<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/NCT03827356</url>
  </required_header>
  <id_info>
    <org_study_id>27112018</org_study_id>
    <nct_id>NCT03827356</nct_id>
  </id_info>
  <brief_title>&quot;Inspiratory Muscle Training in Older Women&quot;</brief_title>
  <official_title>&quot;Comparison Between Two Programs of Inspiratory Muscle Training, Low Resistance vs High Resistance, in Institutionalized Older Women&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Salamanca</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Salamanca</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>
      Objective: To evaluate the effectiveness of two protocols of inspiratory muscle training&#xD;
      (IMT) in older women to improve respiratory strength, spirometric parameters and dyspnea.&#xD;
      Low-intensity vs high-intensity resistance training programs. Evaluations: Determination of&#xD;
      the maximum inspiratory pressure (MIP) and the maximum expiratory pressure (MEP); spirometry&#xD;
      - maximum voluntary ventilation (MVV), peak expiratory flow (PEF), tidal volume (TV);&#xD;
      functional capacity measured with 6 minute walk test; dyspnea using the Borg scale and&#xD;
      clinical evaluations. The participants will be evaluated at the beginning and end of the&#xD;
      intervention period. Intervention: There are two groups of patients, one works with low loads&#xD;
      (20% MIP) and another with high loads (40% MIP). They train 5 days/week 15 cycles lasting 1&#xD;
      minute. There is a rest of 1 minute between each cycle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants:&#xD;
&#xD;
      Institutionalized women will be recruited to participate in an 8-week randomized trial.&#xD;
&#xD;
      All patients will be asked to carry out the 5-day weekly program, and a recording sheet will&#xD;
      be provided to each participant so they will can record the time of each daily respiratory&#xD;
      training session. All participants signed an informed consent form.&#xD;
&#xD;
      The patients will be assigned to the two groups randomly. The main researcher doesn´t meet&#xD;
      any of the participants until the initial assessment will be carried out.&#xD;
&#xD;
      Evaluation:&#xD;
&#xD;
      The participants are evaluated at the beginning and end of the intervention period.&#xD;
&#xD;
      The evaluation of MIP and MEP is performed using a pressure transducer, Elka 15, which&#xD;
      obtains each measurement in millibar and converts it into the reference unit of centimeter of&#xD;
      water (cm H2O) (1 mbar = 1.01973 cm H2O .), following the rules of the American thoracic&#xD;
      society/European respiratory society (ATS / ERS). The procedure will be repeated until 3&#xD;
      values were obtained with a difference of less than 5%, and the highest value will be used&#xD;
      for the analysis. The MIP of the intervention group will be assessed every 2 weeks to set the&#xD;
      IMT workload.&#xD;
&#xD;
      Lung volumes are assessed using a spirometer (model: datospir touch) with a turbine&#xD;
      transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules will&#xD;
      be followed [19], and the highest value of three correct measurements will be chosen. Data is&#xD;
      collected for the following parameters: maximum voluntary ventilation (MVV), forced&#xD;
      expiratory volume in the first second (FEV1), peak expiratory flow (PEF), mean expiratory&#xD;
      flow (FEF25-75), vital capacity (VC), tidal volume (TV) and forced vital capacity (FVC).&#xD;
&#xD;
      Dyspnea will be measured using the modified Borg scale [20]. Functional capacity will be&#xD;
      measured with 6 minute walk test. All evaluations will be done in the corresponding center,&#xD;
      during the same time slot and by the same examiner for both groups.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      &quot;High-intensity group&quot;. The device incorporates a unidirectional valve independent of flow to&#xD;
      guarantee constant resistance and includes a specific pressure setting (in cm H2O).&#xD;
&#xD;
      The intensity of the device will be 40% of MIP. The protocol includes 15 cycles lasting 1&#xD;
      minute, twice a day: one in the morning and one in the afternoon. The participants rest for 1&#xD;
      minute between each cycle. In total, the protocol includes 30 minutes of daily respiratory&#xD;
      training. The patients will be instructed to inhale with enough force to reach the opening of&#xD;
      the valve.&#xD;
&#xD;
      &quot;Low-intensity group&quot;.The device incorporates a unidirectional valve independent of flow to&#xD;
      guarantee constant resistance and includes a specific pressure setting (in cm H2O).&#xD;
&#xD;
      The intensity of the device will be 20% of MIP. The protocol includes 15 cycles lasting 1&#xD;
      minute, twice a day: one in the morning and one in the afternoon. The participants rest for 1&#xD;
      minute between each cycle. In total, the protocol includes 30 minutes of daily respiratory&#xD;
      training. The patients will be instructed to inhale with enough force to reach the opening of&#xD;
      the valve.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2019</start_date>
  <completion_date type="Actual">September 10, 2019</completion_date>
  <primary_completion_date type="Actual">June 10, 2019</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>Patients are assigned randomly to the 2 working groups, each patient only receives one of the two protocols.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The principal investigator doesn´t know the group of the patients until the study ends</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal inspiratory pressure (MIP)</measure>
    <time_frame>2 minutes</time_frame>
    <description>The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the American Thoracic Society/European Respiratory Society (ATS / ERS). The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis. The MIP of the intervention group was assessed every 2 weeks to set the IMT workload.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal expiratory pressure (MEP)</measure>
    <time_frame>2 minutes</time_frame>
    <description>The evaluation is performed using a pressure transducer, Elka 15. It is evaluated at the beginning and at the end of the interventional phase.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum voluntary ventilation (MVV)</measure>
    <time_frame>1 minute</time_frame>
    <description>Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: Liter (L)/Minute (min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced expiratory volume in the first second (FEV1)</measure>
    <time_frame>1 minute</time_frame>
    <description>Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak expiratory flow (PEF)</measure>
    <time_frame>1 minute</time_frame>
    <description>Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L/second (seg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean expiratory flow (FEF25-75)</measure>
    <time_frame>1 minute</time_frame>
    <description>Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure L/seg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital capacity (VC)</measure>
    <time_frame>1 minute</time_frame>
    <description>Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tidal volume (VT)</measure>
    <time_frame>1 minute</time_frame>
    <description>Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced vital capacity (FVC)</measure>
    <time_frame>1 minute</time_frame>
    <description>Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional capacity</measure>
    <time_frame>6 minutes</time_frame>
    <description>The 6 minutes walk test provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea</measure>
    <time_frame>1 minute</time_frame>
    <description>Modified Borg scale. It is a numerical scale graduated between 0 and 10, where 0 is the minimum or without dyspnea and 10 is the maximum or extreme dyspnea.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Respiratory Insufficiency</condition>
  <arm_group>
    <arm_group_label>&quot;High intensity group&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention is administrated with an inspiratory muscle trainer (IMT). High intensity group: 15 cycles, 1 minute each one, 40% MIP with IMT. 1 minute to rest between cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;Low intensity group&quot;</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention is administrated with an inspiratory muscle trainer (IMT). Low intensity group: 15 cycles, 1 minute each one, 20% MIP with IMT. 1 minute to rest between cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Inspiratory muscle trainer (IMT)</intervention_name>
    <description>The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O).</description>
    <arm_group_label>&quot;High intensity group&quot;</arm_group_label>
    <arm_group_label>&quot;Low intensity group&quot;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  Older 65 years&#xD;
&#xD;
          -  Barthel &gt; 60&#xD;
&#xD;
          -  Understand the objectives and be able to complete questionaires&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Respiratory pathology during the 4 weeks prior the start of the study&#xD;
&#xD;
          -  Any complication that may impeded the performance of the evaluation tests or breathing&#xD;
             techniques&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ANA MARIA MARTIN-NOGUERAS, DR</last_name>
    <role>Study Chair</role>
    <affiliation>University of Salamanca</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carlos Martin Sanchez</name>
      <address>
        <city>Salamanca</city>
        <zip>37006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>October 29, 2019</last_update_submitted>
  <last_update_submitted_qc>October 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Salamanca</investigator_affiliation>
    <investigator_full_name>CARLOS MARTIN SANCHEZ</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>REHABILITATION</keyword>
  <keyword>RESPIRATION</keyword>
  <keyword>BREATHING EXERCISE</keyword>
  <keyword>FATIGUE</keyword>
  <keyword>PHYSICAL CAPACITY</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</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/NCT03827356
org study id: 27112018
nct id: NCT03827356
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: To evaluate the effectiveness of two protocols of inspiratory muscle training
      (IMT) in older women to improve respiratory strength, spirometric parameters and dyspnea.
      Low-intensity vs high-intensity resistance training programs. Evaluations: Determination of
      the maximum inspiratory pressure (MIP) and the maximum expiratory pressure (MEP); spirometry
      - maximum voluntary ventilation (MVV), peak expiratory flow (PEF), tidal volume (TV);
      functional capacity measured with 6 minute walk test; dyspnea using the Borg scale and
      clinical evaluations. The participants will be evaluated at the beginning and end of the
      intervention period. Intervention: There are two groups of patients, one works with low loads
      (20% MIP) and another with high loads (40% MIP). They train 5 days/week 15 cycles lasting 1
      minute. There is a rest of 1 minute between each cycle.
Participants:

      Institutionalized women will be recruited to participate in an 8-week randomized trial.

      All patients will be asked to carry out the 5-day weekly program, and a recording sheet will
      be provided to each participant so they will can record the time of each daily respiratory
      training session. All participants signed an informed consent form.

      The patients will be assigned to the two groups randomly. The main researcher doesn´t meet
      any of the participants until the initial assessment will be carried out.

      Evaluation:

      The participants are evaluated at the beginning and end of the intervention period.

      The evaluation of MIP and MEP is performed using a pressure transducer, Elka 15, which
      obtains each measurement in millibar and converts it into the reference unit of centimeter of
      water (cm H2O) (1 mbar = 1.01973 cm H2O .), following the rules of the American thoracic
      society/European respiratory society (ATS / ERS). The procedure will be repeated until 3
      values were obtained with a difference of less than 5%, and the highest value will be used
      for the analysis. The MIP of the intervention group will be assessed every 2 weeks to set the
      IMT workload.

      Lung volumes are assessed using a spirometer (model: datospir touch) with a turbine
      transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules will
      be followed [19], and the highest value of three correct measurements will be chosen. Data is
      collected for the following parameters: maximum voluntary ventilation (MVV), forced
      expiratory volume in the first second (FEV1), peak expiratory flow (PEF), mean expiratory
      flow (FEF25-75), vital capacity (VC), tidal volume (TV) and forced vital capacity (FVC).

      Dyspnea will be measured using the modified Borg scale [20]. Functional capacity will be
      measured with 6 minute walk test. All evaluations will be done in the corresponding center,
      during the same time slot and by the same examiner for both groups.

      Intervention:

      "High-intensity group". The device incorporates a unidirectional valve independent of flow to
      guarantee constant resistance and includes a specific pressure setting (in cm H2O).

      The intensity of the device will be 40% of MIP. The protocol includes 15 cycles lasting 1
      minute, twice a day: one in the morning and one in the afternoon. The participants rest for 1
      minute between each cycle. In total, the protocol includes 30 minutes of daily respiratory
      training. The patients will be instructed to inhale with enough force to reach the opening of
      the valve.

      "Low-intensity group".The device incorporates a unidirectional valve independent of flow to
      guarantee constant resistance and includes a specific pressure setting (in cm H2O).

      The intensity of the device will be 20% of MIP. The protocol includes 15 cycles lasting 1
      minute, twice a day: one in the morning and one in the afternoon. The participants rest for 1
      minute between each cycle. In total, the protocol includes 30 minutes of daily respiratory
      training. The patients will be instructed to inhale with enough force to reach the opening of
      the valve.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients are assigned randomly to the 2 working groups, each patient only receives one of the two protocols.
primary purpose: Treatment
masking: Single (Investigator)
masking description: The principal investigator doesn´t know the group of the patients until the study ends
measure: Maximal inspiratory pressure (MIP)
time frame: 2 minutes
description: The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the American Thoracic Society/European Respiratory Society (ATS / ERS). The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis. The MIP of the intervention group was assessed every 2 weeks to set the IMT workload.
measure: Maximal expiratory pressure (MEP)
time frame: 2 minutes
description: The evaluation is performed using a pressure transducer, Elka 15. It is evaluated at the beginning and at the end of the interventional phase.
measure: Maximum voluntary ventilation (MVV)
time frame: 1 minute
description: Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: Liter (L)/Minute (min)
measure: Forced expiratory volume in the first second (FEV1)
time frame: 1 minute
description: Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L
measure: Peak expiratory flow (PEF)
time frame: 1 minute
description: Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L/second (seg)
measure: Mean expiratory flow (FEF25-75)
time frame: 1 minute
description: Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure L/seg
measure: Vital capacity (VC)
time frame: 1 minute
description: Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L
measure: Tidal volume (VT)
time frame: 1 minute
description: Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L
measure: Forced vital capacity (FVC)
time frame: 1 minute
description: Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L
measure: Functional capacity
time frame: 6 minutes
description: The 6 minutes walk test provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
measure: Dyspnea
time frame: 1 minute
description: Modified Borg scale. It is a numerical scale graduated between 0 and 10, where 0 is the minimum or without dyspnea and 10 is the maximum or extreme dyspnea.
arm group label: "High intensity group"
arm group type: Experimental
description: Intervention is administrated with an inspiratory muscle trainer (IMT). High intensity group: 15 cycles, 1 minute each one, 40% MIP with IMT. 1 minute to rest between cycles.
arm group label: "Low intensity group"
arm group type: Active Comparator
description: Intervention is administrated with an inspiratory muscle trainer (IMT). Low intensity group: 15 cycles, 1 minute each one, 20% MIP with IMT. 1 minute to rest between cycles.
intervention type: Device
intervention name: Inspiratory muscle trainer (IMT)
description: The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O).
arm group label: "High intensity group"
arm group label: "Low intensity group"
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: ANA MARIA MARTIN-NOGUERAS, DR
role: Study Chair
affiliation: University of Salamanca
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Salamanca
investigator full name: CARLOS MARTIN SANCHEZ
investigator title: Principal Investigator
mesh term: Respiratory Insufficiency
sharing ipd: No