<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/NCT04460261</url>
  </required_header>
  <id_info>
    <org_study_id>20201987</org_study_id>
    <nct_id>NCT04460261</nct_id>
  </id_info>
  <brief_title>The Effects of 'Functional' Inspiratory Muscle Training</brief_title>
  <official_title>The Effects of a New Integrated Exercise Program Called 'Functional' Inspiratory Muscle Training in Geriatric Individuals With and Without Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ismail OZSOY</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ahi Evran University Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study was designed as a prospective and experimental study. Geriatric individuals (age ≥&#xD;
      65 years) with COPD and non-COPD were included in the study. Training program was identical&#xD;
      for both groups and consisted of 4 weeks of foundation IMT followed by 4 weeks of functional&#xD;
      IMT. Respiratory muscle strength, symptoms, exercise capacity, balance, postural control,&#xD;
      physical activity and quality of life were evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The incidence of chronic obstructive pulmonary disease (COPD), which is one of the most&#xD;
      important causes of worldwide mortality and morbidity, increases with age and the disease&#xD;
      worsens with the effects of aging. The effects of COPD are not only limited to the lungs, it&#xD;
      also affects other organs and systems, causing loss of strength in the respiratory muscles.&#xD;
      Respiratory muscles are the skeletal muscles that must maintain their continuous activities&#xD;
      for the continuity of life. Just like other skeletal muscles, the respiratory muscles can&#xD;
      also be trained based on the principles of exercise. Inspiratory muscle training (IMT) is an&#xD;
      exercise method used in both patients with COPD and the elderly population. Studies have&#xD;
      shown that IMT has positive effects in COPD and elderly individuals. However, in all these&#xD;
      studies IMT applications (also known as &quot;foundation or conventional IMT&quot;) focus only on the&#xD;
      respiratory task of the respiratory muscles. Nevertheless, in addition to their basic task of&#xD;
      respiration, respiratory muscles are also involved in core stabilization and postural&#xD;
      control.The aim of this study was to create an integrated IMT program for geriatric&#xD;
      individuals with and without COPD and investigate its effects.&#xD;
&#xD;
      The participants were divided into two groups as individuals with and without COPD. A total&#xD;
      of 8 weeks of IMT was applied for both groups using a threshold pressure loading device The&#xD;
      participants were asked to perform IMT twice a day in the morning and evening. Both groups&#xD;
      were trained 3 days a week under the supervision of a physiotherapist and other days of the&#xD;
      week without a supervisor. The treatment program consisted of 4 weeks of foundation IMT&#xD;
      followed by 4 weeks of functional IMT.The intensity of the exercise was adjusted to 40-50% of&#xD;
      the MIP. After 10 consecutive breathing cycles, the participants were asked to perform 3-4&#xD;
      breathe controls. As the tolerance increased, consecutive respiratory cycles were increased.&#xD;
      The intensity of MIP was adjusted by weekly MIP measurements. Currently, foundation IMT is&#xD;
      commonly used to train respiratory muscles. In the present study, foundation IMT was applied&#xD;
      during the first 4 weeks of training. The participants were asked to sit in a comfortable&#xD;
      upright position. Then the nose clip was placed, and the patients were instructed to tighten&#xD;
      their lips around the mouthpiece and breathe against the resistance. During this 4-week-long&#xD;
      training, all IMT applications were performed solely in a sitting position, without any&#xD;
      loading in other positions. Following the foundation IMT, all participants underwent four&#xD;
      weeks of functional IMT. Initially, all participants were taught diaphragmatic breathing and&#xD;
      activating abdominal wall musculature. Each training session started with warm-up exercises&#xD;
      and ended with cool-down exercises. During the loading phase, core stability, dynamic trunk&#xD;
      activation and postural control exercises were applied together with IMT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Actual">January 15, 2018</completion_date>
  <primary_completion_date type="Actual">January 15, 2018</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>
    <intervention_model_description>This study was designed as a prospective and experimental study. The participants were divided into two groups as geriatric individuals with and without chronic obstructive pulmonary disease (COPD). Both groups were trained 3 days a week under the supervision of a physiotherapist and other days of the week without a supervisor. The treatment program consisted of 4 weeks of foundation IMT followed by 4 weeks of functional IMT.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inspiratory muscle strength</measure>
    <time_frame>8 weeks</time_frame>
    <description>Inspiratory muscle strength (MIP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values &lt;10%) were performed and the highest value was recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expiratory muscle strength</measure>
    <time_frame>8 weeks</time_frame>
    <description>Expiratory muscle strength (MEP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values &lt;10%) were performed and the highest value was recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dyspnea assessment</measure>
    <time_frame>8 weeks</time_frame>
    <description>The Modified Medical Research Council (mMRC) Dyspnea Scale was used to evaluate dyspnea. Commonly used in the assessment of dyspnea in COPD, mMRC has a five-level scoring system ranging from 0 to 4. A high score indicates an increased sense of dyspnea.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptoms assessment</measure>
    <time_frame>8 weeks</time_frame>
    <description>The COPD Assessment Test (CAT) was used to assess symptoms in patients with COPD. It is a reliable test to evaluate the impact of COPD on a patient's health status. It has eight items and the score ranges from 0 to 40. Higher scores indicate increased symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Upper extremity functional exercise capacity assessment</measure>
    <time_frame>8 weeks</time_frame>
    <description>The 6-Minute Pegboard and Ring Test was used to assess upper extremity functional exercise capacity assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lower extremity functional exercise capacity assessment</measure>
    <time_frame>8 weeks</time_frame>
    <description>The 6-Minute Walking Test (6MWT) was used to assess lower extremity functional exercise capacity assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Balance assessment</measure>
    <time_frame>8 weeks</time_frame>
    <description>Balance was assessed using Berg Balance Scale (BBS). This scale consists of 14 items and each item is scored between 0 and 4. A higher score indicates better balance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static antero-posterior postural stability assessment</measure>
    <time_frame>8 weeks</time_frame>
    <description>A portable balance device (Biodex Biosway Portable Balance System, New York, USA) was used to measure static antero-posterior postural stability.A higher score indicates a lower level of postural control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static medio-lateral postural stability assessment</measure>
    <time_frame>8 weeks</time_frame>
    <description>A portable balance device (Biodex Biosway Portable Balance System, New York, USA) was used to measure static medio-lateral postural stability. A higher score indicates a lower level of postural control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity assessment</measure>
    <time_frame>8 weeks</time_frame>
    <description>Physical activity was assessed using the Physical Activity Scale for the Elderly (PASE). It is a validated 12-item self-administered scale in which higher scores indicate increased physical activity.The overall PASE score ranges from 0 to 400 or more and high scores show better physical activity levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment</measure>
    <time_frame>8 weeks</time_frame>
    <description>The quality of life was assessed using the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD). This questionnaire consists of 24 items in six different domains and higher scores indicate better quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>COPD Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with COPD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-COPD Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-COPD</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional Inspiratory Muscle Training</intervention_name>
    <description>Both groups were trained 3 days a week under the supervision of a physiotherapist and other days of the week without a supervisor. The treatment program consisted of 4 weeks of foundation IMT followed by 4 weeks of functional IMT. Foundation IMT was applied during the first 4 weeks of training. The participants were asked to sit in a comfortable upright position. Following the foundation IMT, all participants underwent four weeks of functional IMT. Initially, all participants were taught diaphragmatic breathing and activating abdominal wall musculature. Each training session started with warm-up exercises and ended with cool-down exercises. During the loading phase, core stability, dynamic trunk activation and postural control exercises were applied together with IMT.</description>
    <arm_group_label>COPD Group</arm_group_label>
    <arm_group_label>Non-COPD Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosing COPD in accordance with Global initiative for chronic obstructive pulmonary&#xD;
             disease (GOLD) guideline criteria&#xD;
&#xD;
          -  Being over 65 years old&#xD;
&#xD;
          -  Being a stable clinical condition (same medication routine for the past 3 weeks&#xD;
             without taking any antibiotics)&#xD;
&#xD;
          -  Independent mobilization&#xD;
&#xD;
          -  Note: Normal spirometry values set as the inclusion criteria for non-COPD group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Orthopaedic problems&#xD;
&#xD;
          -  Neurological problems&#xD;
&#xD;
          -  Cognitive problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ismail ozsoy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Selcuk University</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ahi Evran University Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ismail OZSOY</investigator_full_name>
    <investigator_title>İsmail ÖZSOY</investigator_title>
  </responsible_party>
  <keyword>chronic obstructive pulmonary disease</keyword>
  <keyword>functional inspiratory muscle training</keyword>
  <keyword>geriatric individuals</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</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/NCT04460261
org study id: 20201987
nct id: NCT04460261
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was designed as a prospective and experimental study. Geriatric individuals (age ≥
      65 years) with COPD and non-COPD were included in the study. Training program was identical
      for both groups and consisted of 4 weeks of foundation IMT followed by 4 weeks of functional
      IMT. Respiratory muscle strength, symptoms, exercise capacity, balance, postural control,
      physical activity and quality of life were evaluated.
The incidence of chronic obstructive pulmonary disease (COPD), which is one of the most
      important causes of worldwide mortality and morbidity, increases with age and the disease
      worsens with the effects of aging. The effects of COPD are not only limited to the lungs, it
      also affects other organs and systems, causing loss of strength in the respiratory muscles.
      Respiratory muscles are the skeletal muscles that must maintain their continuous activities
      for the continuity of life. Just like other skeletal muscles, the respiratory muscles can
      also be trained based on the principles of exercise. Inspiratory muscle training (IMT) is an
      exercise method used in both patients with COPD and the elderly population. Studies have
      shown that IMT has positive effects in COPD and elderly individuals. However, in all these
      studies IMT applications (also known as "foundation or conventional IMT") focus only on the
      respiratory task of the respiratory muscles. Nevertheless, in addition to their basic task of
      respiration, respiratory muscles are also involved in core stabilization and postural
      control.The aim of this study was to create an integrated IMT program for geriatric
      individuals with and without COPD and investigate its effects.

      The participants were divided into two groups as individuals with and without COPD. A total
      of 8 weeks of IMT was applied for both groups using a threshold pressure loading device The
      participants were asked to perform IMT twice a day in the morning and evening. Both groups
      were trained 3 days a week under the supervision of a physiotherapist and other days of the
      week without a supervisor. The treatment program consisted of 4 weeks of foundation IMT
      followed by 4 weeks of functional IMT.The intensity of the exercise was adjusted to 40-50% of
      the MIP. After 10 consecutive breathing cycles, the participants were asked to perform 3-4
      breathe controls. As the tolerance increased, consecutive respiratory cycles were increased.
      The intensity of MIP was adjusted by weekly MIP measurements. Currently, foundation IMT is
      commonly used to train respiratory muscles. In the present study, foundation IMT was applied
      during the first 4 weeks of training. The participants were asked to sit in a comfortable
      upright position. Then the nose clip was placed, and the patients were instructed to tighten
      their lips around the mouthpiece and breathe against the resistance. During this 4-week-long
      training, all IMT applications were performed solely in a sitting position, without any
      loading in other positions. Following the foundation IMT, all participants underwent four
      weeks of functional IMT. Initially, all participants were taught diaphragmatic breathing and
      activating abdominal wall musculature. Each training session started with warm-up exercises
      and ended with cool-down exercises. During the loading phase, core stability, dynamic trunk
      activation and postural control exercises were applied together with IMT.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This study was designed as a prospective and experimental study. The participants were divided into two groups as geriatric individuals with and without chronic obstructive pulmonary disease (COPD). Both groups were trained 3 days a week under the supervision of a physiotherapist and other days of the week without a supervisor. The treatment program consisted of 4 weeks of foundation IMT followed by 4 weeks of functional IMT.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Inspiratory muscle strength
time frame: 8 weeks
description: Inspiratory muscle strength (MIP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values <10%) were performed and the highest value was recorded.
measure: Expiratory muscle strength
time frame: 8 weeks
description: Expiratory muscle strength (MEP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values <10%) were performed and the highest value was recorded.
measure: Dyspnea assessment
time frame: 8 weeks
description: The Modified Medical Research Council (mMRC) Dyspnea Scale was used to evaluate dyspnea. Commonly used in the assessment of dyspnea in COPD, mMRC has a five-level scoring system ranging from 0 to 4. A high score indicates an increased sense of dyspnea.
measure: Symptoms assessment
time frame: 8 weeks
description: The COPD Assessment Test (CAT) was used to assess symptoms in patients with COPD. It is a reliable test to evaluate the impact of COPD on a patient's health status. It has eight items and the score ranges from 0 to 40. Higher scores indicate increased symptoms.
measure: Upper extremity functional exercise capacity assessment
time frame: 8 weeks
description: The 6-Minute Pegboard and Ring Test was used to assess upper extremity functional exercise capacity assessment
measure: Lower extremity functional exercise capacity assessment
time frame: 8 weeks
description: The 6-Minute Walking Test (6MWT) was used to assess lower extremity functional exercise capacity assessment.
measure: Balance assessment
time frame: 8 weeks
description: Balance was assessed using Berg Balance Scale (BBS). This scale consists of 14 items and each item is scored between 0 and 4. A higher score indicates better balance.
measure: Static antero-posterior postural stability assessment
time frame: 8 weeks
description: A portable balance device (Biodex Biosway Portable Balance System, New York, USA) was used to measure static antero-posterior postural stability.A higher score indicates a lower level of postural control.
measure: Static medio-lateral postural stability assessment
time frame: 8 weeks
description: A portable balance device (Biodex Biosway Portable Balance System, New York, USA) was used to measure static medio-lateral postural stability. A higher score indicates a lower level of postural control.
measure: Physical activity assessment
time frame: 8 weeks
description: Physical activity was assessed using the Physical Activity Scale for the Elderly (PASE). It is a validated 12-item self-administered scale in which higher scores indicate increased physical activity.The overall PASE score ranges from 0 to 400 or more and high scores show better physical activity levels.
measure: Quality of life assessment
time frame: 8 weeks
description: The quality of life was assessed using the World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD). This questionnaire consists of 24 items in six different domains and higher scores indicate better quality of life.
arm group label: COPD Group
arm group type: Experimental
description: Patients with COPD
arm group label: Non-COPD Group
arm group type: Experimental
description: Non-COPD
intervention type: Other
intervention name: Functional Inspiratory Muscle Training
description: Both groups were trained 3 days a week under the supervision of a physiotherapist and other days of the week without a supervisor. The treatment program consisted of 4 weeks of foundation IMT followed by 4 weeks of functional IMT. Foundation IMT was applied during the first 4 weeks of training. The participants were asked to sit in a comfortable upright position. Following the foundation IMT, all participants underwent four weeks of functional IMT. Initially, all participants were taught diaphragmatic breathing and activating abdominal wall musculature. Each training session started with warm-up exercises and ended with cool-down exercises. During the loading phase, core stability, dynamic trunk activation and postural control exercises were applied together with IMT.
arm group label: COPD Group
arm group label: Non-COPD Group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ismail ozsoy, PhD
role: Principal Investigator
affiliation: Selcuk University
responsible party type: Sponsor-Investigator
investigator affiliation: Ahi Evran University Education and Research Hospital
investigator full name: Ismail OZSOY
investigator title: İsmail ÖZSOY
mesh term: Respiratory Aspiration