<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/NCT03297918</url>
  </required_header>
  <id_info>
    <org_study_id>HeartChoir</org_study_id>
    <nct_id>NCT03297918</nct_id>
  </id_info>
  <brief_title>Impact of a Structural Phonation Training on Respiratory Muscle Function in Patients With Structural Heart Disease</brief_title>
  <official_title>Impact of a Structural Phonation Training on Respiratory Muscle Function in Patients With Structural Heart Disease - HeartChoir</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      Most patients with complex congenital heart disease and cardiomyopathy from acquired heart&#xD;
      disease have reduced exercise capacity. Exercise capacity is associated with respiratory&#xD;
      muscle strength and function. If structured respiratory muscle training positively influences&#xD;
      respiratory muscle function in patients with structural heart disease is not well known. The&#xD;
      aim of this study is to investigate whether regular singing lessons and breathing exercises&#xD;
      improve respiratory muscle strength in patients with congenital or acquired structural heart&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most patients with complex congenital heart disease and cardiomyopathy from acquired heart&#xD;
      disease have reduced exercise capacity (VO2 max). Furthermore, exercise capacity is&#xD;
      associated with respiratory muscle strength and function (maximal inspiratory (MIP) and&#xD;
      maximal respiratory (MEP) pressures. If structured respiratory muscle training positively&#xD;
      influences respiratory muscle function in patients with complex congenital heart disease or&#xD;
      cardiomyopathy from acquired heart disease is not well known.&#xD;
&#xD;
      Aim: The aim of this study is to investigate the influence of a structured phonation and&#xD;
      respiratory training with regular singing lessons on respiratory muscle strength and function&#xD;
      (MIP and MEP), exercise capacity (VO2 max), NT-proBNP and quality of life.&#xD;
&#xD;
      This is an interventional, single-centre, randomized study. Patients will be recruited from&#xD;
      the heart failure and congenital heart disease clinic of the University hospital Basel.&#xD;
      Patients will be asked to participate in a structured phonation and respiratory muscle&#xD;
      training for 12 weeks. The structured phonation and respiratory muscle training includes&#xD;
      weekly singing lessons in a choir, held by a professional instructor, with additional&#xD;
      instructions for daily respiratory muscle strength training at home. Respiratory muscle&#xD;
      function (MIP and MEP), exercise capacity (VO2max) and quality of life will be measured at&#xD;
      the beginning of the intervention and after 12 weeks of interventional training. In parallel,&#xD;
      respiratory muscle function, exercise capacity, NT-proBNP and quality of life will be&#xD;
      measured in a gender and age matched group of patients without performing the intervention&#xD;
      and in a healthy control group who co-participate the choir lessons and the respiratory&#xD;
      muscle training. Primary endpoint is the change of maximal inspiratory pressures (MIP)&#xD;
      between patients with and without a structured phonation and respiratory muscle training.&#xD;
      Secondary endpoints are changes of MEP, VO2max, NT-proBNP and quality of life between&#xD;
      patients with and without the intervention; changes of all measured variables between&#xD;
      patients and the healthy control group, and changes of all measured variables before and&#xD;
      after the intervention in patients. Inclusion criteria: Patients &gt;18 years with known&#xD;
      cardiomyopathy from acquired heart disease (ischemic or dilated) or complex forms of&#xD;
      congenital heart disease. Exclusion criteria: Acute coronary syndrome ≤6 months or heart&#xD;
      failure hospitalization ≤12 months.&#xD;
&#xD;
      Structural singing lesions and respiratory muscle function training may improve respiratory&#xD;
      muscle strength, exercise capacity and quality of life in patients with heart failure or&#xD;
      complex congenital heart disease. The intervention comes at low costs, can be applied by most&#xD;
      of the patients and is feasible even for disabled patients who are not able to participate in&#xD;
      regular exercise training. Furthermore, singing may improve respiratory muscle strength and&#xD;
      exercise capacity even in the healthy population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2018</start_date>
  <completion_date type="Actual">October 10, 2018</completion_date>
  <primary_completion_date type="Actual">August 18, 2018</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>Interventional, single-center, randomised clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>randomised</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal inspiratory pressure in kilopascal</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change of maximal inspiratory pressure after the intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of MEP</measure>
    <time_frame>12 wees</time_frame>
    <description>Change of maximal expiratory pressure after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of MVO2</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change of maximal VO2 after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of QoL</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change of Quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NT-proBNP</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change of Level of NT-proBNP after the intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Heart Failure</condition>
  <condition>Congenital Heart Disease</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be asked to participate in a structured singing and respiratory training for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Respiratory muscle training</intervention_name>
    <description>The intervention is two-parted and includes weekly singing lessons in a choir, held by a professional instructor, with additional instructions for daily breathing exercise at home.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent as documented by signature (Appendix Informed Consent Form)&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
          -  known cardiomyopathy from acquired heart disease (ischemic or dilated) or patients&#xD;
             with complex CHD (cyanotic congenital heart disease, Fontan palliation, subaortic&#xD;
             right ventricle or repaired tetralogy of Fallot)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute coronary syndrome, cardiac surgery or heart failure hospitalization within the&#xD;
             previous 6 months&#xD;
&#xD;
          -  chronic metabolic, orthopedic, or infectious disease; treatment with steroids,&#xD;
             hormones, or cancer chemotherapy&#xD;
&#xD;
          -  severe exercise-induced asthma&#xD;
&#xD;
          -  professional singer or professionally performing a wind instrument&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Tobler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</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/NCT03297918
org study id: HeartChoir
nct id: NCT03297918
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Most patients with complex congenital heart disease and cardiomyopathy from acquired heart
      disease have reduced exercise capacity. Exercise capacity is associated with respiratory
      muscle strength and function. If structured respiratory muscle training positively influences
      respiratory muscle function in patients with structural heart disease is not well known. The
      aim of this study is to investigate whether regular singing lessons and breathing exercises
      improve respiratory muscle strength in patients with congenital or acquired structural heart
      disease.
Most patients with complex congenital heart disease and cardiomyopathy from acquired heart
      disease have reduced exercise capacity (VO2 max). Furthermore, exercise capacity is
      associated with respiratory muscle strength and function (maximal inspiratory (MIP) and
      maximal respiratory (MEP) pressures. If structured respiratory muscle training positively
      influences respiratory muscle function in patients with complex congenital heart disease or
      cardiomyopathy from acquired heart disease is not well known.

      Aim: The aim of this study is to investigate the influence of a structured phonation and
      respiratory training with regular singing lessons on respiratory muscle strength and function
      (MIP and MEP), exercise capacity (VO2 max), NT-proBNP and quality of life.

      This is an interventional, single-centre, randomized study. Patients will be recruited from
      the heart failure and congenital heart disease clinic of the University hospital Basel.
      Patients will be asked to participate in a structured phonation and respiratory muscle
      training for 12 weeks. The structured phonation and respiratory muscle training includes
      weekly singing lessons in a choir, held by a professional instructor, with additional
      instructions for daily respiratory muscle strength training at home. Respiratory muscle
      function (MIP and MEP), exercise capacity (VO2max) and quality of life will be measured at
      the beginning of the intervention and after 12 weeks of interventional training. In parallel,
      respiratory muscle function, exercise capacity, NT-proBNP and quality of life will be
      measured in a gender and age matched group of patients without performing the intervention
      and in a healthy control group who co-participate the choir lessons and the respiratory
      muscle training. Primary endpoint is the change of maximal inspiratory pressures (MIP)
      between patients with and without a structured phonation and respiratory muscle training.
      Secondary endpoints are changes of MEP, VO2max, NT-proBNP and quality of life between
      patients with and without the intervention; changes of all measured variables between
      patients and the healthy control group, and changes of all measured variables before and
      after the intervention in patients. Inclusion criteria: Patients >18 years with known
      cardiomyopathy from acquired heart disease (ischemic or dilated) or complex forms of
      congenital heart disease. Exclusion criteria: Acute coronary syndrome ≤6 months or heart
      failure hospitalization ≤12 months.

      Structural singing lesions and respiratory muscle function training may improve respiratory
      muscle strength, exercise capacity and quality of life in patients with heart failure or
      complex congenital heart disease. The intervention comes at low costs, can be applied by most
      of the patients and is feasible even for disabled patients who are not able to participate in
      regular exercise training. Furthermore, singing may improve respiratory muscle strength and
      exercise capacity even in the healthy population.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Interventional, single-center, randomised clinical trial
primary purpose: Treatment
masking: Single (Participant)
masking description: randomised
measure: Maximal inspiratory pressure in kilopascal
time frame: 12 weeks
description: Change of maximal inspiratory pressure after the intervention
measure: Change of MEP
time frame: 12 wees
description: Change of maximal expiratory pressure after the intervention
measure: Change of MVO2
time frame: 12 weeks
description: Change of maximal VO2 after the intervention
measure: Change of QoL
time frame: 12 weeks
description: Change of Quality of life
measure: NT-proBNP
time frame: 12 weeks
description: Change of Level of NT-proBNP after the intervention
arm group label: Intervention group
arm group type: Active Comparator
description: Patients will be asked to participate in a structured singing and respiratory training for 12 weeks.
arm group label: Control group
arm group type: No Intervention
description: no intervention
intervention type: Behavioral
intervention name: Respiratory muscle training
description: The intervention is two-parted and includes weekly singing lessons in a choir, held by a professional instructor, with additional instructions for daily breathing exercise at home.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Tobler, MD
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
sharing ipd: No