<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/NCT02257463</url>
  </required_header>
  <id_info>
    <org_study_id>MD/4</org_study_id>
    <nct_id>NCT02257463</nct_id>
  </id_info>
  <brief_title>Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to study effectiveness of inspiratory muscle training as a part of exercise&#xD;
      training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to&#xD;
      general exercise training program in regard to respiratory muscle strength, dyspnea, exercise&#xD;
      performance and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in respiratory muscle strength</measure>
    <time_frame>after 4 weeks and after 8 weeks of study</time_frame>
    <description>maximal inspiratory pressure, maximal expiratory pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes in perception of dyspnea</measure>
    <time_frame>after 4 weeks and after 8 weeks of study</time_frame>
    <description>modified Medical Research Council and modified Borg category scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes in exercise performance</measure>
    <time_frame>after 4 weeks and after 8 weeks of study</time_frame>
    <description>6-min walk test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes in quality of life</measure>
    <time_frame>after 4 weeks and after 8 weeks of study</time_frame>
    <description>BODE index, St. George's Respiratory Questionnaire for COPD patients (SGRQ-C)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Study group (group A)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>pharmacologic treatment: theophylline &quot;uniphyllin&quot;, long acting bronchodilators &quot;foradil/spiriva&quot; or combined LABD and inhaled steroids &quot;miflonide&quot; according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training) inspiratory muscle training: (at intensity that progressively increased from 30% to 60% of patients' maximal inspiratory pressure)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control positive group (group B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>pharmacologic treatment: theophylline &quot;uniphyllin&quot;, long acting bronchodilators &quot;foradil/spiriva&quot; or combined LABD and inhaled steroids &quot;miflonide&quot; according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control negative group (group C)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>pharmacologic treatment: theophylline &quot;uniphyllin&quot;, long acting bronchodilators &quot;foradil/spiriva&quot; or combined LABD and inhaled steroids &quot;miflonide&quot; according to GOLD recommendations</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations</intervention_name>
    <arm_group_label>Study group (group A)</arm_group_label>
    <arm_group_label>control negative group (group C)</arm_group_label>
    <arm_group_label>control positive group (group B)</arm_group_label>
    <other_name>uniphyllin, foradil, spiriva, miflonide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>peripheral muscles exercise training</intervention_name>
    <arm_group_label>Study group (group A)</arm_group_label>
    <arm_group_label>control positive group (group B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>inspiratory muscle training</intervention_name>
    <description>Patients started breathing at a resistance that required generation of 30% of their PImax for one week. The load was then increased incrementally, 5-10%, to reach generation of 60% of their PImax at the end of the first month. Specific IMT was then continued at 60% of their PImax adjusted weekly to the new PImax achieved.</description>
    <arm_group_label>Study group (group A)</arm_group_label>
    <other_name>Threshold® Inspiratory Muscle Trainer, Healthscan, New Jersey, NJ, USA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Exsmokers&#xD;
&#xD;
          -  Low PImax compared to reference values [lower limits of normal: 80 cmH2O for patients&#xD;
             less than or equal 54 years old; 71 cmH2O for patients' age between 55-64 years; and&#xD;
             65 cmH2O for patients 65 years old ].&#xD;
&#xD;
          -  Stable patients without history of exacerbation or hospitalization four weeks before&#xD;
             starting the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of motivation and compliance.&#xD;
&#xD;
          -  Patients with significant reversibility following bronchodilation defined as an&#xD;
             increase in FEV1 of more than 12% and 200 ml from the pre-bronchodilator value&#xD;
&#xD;
          -  Unstable cardiac disease [severe heart failure, dangerous dysrhythmias, recent&#xD;
             myocardial infarction or unstable angina (within 4 weeks)].&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Recent pneumothorax (within 6 weeks)&#xD;
&#xD;
          -  Recent abdominal or thoracic surgery (within 6 weeks)&#xD;
&#xD;
          -  Known progressive neuromuscular disorders&#xD;
&#xD;
          -  Recent gastrointestinal bleeding (within 4 weeks)&#xD;
&#xD;
          -  Current smokers&#xD;
&#xD;
          -  Active cancer&#xD;
&#xD;
          -  Patients with advanced liver diseases, or renal impairment.&#xD;
&#xD;
          -  Known connective tissue diseases&#xD;
&#xD;
          -  Significant endocrinal abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed S Elmorsi, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamad E Eldesoky, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mona AA Mohsen, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nesrien M Shalaby, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dina A Abdallah, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>April 7, 2015</last_update_submitted>
  <last_update_submitted_qc>April 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Dina Aboelkhair Abdallah</investigator_full_name>
    <investigator_title>assistant lecturer in chest medicine</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>inspiratory muscle training</keyword>
  <keyword>dyspnea</keyword>
  <keyword>Quality of Life</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>
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Theophylline</mesh_term>
    <mesh_term>Bronchodilator Agents</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02257463
org study id: MD/4
nct id: NCT02257463
lead sponsor: 
has dmc: Yes
The aim is to study effectiveness of inspiratory muscle training as a part of exercise
      training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to
      general exercise training program in regard to respiratory muscle strength, dyspnea, exercise
      performance and quality of life.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: changes in respiratory muscle strength
time frame: after 4 weeks and after 8 weeks of study
description: maximal inspiratory pressure, maximal expiratory pressure
measure: changes in perception of dyspnea
time frame: after 4 weeks and after 8 weeks of study
description: modified Medical Research Council and modified Borg category scale
measure: changes in exercise performance
time frame: after 4 weeks and after 8 weeks of study
description: 6-min walk test
measure: changes in quality of life
time frame: after 4 weeks and after 8 weeks of study
description: BODE index, St. George's Respiratory Questionnaire for COPD patients (SGRQ-C)
arm group label: Study group (group A)
arm group type: Active Comparator
description: pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training) inspiratory muscle training: (at intensity that progressively increased from 30% to 60% of patients' maximal inspiratory pressure)
arm group label: control positive group (group B)
arm group type: Active Comparator
description: pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training)
arm group label: control negative group (group C)
arm group type: Active Comparator
description: pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations
intervention type: Drug
intervention name: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations
arm group label: Study group (group A)
arm group label: control negative group (group C)
arm group label: control positive group (group B)
other name: uniphyllin, foradil, spiriva, miflonide
intervention type: Other
intervention name: peripheral muscles exercise training
arm group label: Study group (group A)
arm group label: control positive group (group B)
intervention type: Device
intervention name: inspiratory muscle training
description: Patients started breathing at a resistance that required generation of 30% of their PImax for one week. The load was then increased incrementally, 5-10%, to reach generation of 60% of their PImax at the end of the first month. Specific IMT was then continued at 60% of their PImax adjusted weekly to the new PImax achieved.
arm group label: Study group (group A)
other name: Threshold® Inspiratory Muscle Trainer, Healthscan, New Jersey, NJ, USA
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ahmed S Elmorsi, MD
role: Study Chair
affiliation: Mansoura University
last name: Mohamad E Eldesoky, MD
role: Study Director
affiliation: Mansoura University
last name: Mona AA Mohsen, MD
role: Study Director
affiliation: Mansoura University
last name: Nesrien M Shalaby, MD
role: Study Director
affiliation: Mansoura University
last name: Dina A Abdallah, MSc
role: Principal Investigator
affiliation: Mansoura University
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Dina Aboelkhair Abdallah
investigator title: assistant lecturer in chest medicine
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Respiratory Aspiration
mesh term: Theophylline
mesh term: Bronchodilator Agents