygen saturation (SpO2), score on the Borg Scale and distance walked. This test allows determination of physical fitness and VO2max and also assesses the patient's capacity and exercise tolerance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep Quality Level(pitsburg sleep scale)</measure>
      <time_frame>5 minute</time_frame>
      <description>The PSQI was developed by Buysse et al. (1989) and adapted into Turkish by Ağargün et al. (1996). The PSQI is a 19-item self-report scale that evaluates sleep quality and disturbance in the past one month. It consists of 24 questions, 19 questions are self-report questions and 5 questions are questions to be answered by a spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficacy, Sleep Disorder, Sleep Medication Use and Daytime Dysfunction. Each component is evaluated on a 0-3 point scale. The total score of the 7 components gives the total scale score. The total score ranges from 0-21. A total score greater than 5 indicates &quot;poor sleep quality&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory Muscle Strength Measurement</measure>
      <time_frame>10 min</time_frame>
      <description>In our study, respiratory muscle strength will be measured using a portable, electronic mouth pressure measuring device (MEC Pocket Spiro MPM100, Belgium). Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurement is one of the most commonly used non-invasive methods to evaluate respiratory muscles</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>COVID-19</condition>
    <condition>Sleep Disorder</condition>
    <condition>Respiratory Failure</condition>
    <arm_group>
      <arm_group_label>covid-19</arm_group_label>
      <description>Inclusion Criteria:&#xD;
  Literacy,&#xD;
  To be between the ages of 18-45,&#xD;
  To study at Kırıkkale University Faculty of Health Sciences&#xD;
  Volunteering to participate in the research,</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>observational tests</intervention_name>
      <description>Respiratory Muscle Strength Measurement In our study, respiratory muscle strength will be measured using a portable, electronic mouth pressure measuring device (MEC Pocket Spiro MPM100, Belgium). Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurement is one of the most commonly used non-invasive methods to evaluate respiratory muscles.&#xD;
  6 Minute Walk Test (6MWT): It has been used to assess physical activity and functional capacity in many pulmonary rehabilitation programs for patients with chronic pulmonary disease and limited respiratory capacity</description>
      <arm_group_label>control</arm_group_label>
      <arm_group_label>covid-19</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          As a result of the power analysis performed according to the sample article, it was&#xD;
          calculated that 95% power would be obtained with 95% confidence when 30 people were&#xD;
          included in each group for a total of 60 people. The MMP value was taken as the primary&#xD;
          outcome measure. The impact factor was calculated as 0.958. Individuals will be selected&#xD;
          from the students of our department. 30 people are post-covid, 30 people are healthy&#xD;
          control group&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  - Literacy,&#xD;
  &#xD;
            -  To be between the ages of 18-45,&#xD;
  &#xD;
            -  To study at Kırıkkale University Faculty of Health Sciences&#xD;
  &#xD;
            -  Volunteering to participate in the research,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  - Individuals who are professional athletes with musculoskeletal system,&#xD;
               cardiopulmonary system, metabolic system and other systemic problems that may affect&#xD;
               physical activity habits will not be included in the study.&#xD;
  &#xD;
            -  A repeat COVID-19 PCR test positivity within the last 12 weeks&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Alper K Gürbüz, master</last_name>
      <phone>+905364014402</phone>
      <email>alperkemal4@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kırıkkale University</name>
        <address>
          <city>Kirikkale</city>
          <zip>71450</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alper Gürbüz</last_name>
        <email>alperkemal4@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kırıkkale University</investigator_affiliation>
      <investigator_full_name>Alper Kemal Gürbüz</investigator_full_name>
      <investigator_title>research asistant</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Respiratory Insufficiency</mesh_term>
      <mesh_term>Sleep Wake Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06008470
  org study id: Gurbuz04
  nct id: NCT06008470
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  COVID-19 infection was identified in Wuhan, China at the end of 2019 and turned into a
        pandemic in a short time. In our country, the pandemic continues at full speed and patients
        are being treated in various clinical pictures. In its clinical classification, the World
        Health Organization (WHO) divides COVID-19 disease into four stages: mild symptomatic
        disease, pneumonia, severe pneumonia, acute respiratory distress syndrome (ARDS), sepsis and
        advanced stage with septic shock. Case reports and cross-sectional studies report a list of
        more than 200 different symptoms in the development of post COVID-19 syndrome. Shortness of
        breath, persistent smell and taste disturbances, fatigue and neuropsychological symptoms
        (headache, memory loss, slowed thinking, anxiety, depression and sleep disturbances) are the
        most commonly reported symptoms. Musculoskeletal symptoms such as pain (myalgia), muscle
        weakness, arthralgia and fatigue are also common. Exercise endurance tests are used to
        predict the prognosis of the disease in chronic lung diseases, to determine functional
        exercise capacity, to evaluate the response of the disease to treatment and to interpret the
        results of clinical trials. Covid-19-induced lung infections and long periods of isolation
        may have negative effects on respiratory muscle strength, pulmonary function values and
        physical activity level. It has been reported that only one week of bed rest can cause
        serious muscle loss of up to 20%. Covid-19 infection increases the likelihood of asthma-like
        symptoms. In some cases, pneumonia and increased dyspnea are also seen. When volleyball
        players with Covid-19 infection were examined, respiratory muscle strength and fev1/fvc
        values were lower than expected.
  
        When looking at the interaction between infections and sleep, it was observed that different
        infections had different effects on sleep, with some infections increasing the amount of
        sleep while others decreased it. The increase in inflammatory mediators associated with
        systemic infection is thought to increase the amount of REM sleep and total sleep duration,
        perhaps in an effort to conserve energy and counteract infection. Some infections have a
        negative effect on the immune system, reducing the amount of sleep. Covid infection is also
        thought to have negative effects on sleep. The symptoms of COVID-19 in the chronic phase can
        further negatively affect physiological, psychological and social outcomes, physical activity
        and ultimately muscle performance and quality. Post-infection physical function and fitness
        can worsen even two years after the disease.
  
        In COVID-19 patients recovering 3 months after hospital discharge, limitations were mainly
        related to reduced muscle mass, low oxidative capacity or both, rather than cardiac or
        respiratory exercise limitation.
  
        Symptoms experienced during Covid-19 infection are thought to have negative effects on
        exercise endurance. In order to meet the metabolic needs of the musculoskeletal system
        muscles during exercise, cardiac output, ventilation, pulmonary and systemic blood flow,
        oxygen and carbon dioxide exchange in a way to maintain acid-base balance and oxygenation,
        and their compatible response to each other are required. Exercise endurance assessments are
        an important parameter to determine the functional level of the patient. Eighty-eight percent
        of individuals with Covid-19 infection showed a decrease in respiratory muscle strength in
        the evaluation performed 5 months later. The direct effect of respiratory muscles may cause
        permanent dyspnea problems. Muscle strength, exercise capacity, dyspnea perception, fatigue
        severity perception, pain, balance, kinesiophobia, psychosocial and cognitive status, quality
        of life should be routinely evaluated in the post-COVID-19 period in patients admitted to the
        clinic, and a targeted functional rehabilitation program should be prepared in the light of
        these evaluations, taking these parameters into consideration during the rehabilitation
        process.
  observational model: Case-Control
  time perspective: Prospective
  measure: 6 Minute Walk Test (6MWT):
  time frame: 6 min
  description: The 6DYT is a simple, low-cost test that monitors blood pressure (BP), heart rate (HR), respiratory frequency (RF), 'pulse' oxygen saturation (SpO2), score on the Borg Scale and distance walked. This test allows determination of physical fitness and VO2max and also assesses the patient's capacity and exercise tolerance.
  measure: Sleep Quality Level(pitsburg sleep scale)
  time frame: 5 minute
  description: The PSQI was developed by Buysse et al. (1989) and adapted into Turkish by Ağargün et al. (1996). The PSQI is a 19-item self-report scale that evaluates sleep quality and disturbance in the past one month. It consists of 24 questions, 19 questions are self-report questions and 5 questions are questions to be answered by a spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficacy, Sleep Disorder, Sleep Medication Use and Daytime Dysfunction. Each component is evaluated on a 0-3 point scale. The total score of the 7 components gives the total scale score. The total score ranges from 0-21. A total score greater than 5 indicates "poor sleep quality"
  measure: Respiratory Muscle Strength Measurement
  time frame: 10 min
  description: In our study, respiratory muscle strength will be measured using a portable, electronic mouth pressure measuring device (MEC Pocket Spiro MPM100, Belgium). Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurement is one of the most commonly used non-invasive methods to evaluate respiratory muscles
  arm group label: covid-19
  description: Inclusion Criteria:
  Literacy,
  To be between the ages of 18-45,
  To study at Kırıkkale University Faculty of Health Sciences
  Volunteering to participate in the research,
  arm group label: control
  intervention type: Other
  intervention name: observational tests
  description: Respiratory Muscle Strength Measurement In our study, respiratory muscle strength will be measured using a portable, electronic mouth pressure measuring device (MEC Pocket Spiro MPM100, Belgium). Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurement is one of the most commonly used non-invasive methods to evaluate respiratory muscles.
  6 Minute Walk Test (6MWT): It has been used to assess physical activity and functional capacity in many pulmonary rehabilitation programs for patients with chronic pulmonary disease and limited respiratory capacity
  arm group label: control
  arm group label: covid-19
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alper K Gürbüz, master
  phone: +905364014402
  email: alperkemal4@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Kırıkkale University
  investigator full name: Alper Kemal Gürbüz
  investigator title: research asistant
  mesh term: COVID-19
  mesh term: Respiratory Insufficiency
  mesh term: Sleep Wake Disorders
  sharing ipd: Undecided