<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/NCT03790410</url>
  </required_header>
  <id_info>
    <org_study_id>COPD IMT PC</org_study_id>
    <nct_id>NCT03790410</nct_id>
  </id_info>
  <brief_title>The Effect of Inspiratory Muscle Training on Postural Control in Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>The Effect of Inspiratory Muscle Training on Postural Control in Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Szeged University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Szeged 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>
      Deficits in postural control are increasingly recognized among the important secondary&#xD;
      impairments in patients with chronic obstructive pulmonary disease (COPD). There are&#xD;
      conflicting results regarding the effect of inspiratory muscle training in improvement of&#xD;
      inspiratory muscle strength, endurance, and dyspnea in stable COPD patients. The main&#xD;
      inspiratory muscle, the diaphragm has also a stabilizing function of the trunk. The aim of&#xD;
      this study to enhance postural control of COPD patients with improving the stability of the&#xD;
      trunk by using inspiratory muscle training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomized controlled trial in patients with stable COPD. The participants are&#xD;
      divided into two groups. Patients in the inspiratory muscle training (IMT) group take part in&#xD;
      a complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer&#xD;
      conditionings, relaxations, strength and endurance trainings completed by inspiratory muscle&#xD;
      training. The members of the IMT group use the POWERbreathe Medic device. The control group&#xD;
      perform the complex pulmonary rehabilitation program without IMT. The program is divided into&#xD;
      3 weeks inpatient period and 3 weeks home period. Before, between and after the 3 weeks&#xD;
      period all subjects are measured. 60 patients are planned to take part in the investigation.&#xD;
      The inspiratory muscle strength is measured by POWERbreathe K1 device. Balance is assessed by&#xD;
      functional balance tests: Timed Up and Go Test, Four Square Step Test, Modified Functional&#xD;
      Reach Test, Modified Lateral Reach Test, Stand Up Test. Body Sway is measured by HR Mat&#xD;
      VersaTek System. The diameter of the diaphragm muscle is assessed by B-mode ultrasound&#xD;
      examination using Zonare Z. One Ultrasound System. Arterial stiffness parameters measured by&#xD;
      Arteriograph.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal Inspiratory Pressure</measure>
    <time_frame>6 weeks</time_frame>
    <description>The inspiratory pressure generated against a completely occluded airway; used to evaluate inspiratory respiratory muscle strength and readiness for weaning from A maximum inspiratory pressure is measured in H2Ocm. MIP is measured with POWERbreathe K1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed Up and Go Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>Timed Up and Go: It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Four Square Step Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>Four Square Step Test:&#xD;
The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The aim is to step as fast as possible into each square with both feet.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Functional Reach Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>Modified Functional Reach Test:&#xD;
The MFRT assesses a patient's stability by measuring the maximum distance an individual can reach forward while sitting in a fixed position.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Lateral Reach Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>Modified Lateral Reach Test:&#xD;
The MLRT assesses a patient's stability by measuring the maximum distance an individual can reach side direction while sitting in a fixed position.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stand Up Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>Stand Up Test:&#xD;
Individual stand up from tailor sit from the floor as fast as possible.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sway analysis: COF area (cm2)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sway analysis: COF distance (cm)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sway analysis: COF variability (cm)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sway analysis: COF A-P excursion (cm)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sway analysis: COF L-R excursion (cm)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thickness of the diaphragm muscle's belly</measure>
    <time_frame>6 weeks</time_frame>
    <description>The diameter of the diaphragm muscle is assessed by B-mode ultrasound examination using Zonare Z. One Ultrasound System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vibration Sense Testing</measure>
    <time_frame>6 weeks</time_frame>
    <description>Tuning fork is used to evaluate the deep sensation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse wave velocity</measure>
    <time_frame>6 weeks</time_frame>
    <description>Pulse wave velocity is measured with Arteriograph.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Augmentation index</measure>
    <time_frame>6 weeks</time_frame>
    <description>Augmentation index is measured with Arteriograph</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>COPD Postural Control IMT</condition>
  <arm_group>
    <arm_group_label>Control group-Complex pulmonary rehab.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Complex pulmonary rehabilitation:&#xD;
The complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inspiratory muscle training group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Complex pulmonary rehabilitation:&#xD;
The complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.&#xD;
Inspiratory muscle training&#xD;
The training program contains strengthening exercises on the diaphragm muscle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Complex pulmonary rehabilitation</intervention_name>
    <description>Complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.</description>
    <arm_group_label>Control group-Complex pulmonary rehab.</arm_group_label>
    <arm_group_label>Inspiratory muscle training group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inspiratory muscle training</intervention_name>
    <description>The training program contains strengthening exercises on the diaphragm muscle.</description>
    <arm_group_label>Inspiratory muscle training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable COPD&#xD;
&#xD;
          -  Do not take part in other treatment&#xD;
&#xD;
          -  Be able to learn the usage of inspiratory muscle trainer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute exacerbation&#xD;
&#xD;
          -  Balance problems with neurological cause&#xD;
&#xD;
          -  The patient unable to cooperate&#xD;
&#xD;
          -  Participation in pulmonary rehabilitation 3 months before the study&#xD;
&#xD;
          -  IMT use in the 3 months before the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Szeged</name>
      <address>
        <city>Szeged</city>
        <state>Csongrád</state>
        <zip>6726</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>October 30, 2020</last_update_submitted>
  <last_update_submitted_qc>October 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Szeged University</investigator_affiliation>
    <investigator_full_name>Levente Szilagyi</investigator_full_name>
    <investigator_title>University Lecturer</investigator_title>
  </responsible_party>
  <keyword>COPD Postural Control IMT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>


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/NCT03790410
org study id: COPD IMT PC
nct id: NCT03790410
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Deficits in postural control are increasingly recognized among the important secondary
      impairments in patients with chronic obstructive pulmonary disease (COPD). There are
      conflicting results regarding the effect of inspiratory muscle training in improvement of
      inspiratory muscle strength, endurance, and dyspnea in stable COPD patients. The main
      inspiratory muscle, the diaphragm has also a stabilizing function of the trunk. The aim of
      this study to enhance postural control of COPD patients with improving the stability of the
      trunk by using inspiratory muscle training.
The study is a randomized controlled trial in patients with stable COPD. The participants are
      divided into two groups. Patients in the inspiratory muscle training (IMT) group take part in
      a complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer
      conditionings, relaxations, strength and endurance trainings completed by inspiratory muscle
      training. The members of the IMT group use the POWERbreathe Medic device. The control group
      perform the complex pulmonary rehabilitation program without IMT. The program is divided into
      3 weeks inpatient period and 3 weeks home period. Before, between and after the 3 weeks
      period all subjects are measured. 60 patients are planned to take part in the investigation.
      The inspiratory muscle strength is measured by POWERbreathe K1 device. Balance is assessed by
      functional balance tests: Timed Up and Go Test, Four Square Step Test, Modified Functional
      Reach Test, Modified Lateral Reach Test, Stand Up Test. Body Sway is measured by HR Mat
      VersaTek System. The diameter of the diaphragm muscle is assessed by B-mode ultrasound
      examination using Zonare Z. One Ultrasound System. Arterial stiffness parameters measured by
      Arteriograph.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Maximal Inspiratory Pressure
time frame: 6 weeks
description: The inspiratory pressure generated against a completely occluded airway; used to evaluate inspiratory respiratory muscle strength and readiness for weaning from A maximum inspiratory pressure is measured in H2Ocm. MIP is measured with POWERbreathe K1
measure: Timed Up and Go Test
time frame: 6 weeks
description: Timed Up and Go: It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
measure: Four Square Step Test
time frame: 6 weeks
description: Four Square Step Test:
The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The aim is to step as fast as possible into each square with both feet.
measure: Modified Functional Reach Test
time frame: 6 weeks
description: Modified Functional Reach Test:
The MFRT assesses a patient's stability by measuring the maximum distance an individual can reach forward while sitting in a fixed position.
measure: Modified Lateral Reach Test
time frame: 6 weeks
description: Modified Lateral Reach Test:
The MLRT assesses a patient's stability by measuring the maximum distance an individual can reach side direction while sitting in a fixed position.
measure: Stand Up Test
time frame: 6 weeks
description: Stand Up Test:
Individual stand up from tailor sit from the floor as fast as possible.
measure: Sway analysis: COF area (cm2)
time frame: 6 weeks
description: Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.
measure: Sway analysis: COF distance (cm)
time frame: 6 weeks
description: Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.
measure: Sway analysis: COF variability (cm)
time frame: 6 weeks
description: Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.
measure: Sway analysis: COF A-P excursion (cm)
time frame: 6 weeks
description: Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.
measure: Sway analysis: COF L-R excursion (cm)
time frame: 6 weeks
description: Sway is the oscillating movement of the body, while posture is the relative alignment and orientation of the segments of the body. Sway analysis is a systematic assessment of the readiness and stability of the human body to achieve and maintain equilibrium. Area and direction of sway, elliptical pattern of sway, distance and direction traveled by Center of Force (CoF) is measured with HR Mat VersaTek System.
measure: Thickness of the diaphragm muscle's belly
time frame: 6 weeks
description: The diameter of the diaphragm muscle is assessed by B-mode ultrasound examination using Zonare Z. One Ultrasound System.
measure: Vibration Sense Testing
time frame: 6 weeks
description: Tuning fork is used to evaluate the deep sensation.
measure: Pulse wave velocity
time frame: 6 weeks
description: Pulse wave velocity is measured with Arteriograph.
measure: Augmentation index
time frame: 6 weeks
description: Augmentation index is measured with Arteriograph
arm group label: Control group-Complex pulmonary rehab.
arm group type: Active Comparator
description: Complex pulmonary rehabilitation:
The complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.
arm group label: Inspiratory muscle training group
arm group type: Active Comparator
description: Complex pulmonary rehabilitation:
The complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.
Inspiratory muscle training
The training program contains strengthening exercises on the diaphragm muscle.
intervention type: Other
intervention name: Complex pulmonary rehabilitation
description: Complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.
arm group label: Control group-Complex pulmonary rehab.
arm group label: Inspiratory muscle training group
intervention type: Other
intervention name: Inspiratory muscle training
description: The training program contains strengthening exercises on the diaphragm muscle.
arm group label: Inspiratory muscle training group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Hungary
responsible party type: Principal Investigator
investigator affiliation: Szeged University
investigator full name: Levente Szilagyi
investigator title: University Lecturer
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive