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/NCT06028711</url>
    </required_header>
    <id_info>
      <org_study_id>URzeszow/2023/06/0034/W</org_study_id>
      <nct_id>NCT06028711</nct_id>
    </id_info>
    <brief_title>Education Impact on Rehabilitation of Hospitalized Patients With Chronic Obstructive Pulmonary Disease.</brief_title>
    <official_title>The Impact of Education on the Rehabilitation of Patients Hospitalized Due to Chronic Obstructive Pulmonary Disease.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Rzeszow</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Rzeszow</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 planned research will enable the assessment of rehabilitation's effects using two&#xD;
        pulmonary rehabilitation models: conventional and supplemented with an education program for&#xD;
        patients hospitalized due to chronic obstructive pulmonary disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The planned group size is 100 patients diagnosed with chronic obstructive pulmonary disease&#xD;
        (COPD) and hospitalized due to exacerbation. The given population was calculated based on the&#xD;
        sampling calculator, considering the following parameters: fraction size, confidence level,&#xD;
        and maximum error.&#xD;
  &#xD;
        Eligible patients will be randomly divided into two groups: a study group (50 patients)&#xD;
        undergoing pulmonary rehabilitation supplemented with an education program and a control&#xD;
        group (50 patients) undergoing conventional pulmonary rehabilitation.&#xD;
  &#xD;
        Patients of both groups will be included in a 14-day rehabilitation program (Monday to&#xD;
        Saturday). Treatments and therapies will be continued for a maximum of two hours daily. The&#xD;
        program will be applied individually to each patient, including active and assisted&#xD;
        exercises, effective cough exercises, pursed-lips breathing, positive expiratory pressure&#xD;
        exercises, exercises to strengthen the diaphragm and intercostal muscles, and cardiopulmonary&#xD;
        exercises. Patients from the study group will additionally undergo daily education using an&#xD;
        original brochure containing information on the benefits of appropriately adapted physical&#xD;
        activity, practical tips on airway clearance techniques or physical exercise, and risk&#xD;
        factors for exacerbation of COPD.&#xD;
  &#xD;
        The test will be performed three times: before the start of rehabilitation, after completing&#xD;
        the rehabilitation program, and the follow-up after two months from the end of&#xD;
        hospitalization to assess long-term effects. After the end of the study, people from the&#xD;
        control group will also undergo education.&#xD;
  &#xD;
        The patients' condition and the rehabilitation effects will be assessed using the following&#xD;
        measures:&#xD;
  &#xD;
          -  Dynamic lung capacities (spirometry)&#xD;
  &#xD;
          -  Oxygen saturation and pulse rate (pulse oximeter)&#xD;
  &#xD;
          -  Acid-base balance (gasometry)&#xD;
  &#xD;
          -  Exercise tolerance (6-minute walking test)&#xD;
  &#xD;
          -  Fatigue (modified Borg scale)&#xD;
  &#xD;
          -  Physical performance (Fullerton functional fitness test)&#xD;
  &#xD;
          -  Dyspnea assessment (MRC dyspnea scale)&#xD;
  &#xD;
          -  Quality of life (WHOQOL-BREF)&#xD;
  &#xD;
          -  Anxiety and depression (HADS scale)&#xD;
  &#xD;
          -  Activities of daily living (Lawton IADL scale)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>
      <intervention_model_description>random selection to two groups (study group and control group)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Dynamic lung capacities (spirometry)</measure>
      <time_frame>First examination- before the start of the interventions</time_frame>
      <description>Measurements will be performed with certified spirometer and the parameters analyzed will be Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) measured in litres [L].</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dynamic lung capacities (spirometry)</measure>
      <time_frame>Second examination- at the end of the 14-day rehabilitation program</time_frame>
      <description>Measurements will be performed with certified spirometer and the parameters analyzed will be Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) measured in litres [L].</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Modified Tiffeneau-Pinelli index (spirometry)</measure>
      <time_frame>First examination- before the start of the interventions</time_frame>
      <description>Measurement will be performed with certified spirometer and the parameter analyzed will be the ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC ratio) presented as a decimal fraction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Modified Tiffeneau-Pinelli index (spirometry)</measure>
      <time_frame>Second examination- at the end of the 14-day rehabilitation program</time_frame>
      <description>Measurement will be performed with certified spirometer and the parameter analyzed will be the ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC ratio) presented as a decimal fraction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oxygen saturation</measure>
      <time_frame>First examination- before the start of the interventions</time_frame>
      <description>Measurements will be performed with pulse oximeter and the parameter analyzed will be oxygen saturation by pulse oximetry (SpO2, percentage of oxygen in patients' blood).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oxygen saturation</measure>
      <time_frame>Second examination- at the end of the 14-day rehabilitation program</time_frame>
      <description>Measurements will be performed with pulse oximeter and the parameter analyzed will be oxygen saturation by pulse oximetry (SpO2, percentage of oxygen in patients' blood).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pulse rate</measure>
      <time_frame>First examination- before the start of the interventions</time_frame>
      <description>Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pulse rate</measure>
      <time_frame>Second examination- at the end of the 14-day rehabilitation program</time_frame>
      <description>Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acid-base balance</measure>
      <time_frame>First examination- before the start of the interventions</time_frame>
      <description>The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acid-base balance</measure>
      <time_frame>Second examination- at the end of the 14-day rehabilitation program</time_frame>
      <description>The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Exercise tolerance assessed by 6-minute walking test (6MWT)</measure>
      <time_frame>First examination- before the start of the interventions</time_frame>
      <description>The test will be performed in 20-meter long hospital corridor. The patient should walk the distance at his own rhythm and pace, using orthopedic aids (if necessary). The patient will be informed that they can stop the test at any time if they feel it is necessary. The distance traveled in meters in 6 minutes will be analyzed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Exercise tolerance assessed by 6-minute walking test (6MWT)</measure>
      <time_frame>Second examination- at the end of the 14-day rehabilitation program</time_frame>
      <description>The test will be performed in 20-meter long hospital corridor. The patient should walk the distance at his own rhythm and pace, using orthopedic aids (if necessary). The patient will be informed that they can stop the test at any time if they feel it is necessary. The distance traveled in meters in 6 minutes will be analyzed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physical performance assessment by Fullerton functional fitness test</measure>
      <time_frame>First examination- before the start of the interventions</time_frame>
      <description>The test comprising muscle endurance, aerobic capacity, flexibility, agility, and balance assessment. The test consist of 6 activities: 1. Arm Curl Test (number of forearm flexions in 30 seconds); 2. Back Scratch (the distance between middle fingers); 3. 30 Second Chair Stand (number of standings in 30 seconds); 4. Chair Sit-and-Reach ( '+' if fingers can reach toes in sitting position, '-' if fingers cannot reach toes in sitting position); 5. 8 - Foot Up-and-Go (8-foot walking time); 6. 2-Minute Step-in-Place (the number of lifts of the right leg).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physical performance assessment by Fullerton functional fitness test</measure>
      <time_frame>Second examination- at the end of the 14-day rehabilitation program</time_frame>
      <description>The test comprising muscle endurance, aerobic capacity, flexibility, agility, and balance assessment. The test consist of 6 activities: 1. Arm Curl Test (number of forearm flexions in 30 seconds); 2. Back Scratch (the distance between middle fingers); 3. 30 Second Chair Stand (number of standings in 30 seconds); 4. Chair Sit-and-Reach ( '+' if fingers can reach toes in sitting position, '-' if fingers cannot reach toes in sitting position); 5. 8 - Foot Up-and-Go (8-foot walking time); 6. 2-Minute Step-in-Place (the number of lifts of the right leg).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue assessment using modified Borg scale</measure>
      <time_frame>First examination- before the start of the interventions</time_frame>
      <description>Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue assessment using modified Borg scale</measure>
      <time_frame>Second examination- at the end of the 14-day rehabilitation program</time_frame>
      <description>Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue assessment using modified Borg scale</measure>
      <time_frame>Third examination - two months after discharge from the hospital (follow- up)</time_frame>
      <description>Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dyspnea assessment with Medical Research Council dyspnea scale</measure>
      <time_frame>First examination- before the start of the interventions</time_frame>
      <description>Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dyspnea assessment with Medical Research Council dyspnea scale</measure>
      <time_frame>Second examination- at the end of the 14-day rehabilitation program</time_frame>
      <description>Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dyspnea assessment with Medical Research Council dyspnea scale</measure>
      <time_frame>Third examination - two months after discharge from the hospital (follow- up)</time_frame>
      <description>Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)</measure>
      <time_frame>First examination- before the start of the interventions</time_frame>
      <description>Assessment of quality of life, health and other areas. The scale contains 26 items, divided into four domains: physical health (7 items), psychological health (6 items), social relations (3 items), and environmental health (8 items), as well overall quality of life and general health (2 items). Patients express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). The final score is transformed linearly to a 0-100-scale, where higher scores denote higher quality of life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)</measure>
      <time_frame>Second examination- at the end of the 14-day rehabilitation program</time_frame>
      <description>Assessment of quality of life, health and other areas. The scale contains 26 items, divided into four domains: physical health (7 items), psychological health (6 items), social relations (3 items), and environmental health (8 items), as well overall quality of life and general health (2 items). Patients express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). The final score is transformed linearly to a 0-100-scale, where higher scores denote higher quality of life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)</measure>
      <time_frame>Third examination - two months after discharge from the hospital (follow- up)</time_frame>
      <description>Assessment of quality of life, health and other areas. The scale contains 26 items, divided into four domains: physical health (7 items), psychological health (6 items), social relations (3 items), and environmental health (8 items), as well overall quality of life and general health (2 items). Patients express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). The final score is transformed linearly to a 0-100-scale, where higher scores denote higher quality of life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anxiety and depression assessment using HADS scale</measure>
      <time_frame>First examination- before the start of the interventions</time_frame>
      <description>The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anxiety and depression assessment using HADS scale</measure>
      <time_frame>Second examination- at the end of the 14-day rehabilitation program</time_frame>
      <description>The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anxiety and depression assessment using HADS scale</measure>
      <time_frame>Third examination - two months after discharge from the hospital (follow- up)</time_frame>
      <description>The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale</measure>
      <time_frame>First examination- before the start of the interventions</time_frame>
      <description>Life independence test, i.e. ensuring the functioning of the household by a sick person based on his/her ability to cope in the external environment or with a complex activity such as using the telephone and ensuring the related opportunities. The ability of basic functioning in the environment will be analyzed and each of 8 items will be rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The final total score ranges from 8 (low functioning, dependent) to 24 (high function, independent).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale</measure>
      <time_frame>Second examination- at the end of the 14-day rehabilitation program</time_frame>
      <description>Life independence test, i.e. ensuring the functioning of the household by a sick person based on his/her ability to cope in the external environment or with a complex activity such as using the telephone and ensuring the related opportunities. The ability of basic functioning in the environment will be analyzed and each of 8 items will be rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The final total score ranges from 8 (low functioning, dependent) to 24 (high function, independent).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale</measure>
      <time_frame>Third examination - two months after discharge from the hospital (follow- up)</time_frame>
      <description>Life independence test, i.e. ensuring the functioning of the household by a sick person based on his/her ability to cope in the external environment or with a complex activity such as using the telephone and ensuring the related opportunities. The ability of basic functioning in the environment will be analyzed and each of 8 items will be rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The final total score ranges from 8 (low functioning, dependent) to 24 (high function, independent).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Chronic Obstructive Pulmonary Disease</condition>
    <arm_group>
      <arm_group_label>Education program and Pulmonary rehabilitation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Conventional pulmonary rehabilitation coupled with original education program.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pulmonary rehabilitation</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Conventional pulmonary rehabilitation</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Education program</intervention_name>
      <description>Patients in a study group will participate in daily education program using an original brochure containing information on the benefits of appropriately adapted physical activity, practical tips on airway clearance techniques or physical exercise, and risk factors for exacerbation of COPD.</description>
      <arm_group_label>Education program and Pulmonary rehabilitation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pulmonary rehabilitation</intervention_name>
      <description>The patients will participate in a 14-day rehabilitation program (Monday to Saturday). Treatments and therapies will be continued for a maximum of two hours daily. The program will be applied individually to each patient and include active and assisted exercises, effective cough exercises, pursed-lips breathing, positive expiratory pressure exercises, exercises to strengthen the diaphragm and intercostal muscles and cardiopulmonary exercises.</description>
      <arm_group_label>Education program and Pulmonary rehabilitation</arm_group_label>
      <arm_group_label>Pulmonary rehabilitation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed chronic obstructive pulmonary disease in the exacerbation phase&#xD;
  &#xD;
            -  Moderate stage (II) of the disease&#xD;
  &#xD;
            -  Independence in basic activities of daily living (above 86 points on the Barthel&#xD;
               scale)&#xD;
  &#xD;
            -  Age 55 y.o. to 70 y.o.&#xD;
  &#xD;
            -  No additional respiratory support (e.a. cardiopulmonary bypass machine, ventilator)&#xD;
  &#xD;
            -  Informed, voluntary consent to participate in research.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed chronic obstructive pulmonary disease in remission&#xD;
  &#xD;
            -  Stages I, III and IV of the disease - a forms with mild, severe, and very severe&#xD;
               obstruction&#xD;
  &#xD;
            -  Hospitalization in the intensive care unit, current health condition precluding&#xD;
               participation in the study&#xD;
  &#xD;
            -  Age under 55 y.o. and over 70 y.o.&#xD;
  &#xD;
            -  Cognitive deficits impairing the ability to understand and execute commands&#xD;
  &#xD;
            -  Concomitant oncological, neurological, orthopedic, and psychiatric diseases may affect&#xD;
               the examined persons' circulatory and respiratory functions, functional efficiency,&#xD;
               quality of life, and emotional state.&#xD;
  &#xD;
            -  Failure to complete a 14-day rehabilitation program&#xD;
  &#xD;
            -  Lack of informed, voluntary consent to participate in research.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Renata Borys, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Rzeszów</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Agnieszka Guzik, A/Prof.</last_name>
      <role>Study Director</role>
      <affiliation>University of Rzeszów</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Magdalena Kołodziej, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Rzeszów</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Renata Borys, MSc</last_name>
      <phone>+48 784 016 220</phone>
      <email>rborys@ur.edu.pl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Magdalena Kołodziej, PhD</last_name>
      <phone>+ 48 794 244 063</phone>
      <email>mkolodziej@ur.edu.pl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Rzeszów</name>
        <address>
          <city>Rzeszów</city>
          <zip>35-959</zip>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Renata Borys, MSc</last_name>
        <phone>+48 784 016 220</phone>
        <email>rborys@ur.edu.pl</email>
      </contact>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Rzeszow</investigator_affiliation>
      <investigator_full_name>Renata Borys</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>pulmonary rehabilitation</keyword>
    <keyword>COPD patients' education</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT06028711
  org study id: URzeszow/2023/06/0034/W
  nct id: NCT06028711
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The planned research will enable the assessment of rehabilitation's effects using two
        pulmonary rehabilitation models: conventional and supplemented with an education program for
        patients hospitalized due to chronic obstructive pulmonary disease.
  The planned group size is 100 patients diagnosed with chronic obstructive pulmonary disease
        (COPD) and hospitalized due to exacerbation. The given population was calculated based on the
        sampling calculator, considering the following parameters: fraction size, confidence level,
        and maximum error.
  
        Eligible patients will be randomly divided into two groups: a study group (50 patients)
        undergoing pulmonary rehabilitation supplemented with an education program and a control
        group (50 patients) undergoing conventional pulmonary rehabilitation.
  
        Patients of both groups will be included in a 14-day rehabilitation program (Monday to
        Saturday). Treatments and therapies will be continued for a maximum of two hours daily. The
        program will be applied individually to each patient, including active and assisted
        exercises, effective cough exercises, pursed-lips breathing, positive expiratory pressure
        exercises, exercises to strengthen the diaphragm and intercostal muscles, and cardiopulmonary
        exercises. Patients from the study group will additionally undergo daily education using an
        original brochure containing information on the benefits of appropriately adapted physical
        activity, practical tips on airway clearance techniques or physical exercise, and risk
        factors for exacerbation of COPD.
  
        The test will be performed three times: before the start of rehabilitation, after completing
        the rehabilitation program, and the follow-up after two months from the end of
        hospitalization to assess long-term effects. After the end of the study, people from the
        control group will also undergo education.
  
        The patients' condition and the rehabilitation effects will be assessed using the following
        measures:
  
          -  Dynamic lung capacities (spirometry)
  
          -  Oxygen saturation and pulse rate (pulse oximeter)
  
          -  Acid-base balance (gasometry)
  
          -  Exercise tolerance (6-minute walking test)
  
          -  Fatigue (modified Borg scale)
  
          -  Physical performance (Fullerton functional fitness test)
  
          -  Dyspnea assessment (MRC dyspnea scale)
  
          -  Quality of life (WHOQOL-BREF)
  
          -  Anxiety and depression (HADS scale)
  
          -  Activities of daily living (Lawton IADL scale)
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: random selection to two groups (study group and control group)
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Dynamic lung capacities (spirometry)
  time frame: First examination- before the start of the interventions
  description: Measurements will be performed with certified spirometer and the parameters analyzed will be Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) measured in litres [L].
  measure: Dynamic lung capacities (spirometry)
  time frame: Second examination- at the end of the 14-day rehabilitation program
  description: Measurements will be performed with certified spirometer and the parameters analyzed will be Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) measured in litres [L].
  measure: Modified Tiffeneau-Pinelli index (spirometry)
  time frame: First examination- before the start of the interventions
  description: Measurement will be performed with certified spirometer and the parameter analyzed will be the ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC ratio) presented as a decimal fraction.
  measure: Modified Tiffeneau-Pinelli index (spirometry)
  time frame: Second examination- at the end of the 14-day rehabilitation program
  description: Measurement will be performed with certified spirometer and the parameter analyzed will be the ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC ratio) presented as a decimal fraction.
  measure: Oxygen saturation
  time frame: First examination- before the start of the interventions
  description: Measurements will be performed with pulse oximeter and the parameter analyzed will be oxygen saturation by pulse oximetry (SpO2, percentage of oxygen in patients' blood).
  measure: Oxygen saturation
  time frame: Second examination- at the end of the 14-day rehabilitation program
  description: Measurements will be performed with pulse oximeter and the parameter analyzed will be oxygen saturation by pulse oximetry (SpO2, percentage of oxygen in patients' blood).
  measure: Pulse rate
  time frame: First examination- before the start of the interventions
  description: Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.
  measure: Pulse rate
  time frame: Second examination- at the end of the 14-day rehabilitation program
  description: Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.
  measure: Acid-base balance
  time frame: First examination- before the start of the interventions
  description: The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).
  measure: Acid-base balance
  time frame: Second examination- at the end of the 14-day rehabilitation program
  description: The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).
  measure: Exercise tolerance assessed by 6-minute walking test (6MWT)
  time frame: First examination- before the start of the interventions
  description: The test will be performed in 20-meter long hospital corridor. The patient should walk the distance at his own rhythm and pace, using orthopedic aids (if necessary). The patient will be informed that they can stop the test at any time if they feel it is necessary. The distance traveled in meters in 6 minutes will be analyzed.
  measure: Exercise tolerance assessed by 6-minute walking test (6MWT)
  time frame: Second examination- at the end of the 14-day rehabilitation program
  description: The test will be performed in 20-meter long hospital corridor. The patient should walk the distance at his own rhythm and pace, using orthopedic aids (if necessary). The patient will be informed that they can stop the test at any time if they feel it is necessary. The distance traveled in meters in 6 minutes will be analyzed.
  measure: Physical performance assessment by Fullerton functional fitness test
  time frame: First examination- before the start of the interventions
  description: The test comprising muscle endurance, aerobic capacity, flexibility, agility, and balance assessment. The test consist of 6 activities: 1. Arm Curl Test (number of forearm flexions in 30 seconds); 2. Back Scratch (the distance between middle fingers); 3. 30 Second Chair Stand (number of standings in 30 seconds); 4. Chair Sit-and-Reach ( '+' if fingers can reach toes in sitting position, '-' if fingers cannot reach toes in sitting position); 5. 8 - Foot Up-and-Go (8-foot walking time); 6. 2-Minute Step-in-Place (the number of lifts of the right leg).
  measure: Physical performance assessment by Fullerton functional fitness test
  time frame: Second examination- at the end of the 14-day rehabilitation program
  description: The test comprising muscle endurance, aerobic capacity, flexibility, agility, and balance assessment. The test consist of 6 activities: 1. Arm Curl Test (number of forearm flexions in 30 seconds); 2. Back Scratch (the distance between middle fingers); 3. 30 Second Chair Stand (number of standings in 30 seconds); 4. Chair Sit-and-Reach ( '+' if fingers can reach toes in sitting position, '-' if fingers cannot reach toes in sitting position); 5. 8 - Foot Up-and-Go (8-foot walking time); 6. 2-Minute Step-in-Place (the number of lifts of the right leg).
  measure: Fatigue assessment using modified Borg scale
  time frame: First examination- before the start of the interventions
  description: Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).
  measure: Fatigue assessment using modified Borg scale
  time frame: Second examination- at the end of the 14-day rehabilitation program
  description: Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).
  measure: Fatigue assessment using modified Borg scale
  time frame: Third examination - two months after discharge from the hospital (follow- up)
  description: Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).
  measure: Dyspnea assessment with Medical Research Council dyspnea scale
  time frame: First examination- before the start of the interventions
  description: Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).
  measure: Dyspnea assessment with Medical Research Council dyspnea scale
  time frame: Second examination- at the end of the 14-day rehabilitation program
  description: Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).
  measure: Dyspnea assessment with Medical Research Council dyspnea scale
  time frame: Third examination - two months after discharge from the hospital (follow- up)
  description: Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).
  measure: Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
  time frame: First examination- before the start of the interventions
  description: Assessment of quality of life, health and other areas. The scale contains 26 items, divided into four domains: physical health (7 items), psychological health (6 items), social relations (3 items), and environmental health (8 items), as well overall quality of life and general health (2 items). Patients express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). The final score is transformed linearly to a 0-100-scale, where higher scores denote higher quality of life.
  measure: Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
  time frame: Second examination- at the end of the 14-day rehabilitation program
  description: Assessment of quality of life, health and other areas. The scale contains 26 items, divided into four domains: physical health (7 items), psychological health (6 items), social relations (3 items), and environmental health (8 items), as well overall quality of life and general health (2 items). Patients express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). The final score is transformed linearly to a 0-100-scale, where higher scores denote higher quality of life.
  measure: Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
  time frame: Third examination - two months after discharge from the hospital (follow- up)
  description: Assessment of quality of life, health and other areas. The scale contains 26 items, divided into four domains: physical health (7 items), psychological health (6 items), social relations (3 items), and environmental health (8 items), as well overall quality of life and general health (2 items). Patients express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). The final score is transformed linearly to a 0-100-scale, where higher scores denote higher quality of life.
  measure: Anxiety and depression assessment using HADS scale
  time frame: First examination- before the start of the interventions
  description: The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.
  measure: Anxiety and depression assessment using HADS scale
  time frame: Second examination- at the end of the 14-day rehabilitation program
  description: The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.
  measure: Anxiety and depression assessment using HADS scale
  time frame: Third examination - two months after discharge from the hospital (follow- up)
  description: The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.
  measure: Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale
  time frame: First examination- before the start of the interventions
  description: Life independence test, i.e. ensuring the functioning of the household by a sick person based on his/her ability to cope in the external environment or with a complex activity such as using the telephone and ensuring the related opportunities. The ability of basic functioning in the environment will be analyzed and each of 8 items will be rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The final total score ranges from 8 (low functioning, dependent) to 24 (high function, independent).
  measure: Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale
  time frame: Second examination- at the end of the 14-day rehabilitation program
  description: Life independence test, i.e. ensuring the functioning of the household by a sick person based on his/her ability to cope in the external environment or with a complex activity such as using the telephone and ensuring the related opportunities. The ability of basic functioning in the environment will be analyzed and each of 8 items will be rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The final total score ranges from 8 (low functioning, dependent) to 24 (high function, independent).
  measure: Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale
  time frame: Third examination - two months after discharge from the hospital (follow- up)
  description: Life independence test, i.e. ensuring the functioning of the household by a sick person based on his/her ability to cope in the external environment or with a complex activity such as using the telephone and ensuring the related opportunities. The ability of basic functioning in the environment will be analyzed and each of 8 items will be rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The final total score ranges from 8 (low functioning, dependent) to 24 (high function, independent).
  arm group label: Education program and Pulmonary rehabilitation
  arm group type: Experimental
  description: Conventional pulmonary rehabilitation coupled with original education program.
  arm group label: Pulmonary rehabilitation
  arm group type: Other
  description: Conventional pulmonary rehabilitation
  intervention type: Other
  intervention name: Education program
  description: Patients in a study group will participate in daily education program using an original brochure containing information on the benefits of appropriately adapted physical activity, practical tips on airway clearance techniques or physical exercise, and risk factors for exacerbation of COPD.
  arm group label: Education program and Pulmonary rehabilitation
  intervention type: Other
  intervention name: Pulmonary rehabilitation
  description: The patients will participate in a 14-day rehabilitation program (Monday to Saturday). Treatments and therapies will be continued for a maximum of two hours daily. The program will be applied individually to each patient and include active and assisted exercises, effective cough exercises, pursed-lips breathing, positive expiratory pressure exercises, exercises to strengthen the diaphragm and intercostal muscles and cardiopulmonary exercises.
  arm group label: Education program and Pulmonary rehabilitation
  arm group label: Pulmonary rehabilitation
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Renata Borys, MSc
  role: Principal Investigator
  affiliation: University of Rzeszów
  last name: Agnieszka Guzik, A/Prof.
  role: Study Director
  affiliation: University of Rzeszów
  last name: Magdalena Kołodziej, PhD
  role: Study Chair
  affiliation: University of Rzeszów
  last name: Renata Borys, MSc
  phone: +48 784 016 220
  email: rborys@ur.edu.pl
  last name: Magdalena Kołodziej, PhD
  phone: + 48 794 244 063
  email: mkolodziej@ur.edu.pl
  facility: 
  contact: 
  country: Poland
  responsible party type: Principal Investigator
  investigator affiliation: University of Rzeszow
  investigator full name: Renata Borys
  investigator title: Principal Investigator
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive