<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/NCT02263482</url>
  </required_header>
  <id_info>
    <org_study_id>CEP 232/12</org_study_id>
    <secondary_id>FAPESP 2013/13598-1</secondary_id>
    <nct_id>NCT02263482</nct_id>
  </id_info>
  <brief_title>Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure</brief_title>
  <official_title>Inspiratory Muscle and Peripheral Muscle Combined Training Effects on the Respiratory and Functional Capacity and Quality of Life in Chronic Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Naomi Kondo Nakagawa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Dante Pazzanese de Cardiologia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heart failure is a clinical syndrome that is the common end of several cardiac diseases with&#xD;
      symptoms such as muscle fatigue, dyspnea and reduction of quality of life. To improve&#xD;
      respiratory and general functional capacity of these patients, there are strategies that can&#xD;
      be used such as inspiratory muscle training and peripheral muscle training (dynamic&#xD;
      resistance training).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After agreement with the written informed consent, 35 subjects with severe heart failure were&#xD;
      included in this study. They were randomized in three groups: controls, low-intensity and&#xD;
      moderate-intensity group. All volunteers were assessed at Baseline and 8-weeks intervention.&#xD;
      Cardiac events were registered following two years from baseline. The present study aimed to&#xD;
      assess the effects of a combined program of inspiratory and peripheral muscle training on&#xD;
      respiratory and general functional capacity and quality of life in patients with chronic&#xD;
      heart failure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in respiratory muscle strength (in centimeters of water)</measure>
    <time_frame>Before and after 8-weeks</time_frame>
    <description>Inspiratory and expiratory muscle strength was assessed by using a pressure transducer (MVD-300 Microhard System, GlobalMed, Porto Alegre, Brazil).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>walking distance</measure>
    <time_frame>Before and after 8-weeks</time_frame>
    <description>To assess functional capacity using walking distance (6-min walk test accordingly to ATS and ERS guidelines)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in pulmonary function</measure>
    <time_frame>Before and after 8-weeks</time_frame>
    <description>Pulmonary function will be assessed by spirometry.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in functional capacity</measure>
    <time_frame>Before and after 8-weeks</time_frame>
    <description>1RM</description>
  </other_outcome>
  <other_outcome>
    <measure>Inflammation in the upper airway by cytokines in blood</measure>
    <time_frame>Before and after 8-weeks</time_frame>
    <description>MMP2, myoglobin, p-selectin, MPO, NGAL, sVCAM, IL-2, IL-3, IL-4, IL-8,MIP1-alpha, 17, VEGF by Multiplex analysis. Inflammatory cells in nasal lavage will be also investigated.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in heart rate variability (HRV)</measure>
    <time_frame>Before and after 8-weeks</time_frame>
    <description>HRV is obtained from the spectral analysis of R-R intervals obtained from a heart rate monitor (Polar, S810, Kempele, Finland)</description>
  </other_outcome>
  <other_outcome>
    <measure>Prevalence of cardiac events and arrhythmia</measure>
    <time_frame>Before and after 8-weeks</time_frame>
    <description>by a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in international Physical Activity Questionnaire (IPAQ)</measure>
    <time_frame>Before and after 8-weeks</time_frame>
    <description>Patients will be classified as sedentary, irregularly active, active or verry active according to Matsudo's classification (2001).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in quality of life using Minnesota Questionnaire</measure>
    <time_frame>Before and after 8-weeks</time_frame>
    <description>by Short Form-36 and by Minnesota Living with Heart Failure Questionnaire&#xD;
- Minnesota living with heart failure questionaire: contains 21 questions of physical, social, economic and emotional aspects. Each question ranges from zero to five points, with a total score of 105 points which is the maximum severity degree related to personal perception of quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in brain natriuretic peptide (BNP) analysis</measure>
    <time_frame>Before and after 8-weeks</time_frame>
    <description>A blood sample of 5 ml will be collected in a tube and BNP measured</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Chronic Heart Failure</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients awaiting for evaluation to cardiac rehabilitation or transplantation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>moderate-intensity group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be submitted to a 8-weeks training program, with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with upper and lower exercises (50% of the 1-maximum repetition test).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low-intensity group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 Kg each).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control</intervention_name>
    <description>No intervention during the 8-weeks period of the study because of awaiting evaluation for cardiac rehabilitation or transplantation</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>moderate-intensity group</intervention_name>
    <description>Patients will be submitted to a 8-weeks training program with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (50% 1 RM, increased every 2-weeks).</description>
    <arm_group_label>moderate-intensity group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>low-intensity group</intervention_name>
    <description>Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 kg each)</description>
    <arm_group_label>low-intensity group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic heart failure (functional class from NYHA II and III),&#xD;
&#xD;
          -  left ventricle ejection fraction bellow or equal 40%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uncontrolled arrhythmia&#xD;
&#xD;
          -  pulmonary edema or pulmonary congestion in the last 30 days&#xD;
&#xD;
          -  peripheral oxygen saturation bellow 92% in resting condition&#xD;
&#xD;
          -  respiratory infection in the previous 30 days to the enrollment into the study&#xD;
&#xD;
          -  cognitive, neurological or orthopedic limitations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naomi K Nakagawa, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Dante Pazzanese de Cardiologia</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04012-909</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>December 4, 2015</last_update_submitted>
  <last_update_submitted_qc>December 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Naomi Kondo Nakagawa</investigator_full_name>
    <investigator_title>Associate Professor of Medical School of Sao Paulo University</investigator_title>
  </responsible_party>
  <keyword>muscle training</keyword>
  <keyword>walking test</keyword>
  <keyword>chronic heart failure</keyword>
  <keyword>functional capacity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>June 8, 2016</submitted>
    <returned>July 20, 2016</returned>
    <submitted>October 4, 2016</submitted>
    <returned>November 22, 2016</returned>
    <submitted>April 17, 2018</submitted>
    <returned>November 9, 2018</returned>
  </pending_results>
  <!-- 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/NCT02263482
org study id: CEP 232/12
secondary id: FAPESP 2013/13598-1
nct id: NCT02263482
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Heart failure is a clinical syndrome that is the common end of several cardiac diseases with
      symptoms such as muscle fatigue, dyspnea and reduction of quality of life. To improve
      respiratory and general functional capacity of these patients, there are strategies that can
      be used such as inspiratory muscle training and peripheral muscle training (dynamic
      resistance training).
After agreement with the written informed consent, 35 subjects with severe heart failure were
      included in this study. They were randomized in three groups: controls, low-intensity and
      moderate-intensity group. All volunteers were assessed at Baseline and 8-weeks intervention.
      Cardiac events were registered following two years from baseline. The present study aimed to
      assess the effects of a combined program of inspiratory and peripheral muscle training on
      respiratory and general functional capacity and quality of life in patients with chronic
      heart failure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in respiratory muscle strength (in centimeters of water)
time frame: Before and after 8-weeks
description: Inspiratory and expiratory muscle strength was assessed by using a pressure transducer (MVD-300 Microhard System, GlobalMed, Porto Alegre, Brazil).
measure: walking distance
time frame: Before and after 8-weeks
description: To assess functional capacity using walking distance (6-min walk test accordingly to ATS and ERS guidelines)
measure: Change in pulmonary function
time frame: Before and after 8-weeks
description: Pulmonary function will be assessed by spirometry.
measure: Change in functional capacity
time frame: Before and after 8-weeks
description: 1RM
measure: Inflammation in the upper airway by cytokines in blood
time frame: Before and after 8-weeks
description: MMP2, myoglobin, p-selectin, MPO, NGAL, sVCAM, IL-2, IL-3, IL-4, IL-8,MIP1-alpha, 17, VEGF by Multiplex analysis. Inflammatory cells in nasal lavage will be also investigated.
measure: Change in heart rate variability (HRV)
time frame: Before and after 8-weeks
description: HRV is obtained from the spectral analysis of R-R intervals obtained from a heart rate monitor (Polar, S810, Kempele, Finland)
measure: Prevalence of cardiac events and arrhythmia
time frame: Before and after 8-weeks
description: by a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs
measure: Change in international Physical Activity Questionnaire (IPAQ)
time frame: Before and after 8-weeks
description: Patients will be classified as sedentary, irregularly active, active or verry active according to Matsudo's classification (2001).
measure: Change in quality of life using Minnesota Questionnaire
time frame: Before and after 8-weeks
description: by Short Form-36 and by Minnesota Living with Heart Failure Questionnaire
- Minnesota living with heart failure questionaire: contains 21 questions of physical, social, economic and emotional aspects. Each question ranges from zero to five points, with a total score of 105 points which is the maximum severity degree related to personal perception of quality of life.
measure: Change in brain natriuretic peptide (BNP) analysis
time frame: Before and after 8-weeks
description: A blood sample of 5 ml will be collected in a tube and BNP measured
arm group label: Control group
arm group type: Other
description: patients awaiting for evaluation to cardiac rehabilitation or transplantation
arm group label: moderate-intensity group
arm group type: Experimental
description: Patients will be submitted to a 8-weeks training program, with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with upper and lower exercises (50% of the 1-maximum repetition test).
arm group label: low-intensity group
arm group type: Active Comparator
description: Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 Kg each).
intervention type: Other
intervention name: control
description: No intervention during the 8-weeks period of the study because of awaiting evaluation for cardiac rehabilitation or transplantation
arm group label: Control group
intervention type: Other
intervention name: moderate-intensity group
description: Patients will be submitted to a 8-weeks training program with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (50% 1 RM, increased every 2-weeks).
arm group label: moderate-intensity group
intervention type: Other
intervention name: low-intensity group
description: Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 kg each)
arm group label: low-intensity group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Naomi K Nakagawa, PhD
role: Principal Investigator
affiliation: USP
facility: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Naomi Kondo Nakagawa
investigator title: Associate Professor of Medical School of Sao Paulo University
mesh term: Heart Failure
submitted: June 8, 2016
returned: July 20, 2016
submitted: October 4, 2016
returned: November 22, 2016
submitted: April 17, 2018
returned: November 9, 2018