<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/NCT03247361</url>
  </required_header>
  <id_info>
    <org_study_id>FUBahia HIIT IMT</org_study_id>
    <nct_id>NCT03247361</nct_id>
  </id_info>
  <brief_title>High-intensity vs. Low-intensity Inspiratory Muscle Training in Patients With Heart Failure</brief_title>
  <official_title>The Addition of High-intensity vs. Low-intensity Inspiratory Muscle Training to Combined Aerobic and Resistance Exercise in Patients With Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Bahia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Bahia</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>
      It is well-known that muscle weakness and deconditioning play an important role in low&#xD;
      exercise capacity of patients with HF. Interestingly, not only peripheral muscles are&#xD;
      impaired, but also respiratory muscles. Studies have shown that patients with HF may have, in&#xD;
      addition to decreasing maximal inspiratory muscle strength and endurance, metabolic and&#xD;
      structural impairments in diaphragm fibers. Moreover, exercise capacity and weakness of&#xD;
      inspiratory muscles have been associated with low quality of life and poor prognosis, which&#xD;
      make the addition of inspiratory muscle training (IMT) reasonable in cardiovascular&#xD;
      rehabilitation.The specifications of the loads to be imposed during IMT is the main factor&#xD;
      determining the outcome. Studies of IMT have highlighted the need for a fixed inspiratory&#xD;
      workload during exercise. Thus, purpose of this report was to perform a randomized clinical&#xD;
      trial of the effects of addition of high-intensity vs. low-intensity IMT to combined aerobic&#xD;
      and resistance Exercise in patients with heart failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Aerobic Capacity</measure>
    <time_frame>10 weeks</time_frame>
    <description>Six-minute walk test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health-Related Quality of Life: MLHFQ</measure>
    <time_frame>10 weeks</time_frame>
    <description>Health-Related Quality of Life will be measured by a questionnaire (Minnesota Living with Heart Failure questionnaire - MLHFQ)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory muscle strength</measure>
    <time_frame>10 weeks</time_frame>
    <description>Maximal respiratory pressures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>10 weeks</time_frame>
    <description>The World Health Organization Disability Assessment Schedule (WHODAS 2.0)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>High-intensity IMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-intensity IMT + Aerobic/resistance exercise&#xD;
IMT: Training loads will be adjusted weekly to the maximal inspiratory pressure (MIP). In the first 2 weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 30 sec, with 30-sec of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 10 min and 30 sec. From the third week the protocol will be of 2 min warm-up with intensity 30% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 60 sec, with 60-second of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 17 min.&#xD;
Exercise: see group Combined aerobic/resistance exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-intensity IMT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low-intensity IMT + Aerobic/resistance exercise&#xD;
IMT:Training loads will be also adjusted weekly to the maximal inspiratory pressure (MIP). In the first two weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will be held with 3 sets of 15 repetitions, with 40% of MIP, finishing the training with 20% of MIP for 2 minutes. From the third week the protocol will be of 2 minutes warm-up with intensity 30% of MIP. The training will be held with 3 sets of 15 repetitions, with 60% of MIP, finishing the training with 30% of MIP for 2 minutes.&#xD;
Exercise: see group Combined aerobic/resistance exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aerobic/resistance exercise</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham IMT + Aerobic/resistance exercise&#xD;
Aerobic session will consist of a 4-min of warm-up, 20 minutes of exercise, and 4 min of cool-down. Intensity will set by the formula: Training HR = (maximum HR - resting HR) × intensity % + resting HR. Patients will exercise using 30 seconds, high-intensity work phases 0.7% followed by 1-minute recovery bouts 0.5%. Resistance exercise will consist of dynamic lower and upper limb exercise. Upper limb exercises will include 3 sets of exercises for each muscle group performed with 10 repetitions each. Lower limb exercises will include 3 sets of exercises for each muscle group performed with 12 repetitions each. Resistance exercises will be performed at 12-MR.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-intensity IMT + Aerobic/resistance exercise</intervention_name>
    <description>High-intensity IMT</description>
    <arm_group_label>High-intensity IMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-intensity IMT + Aerobic/resistance exercise</intervention_name>
    <description>Low-intensity IMT</description>
    <arm_group_label>Low-intensity IMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham IMT + Aerobic/resistance exercise</intervention_name>
    <description>Aerobic and resistance exercise</description>
    <arm_group_label>Aerobic/resistance exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The target population consists of adults patients aged ≥ 18 years with heart failure&#xD;
             and New York Heart Association (NYHA) class I-III.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable angina;&#xD;
&#xD;
          -  coronary revascularization;&#xD;
&#xD;
          -  Decompensated heart failure functional class IV (NYHA);&#xD;
&#xD;
          -  Recent transplant or hospitalization (6 months &lt;);&#xD;
&#xD;
          -  Chronic Obstructive Pulmonary Disease;&#xD;
&#xD;
          -  Neuromuscular, Orthopedic, Neurologic and Neoplastic Diseases;&#xD;
&#xD;
          -  Recent myocardial infarction or cardiac surgery (less than 6 months);&#xD;
&#xD;
          -  Atrial Fibrillation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mansueto Gomes-Neto, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Bahia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mansueto Gomes-Neto, PhD</last_name>
    <phone>55-71-999188277</phone>
    <email>mansueto.neto@ufba.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mansueto Gomes Neto</name>
      <address>
        <city>Salvador</city>
        <state>BA</state>
        <zip>40100-110</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mansueto G Neto, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>November 5, 2018</last_update_submitted>
  <last_update_submitted_qc>November 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Bahia</investigator_affiliation>
    <investigator_full_name>Mansueto Gomes Neto</investigator_full_name>
    <investigator_title>Principal researcher</investigator_title>
  </responsible_party>
  <keyword>Heart Failure; Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT03247361
org study id: FUBahia HIIT IMT
nct id: NCT03247361
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is well-known that muscle weakness and deconditioning play an important role in low
      exercise capacity of patients with HF. Interestingly, not only peripheral muscles are
      impaired, but also respiratory muscles. Studies have shown that patients with HF may have, in
      addition to decreasing maximal inspiratory muscle strength and endurance, metabolic and
      structural impairments in diaphragm fibers. Moreover, exercise capacity and weakness of
      inspiratory muscles have been associated with low quality of life and poor prognosis, which
      make the addition of inspiratory muscle training (IMT) reasonable in cardiovascular
      rehabilitation.The specifications of the loads to be imposed during IMT is the main factor
      determining the outcome. Studies of IMT have highlighted the need for a fixed inspiratory
      workload during exercise. Thus, purpose of this report was to perform a randomized clinical
      trial of the effects of addition of high-intensity vs. low-intensity IMT to combined aerobic
      and resistance Exercise in patients with heart failure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Aerobic Capacity
time frame: 10 weeks
description: Six-minute walk test
measure: Health-Related Quality of Life: MLHFQ
time frame: 10 weeks
description: Health-Related Quality of Life will be measured by a questionnaire (Minnesota Living with Heart Failure questionnaire - MLHFQ)
measure: Respiratory muscle strength
time frame: 10 weeks
description: Maximal respiratory pressures
measure: Disability
time frame: 10 weeks
description: The World Health Organization Disability Assessment Schedule (WHODAS 2.0)
arm group label: High-intensity IMT
arm group type: Experimental
description: High-intensity IMT + Aerobic/resistance exercise
IMT: Training loads will be adjusted weekly to the maximal inspiratory pressure (MIP). In the first 2 weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 30 sec, with 30-sec of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 10 min and 30 sec. From the third week the protocol will be of 2 min warm-up with intensity 30% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 60 sec, with 60-second of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 17 min.
Exercise: see group Combined aerobic/resistance exercise
arm group label: Low-intensity IMT
arm group type: Active Comparator
description: Low-intensity IMT + Aerobic/resistance exercise
IMT:Training loads will be also adjusted weekly to the maximal inspiratory pressure (MIP). In the first two weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will be held with 3 sets of 15 repetitions, with 40% of MIP, finishing the training with 20% of MIP for 2 minutes. From the third week the protocol will be of 2 minutes warm-up with intensity 30% of MIP. The training will be held with 3 sets of 15 repetitions, with 60% of MIP, finishing the training with 30% of MIP for 2 minutes.
Exercise: see group Combined aerobic/resistance exercise
arm group label: Aerobic/resistance exercise
arm group type: Sham Comparator
description: Sham IMT + Aerobic/resistance exercise
Aerobic session will consist of a 4-min of warm-up, 20 minutes of exercise, and 4 min of cool-down. Intensity will set by the formula: Training HR = (maximum HR - resting HR) × intensity % + resting HR. Patients will exercise using 30 seconds, high-intensity work phases 0.7% followed by 1-minute recovery bouts 0.5%. Resistance exercise will consist of dynamic lower and upper limb exercise. Upper limb exercises will include 3 sets of exercises for each muscle group performed with 10 repetitions each. Lower limb exercises will include 3 sets of exercises for each muscle group performed with 12 repetitions each. Resistance exercises will be performed at 12-MR.
intervention type: Other
intervention name: High-intensity IMT + Aerobic/resistance exercise
description: High-intensity IMT
arm group label: High-intensity IMT
intervention type: Other
intervention name: Low-intensity IMT + Aerobic/resistance exercise
description: Low-intensity IMT
arm group label: Low-intensity IMT
intervention type: Other
intervention name: Sham IMT + Aerobic/resistance exercise
description: Aerobic and resistance exercise
arm group label: Aerobic/resistance exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mansueto Gomes-Neto, PhD
role: Principal Investigator
affiliation: Federal University of Bahia
last name: Mansueto Gomes-Neto, PhD
phone: 55-71-999188277
email: mansueto.neto@ufba.br
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Bahia
investigator full name: Mansueto Gomes Neto
investigator title: Principal researcher
mesh term: Heart Failure