<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/NCT02200549</url>
  </required_header>
  <id_info>
    <org_study_id>CX13902205193</org_study_id>
    <nct_id>NCT02200549</nct_id>
  </id_info>
  <brief_title>Effects of Combined Cycle Training and Inspiratory Muscle Training in Patients With COPD</brief_title>
  <official_title>Effects of Combined Cycle Training and Inspiratory Muscle Training on Exercise Performance ,Health-related Quality,Dyspnoea ,Body Composition,Depressive Symptomatology in Patients With Chronic Obstructive Pulmonary Disease(COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhujiang Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic Obstructive Pulmonary Disease (COPD) ，the fourth leading cause of death in the world,&#xD;
      represents an important public health challenge. It is also a major cause of chronic&#xD;
      morbidity, mortality and disability throughout the world, leading to a heavy social and&#xD;
      economic burden. For a long time, treatment of COPD mainly focus on drug therapy. Recently,&#xD;
      pulmonary rehabilitation is recognized as a core component of the management of individuals&#xD;
      with chronic respiratory disease, which has been clearly demonstrated to reduce dyspnea,&#xD;
      increase exercise capacity, and improve quality of life.&#xD;
&#xD;
      Exercise training, widely regarded as the cornerstone of pulmonary rehabilitation , is one of&#xD;
      the best available means of improving muscle function in COPD.The most commonly form is cycle&#xD;
      training. Inspiratory Muscle Training (IMT) as an adjunct to exercise training has an&#xD;
      additional benefit on inspiratory muscle strength, endurance and exercise capacity in patient&#xD;
      with COPD.&#xD;
&#xD;
      There is insufficient evidence demonstrate greater benefits from combined inspiratory muscle&#xD;
      training and cycle training. This study will evaluate the effects of combined inspiratory&#xD;
      muscle training and cycle training in patients with COPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients with COPD will participate in a rehabilitation program for 8 weeks. Participants&#xD;
      in the proposed study will be randomly programmed into one of three intervention groups:&#xD;
&#xD;
        1. Cycle training program alone (performing on calibrated stationary cycle ergometer).&#xD;
&#xD;
        2. Combined cycle training and inspiratory muscle training(performing on calibrated&#xD;
           stationary cycle ergometer and threshold loading device).&#xD;
&#xD;
        3. Neither cycle training nor inspiratory muscle training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exercise Performance (composite outcome measure)</measure>
    <time_frame>The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)</time_frame>
    <description>Exercise performance tests include field walking tests and cycle ergometer tests.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health-related quality (composite outcome measure)</measure>
    <time_frame>The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)</time_frame>
    <description>Health-related quality is a component of the broader concept of quality of life and is defined as satisfaction with health.The St. George's Respiratory Questionnaire (SGRQ) and Chronic Respiratory Disease Questionnaire (CRQ）; and its self-reported version are the most widely used disease-specific questionnaires.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inspiratory muscle function (composite outcome measure)</measure>
    <time_frame>The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)</time_frame>
    <description>Currently, a variety of methods can be used to evaluate respiratory muscle function, including maximal inspiratory (PImax)，expiratory pressures(PEmax) and inspiratory muscle endurance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Evaluation (composite outcome measure)</measure>
    <time_frame>The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)</time_frame>
    <description>Individuals with chronic respiratory disease often have symptoms such as dyspnea, fatigue, cough, weakness, sleeplessness,and psychological distress.Instruments for assessment of multiple symptoms include COPD Assessment Test (CAT) and Modified Medical British Research Council Scale(mMRC).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Depression and anxiety evaluation</measure>
    <time_frame>The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS) was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression in both somatic, psychiatric and primary care patients and in the general population.</description>
  </other_outcome>
  <other_outcome>
    <measure>Composite outcomes</measure>
    <time_frame>The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)</time_frame>
    <description>Among patients with COPD there is increasing interest in the use of multidimensional indices to characterize the severity of the disease and better predict outcomes.Arguably the most well-known of these indices is the BODE Index.</description>
  </other_outcome>
  <other_outcome>
    <measure>Body Composition Monitor</measure>
    <time_frame>The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)</time_frame>
    <description>Body composition abnormalities are prevalent in COPD.Human body composition analyzer can detect various elements of human body and analyze human health status.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neither cycle training nor inspiratory muscle training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cycle training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 30-minute Combined training session is performed 3 days a week using calibrated cycle ergometer and threshold loading device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Neither cycle training nor inspiratory muscle training.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>calibrated cycle ergometer</intervention_name>
    <description>The most common device to proform cycle training is calibrated cycle ergometer.</description>
    <arm_group_label>Cycle training group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>calibrated cycle ergometer and threshold loading device</intervention_name>
    <description>Combined cycle training and inspiratory muscle training.The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.</description>
    <arm_group_label>Combined group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between 40 and 75 years of age were eligible if they met the following&#xD;
             criteria:&#xD;
&#xD;
               -  moderate to severe airflow obstruction (30≤ Forced Expiratory Volume At One&#xD;
                  Second(FEV1) &lt;80% predicted and Forced Expiratory Volume At One Second/Forced&#xD;
                  Vital Capacity(FEV1/FVC)&lt;70%)&#xD;
&#xD;
               -  Complaints of dyspnea on exertion&#xD;
&#xD;
               -  Clinically stable condition&#xD;
&#xD;
               -  No participation in a pulmonary rehabilitation program in the last year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients were excluded if they had evidence of asthma and/or had experienced a major&#xD;
             exacerbation in the 2 months before enrollment&#xD;
&#xD;
          -  Required home oxygen therapy or experienced oxyhemoglobin desaturation below 85% with&#xD;
             exercise&#xD;
&#xD;
          -  And/or had other health problems that would interfere with exercise.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xin Chen, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhujiang Hospital,Southern Medical Unversity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhujiang Hospital,Southern Medical Universtiy</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510282</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>July 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>May 16, 2017</last_update_submitted>
  <last_update_submitted_qc>May 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pulmonary rehabilitation</keyword>
  <keyword>inspiratory muscle training</keyword>
  <keyword>exercise training</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02200549
org study id: CX13902205193
nct id: NCT02200549
lead sponsor: 
has dmc: Yes
Chronic Obstructive Pulmonary Disease (COPD) ，the fourth leading cause of death in the world,
      represents an important public health challenge. It is also a major cause of chronic
      morbidity, mortality and disability throughout the world, leading to a heavy social and
      economic burden. For a long time, treatment of COPD mainly focus on drug therapy. Recently,
      pulmonary rehabilitation is recognized as a core component of the management of individuals
      with chronic respiratory disease, which has been clearly demonstrated to reduce dyspnea,
      increase exercise capacity, and improve quality of life.

      Exercise training, widely regarded as the cornerstone of pulmonary rehabilitation , is one of
      the best available means of improving muscle function in COPD.The most commonly form is cycle
      training. Inspiratory Muscle Training (IMT) as an adjunct to exercise training has an
      additional benefit on inspiratory muscle strength, endurance and exercise capacity in patient
      with COPD.

      There is insufficient evidence demonstrate greater benefits from combined inspiratory muscle
      training and cycle training. This study will evaluate the effects of combined inspiratory
      muscle training and cycle training in patients with COPD.
The patients with COPD will participate in a rehabilitation program for 8 weeks. Participants
      in the proposed study will be randomly programmed into one of three intervention groups:

        1. Cycle training program alone (performing on calibrated stationary cycle ergometer).

        2. Combined cycle training and inspiratory muscle training(performing on calibrated
           stationary cycle ergometer and threshold loading device).

        3. Neither cycle training nor inspiratory muscle training.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Exercise Performance (composite outcome measure)
time frame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
description: Exercise performance tests include field walking tests and cycle ergometer tests.
measure: Health-related quality (composite outcome measure)
time frame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
description: Health-related quality is a component of the broader concept of quality of life and is defined as satisfaction with health.The St. George's Respiratory Questionnaire (SGRQ) and Chronic Respiratory Disease Questionnaire (CRQ）; and its self-reported version are the most widely used disease-specific questionnaires.
measure: inspiratory muscle function (composite outcome measure)
time frame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
description: Currently, a variety of methods can be used to evaluate respiratory muscle function, including maximal inspiratory (PImax)，expiratory pressures(PEmax) and inspiratory muscle endurance.
measure: Symptom Evaluation (composite outcome measure)
time frame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
description: Individuals with chronic respiratory disease often have symptoms such as dyspnea, fatigue, cough, weakness, sleeplessness,and psychological distress.Instruments for assessment of multiple symptoms include COPD Assessment Test (CAT) and Modified Medical British Research Council Scale(mMRC).
measure: Depression and anxiety evaluation
time frame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
description: Hospital Anxiety and Depression Scale (HADS) was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression in both somatic, psychiatric and primary care patients and in the general population.
measure: Composite outcomes
time frame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
description: Among patients with COPD there is increasing interest in the use of multidimensional indices to characterize the severity of the disease and better predict outcomes.Arguably the most well-known of these indices is the BODE Index.
measure: Body Composition Monitor
time frame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
description: Body composition abnormalities are prevalent in COPD.Human body composition analyzer can detect various elements of human body and analyze human health status.
arm group label: Control group
arm group type: Experimental
description: Neither cycle training nor inspiratory muscle training.
arm group label: Cycle training group
arm group type: Experimental
description: A 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer.
arm group label: Combined group
arm group type: Experimental
description: A 30-minute Combined training session is performed 3 days a week using calibrated cycle ergometer and threshold loading device.
intervention type: Device
intervention name: Control group
description: Neither cycle training nor inspiratory muscle training.
arm group label: Control group
intervention type: Device
intervention name: calibrated cycle ergometer
description: The most common device to proform cycle training is calibrated cycle ergometer.
arm group label: Cycle training group
intervention type: Device
intervention name: calibrated cycle ergometer and threshold loading device
description: Combined cycle training and inspiratory muscle training.The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.
arm group label: Combined group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xin Chen, Doctor
role: Principal Investigator
affiliation: Zhujiang Hospital,Southern Medical Unversity
facility: 
country: China
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Respiratory Aspiration
sharing ipd: No