<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/NCT03838003</url>
  </required_header>
  <id_info>
    <org_study_id>ERIC</org_study_id>
    <nct_id>NCT03838003</nct_id>
  </id_info>
  <brief_title>Exercise in Patients Admitted With Recently Decompensated Heart Failure</brief_title>
  <acronym>ERIC</acronym>
  <official_title>Rehabilitation Nursing on Patients Admitted by Recently Decompensated Heart Failure (ERIC Program) - Impact of Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Porto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centro Hospitalar do Porto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Politécnico de Bragança</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade do Porto</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>
      An aerobic physical exercise protocol will be applied to patients admitted in ward due to&#xD;
      decompensated heart failure, in order to validate the efficacy and safety of physical&#xD;
      exercise in this phase of clinical stabilization, through the said training protocol - ERIC&#xD;
      program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the objective of validating the efficacy and safety of physical exercise as a&#xD;
      therapeutic resource in patients admitted for decompensated heart failure; will be applied,&#xD;
      by rehabilitation nurses, a protocol of physical exercise, with increasing levels of&#xD;
      intensity. Patients who meet the inclusion criteria will be randomized through an online&#xD;
      program (randomizer.org) and the ERIC protocol will be applied to the test group. The control&#xD;
      group will be implemented the usual care of rehabilitation nursing. The ERIC protocol&#xD;
      comprises 5 levels of intensity, as following shown: Stage 1 - respiratory and calisthenic&#xD;
      exercises (5-10 minutes) Stage 2 - pedal for 5-10 minutes Stage 3 - aerobic training: walking&#xD;
      on the corridor for 5-10 minutes Stage 4 - aerobic training: walking on the corridor for&#xD;
      10-15 minutes Stage 5 - aerobic training: walking on the corridor for 15 minutes + climbing&#xD;
      stairs for 5 minutes All patients will be monitored and followed up by a rehabilitation nurse&#xD;
      while they are doing the exercise. The investigator decides, depending on the patient's&#xD;
      performance and clinical conditions, the form of progression in the program, but it is&#xD;
      mandatory to follow the previously defined levels of intensity.&#xD;
&#xD;
      Patients in the test group may start the program only on stage I or II according to clinical&#xD;
      criteria. At admission of the patients (test group and control group) clinical and&#xD;
      sociodemographic parameters are evaluated, as well as data related to Barthel's indices and&#xD;
      London Chest of activities of daily living (LCADL). At the discharge date, the Barthel index&#xD;
      and the LCADL scale will also be evaluated, as well as the 6-minute walking test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6 minute walking test</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Number of meters walked in the 6 minute walking test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Barthel Index score</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Barthel evaluates dependence on self-care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>London Chest Activity of Daily Living (LCADL) scale score</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>LIDL accesses how dyspnea affects self-care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of dysrhythmias during exercise in the training group</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>To quantify the number of dysrhythmias during exercise in the training group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of falls during exercise in the training group</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>To quantify the number of falls during exercise in the training group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of emergency situations during exercise in the training group</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>To quantify the number of emergency situations during exercise in the training group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of chest pain situations during exercise in the training group</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>To quantify the chest pain situations during exercise in the training group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Decompensated Heart Failure</condition>
  <condition>Functional Cardiac Disorder</condition>
  <arm_group>
    <arm_group_label>Experimental: Training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Intervention: Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients admitted due to decompensated heart failure who will perform the standard rehabilitation nursing care for this type of patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ERIC protocol</intervention_name>
    <description>ERIC protocol is an aerobic exercise protocol with 5 levels of intensity</description>
    <arm_group_label>Experimental: Training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission diagnosis of Decompensated heart failure&#xD;
&#xD;
          -  More than 18 years old&#xD;
&#xD;
          -  Capacity to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Osteoarticular pathology that impedes the performance of the exercise&#xD;
&#xD;
          -  Existence of inotropic infusions&#xD;
&#xD;
          -  Dysrhythmia or precordial pain in the last 24 hours&#xD;
&#xD;
          -  Acute pulmonary edema in the last 12 hours&#xD;
&#xD;
          -  Systolic blood pressure greater than 180millimetre of mercury (mmHg) or less than&#xD;
             80mmHg (except in cases where this is the baseline value for the patient)&#xD;
&#xD;
          -  Need for oxygen at a rate greater than 3 /min&#xD;
&#xD;
          -  Glycemic decompensation in the last 12 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centro Hospitalar do Porto</name>
      <address>
        <city>Oporto</city>
        <zip>4000</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>September 9, 2021</last_update_submitted>
  <last_update_submitted_qc>September 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Rehabilitation Nursing</keyword>
  <keyword>Functional capacity</keyword>
  <keyword>Heart failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Heart Diseases</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/NCT03838003
org study id: ERIC
nct id: NCT03838003
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An aerobic physical exercise protocol will be applied to patients admitted in ward due to
      decompensated heart failure, in order to validate the efficacy and safety of physical
      exercise in this phase of clinical stabilization, through the said training protocol - ERIC
      program.
With the objective of validating the efficacy and safety of physical exercise as a
      therapeutic resource in patients admitted for decompensated heart failure; will be applied,
      by rehabilitation nurses, a protocol of physical exercise, with increasing levels of
      intensity. Patients who meet the inclusion criteria will be randomized through an online
      program (randomizer.org) and the ERIC protocol will be applied to the test group. The control
      group will be implemented the usual care of rehabilitation nursing. The ERIC protocol
      comprises 5 levels of intensity, as following shown: Stage 1 - respiratory and calisthenic
      exercises (5-10 minutes) Stage 2 - pedal for 5-10 minutes Stage 3 - aerobic training: walking
      on the corridor for 5-10 minutes Stage 4 - aerobic training: walking on the corridor for
      10-15 minutes Stage 5 - aerobic training: walking on the corridor for 15 minutes + climbing
      stairs for 5 minutes All patients will be monitored and followed up by a rehabilitation nurse
      while they are doing the exercise. The investigator decides, depending on the patient's
      performance and clinical conditions, the form of progression in the program, but it is
      mandatory to follow the previously defined levels of intensity.

      Patients in the test group may start the program only on stage I or II according to clinical
      criteria. At admission of the patients (test group and control group) clinical and
      sociodemographic parameters are evaluated, as well as data related to Barthel's indices and
      London Chest of activities of daily living (LCADL). At the discharge date, the Barthel index
      and the LCADL scale will also be evaluated, as well as the 6-minute walking test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: 6 minute walking test
time frame: through study completion, an average of 1 year
description: Number of meters walked in the 6 minute walking test
measure: Barthel Index score
time frame: through study completion, an average of 1 year
description: Barthel evaluates dependence on self-care
measure: London Chest Activity of Daily Living (LCADL) scale score
time frame: through study completion, an average of 1 year
description: LIDL accesses how dyspnea affects self-care
measure: Number of dysrhythmias during exercise in the training group
time frame: through study completion, an average of 1 year
description: To quantify the number of dysrhythmias during exercise in the training group
measure: Number of falls during exercise in the training group
time frame: through study completion, an average of 1 year
description: To quantify the number of falls during exercise in the training group
measure: Number of emergency situations during exercise in the training group
time frame: through study completion, an average of 1 year
description: To quantify the number of emergency situations during exercise in the training group
measure: Number of chest pain situations during exercise in the training group
time frame: through study completion, an average of 1 year
description: To quantify the chest pain situations during exercise in the training group
arm group label: Experimental: Training group
arm group type: Experimental
description: Patients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol
arm group label: No Intervention: Control group
arm group type: No Intervention
description: Patients admitted due to decompensated heart failure who will perform the standard rehabilitation nursing care for this type of patients
intervention type: Procedure
intervention name: ERIC protocol
description: ERIC protocol is an aerobic exercise protocol with 5 levels of intensity
arm group label: Experimental: Training group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Portugal
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Heart Diseases
sharing ipd: No