<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/NCT04476576</url>
  </required_header>
  <id_info>
    <org_study_id>exercise and chemotherapy</org_study_id>
    <nct_id>NCT04476576</nct_id>
  </id_info>
  <brief_title>Aerobic Exercise is Cardio-protective in Hemato-oncological Disease and New-onset Chemotherapy</brief_title>
  <acronym>AEROHEMONCO</acronym>
  <official_title>Aerobic Physical Exercise is Cardio-protective in Subjects With Hemato-oncological Disease and New-onset Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lucía Florio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de la Republica</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>
      Oncological diseases are the main cause of death in developed countries and also in Uruguay.&#xD;
      Advances in therapeutics have made possible to aspire to cure and in other cases long-term&#xD;
      remission with a significant increase in survival and the transformation of cancer into a&#xD;
      chronic disease. Chemotherapy treatments have some side effects and cardiotoxicity is well&#xD;
      known within them. Heart failure (HF) is a progressive pathology, with high mortality and&#xD;
      high resource requirements of the health system with a prognosis that may be worse than some&#xD;
      types of cancers. The treatment of established systolic dysfunction and symptomatic HF is&#xD;
      mainly based on the indication of inhibitors of the angiotensin-converting enzyme and&#xD;
      beta-blockers among other pharmaceutical and no pharmaceutical interventions. Aerobic&#xD;
      physical exercise, as a therapeutic intervention, reverses the physiopathological changes&#xD;
      that are presumed to lead to HF in sedentary people and it is known, it is feasible to&#xD;
      execute an exercise program in cancer patients. However, effective treatments for the primary&#xD;
      prevention of systolic dysfunction are not well known. Our hypothesis is that an aerobic&#xD;
      physical exercise program for at least 3 months, in subjects with lymphoma and new-onset&#xD;
      chemotherapy, is effective in preventing left ventricular systolic dysfunction, at the end of&#xD;
      chemotherapy and at one year. For this, the investigators propose a randomized, controlled,&#xD;
      clinical study which is blind both for the patient and the evaluating physician, comparing&#xD;
      the difference of global longitudinal strain (an echocardiographic result of myocardial&#xD;
      function) pre-chemotherapy minus end of chemotherapy and minus one year after, between the&#xD;
      active group (aerobic program) and the control group (flexibility program).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis: an aerobic physical exercise program for at least 3 months, in subjects with&#xD;
      hemato-oncological diseases that initiate chemotherapy, is effective in preventing systolic&#xD;
      dysfunction of the left ventricle at the end of chemotherapy and one year.&#xD;
&#xD;
      It is a double-blind, randomized controlled trial. Blinded for the subject, evaluating&#xD;
      echocardiographic, and treating hematologist.&#xD;
&#xD;
      Blocked randomization method stratified by sex: the randomization sequence will be software&#xD;
      generated and centralized by an investigator independent from assistant physicians and&#xD;
      echocardiographic evaluator.&#xD;
&#xD;
      To calculate N sample the investigators took a 15% variation of longitudinal left ventricular&#xD;
      strain ( clinically significant criteria). The mean and standard deviation of the healthy&#xD;
      Uruguayan population was taken from an own study (19.6 ± 1.7%); considering alpha error 0.05&#xD;
      and power 80%, a sample of 16 in each group is required to find significant results. An&#xD;
      additional 20% was added for possible &quot;drop outs&quot; resulting in a sample size of 19&#xD;
      subjects/group (N total 38).&#xD;
&#xD;
      The intervention is a 3 months aerobic exercise program compared with a 3 months flexibility&#xD;
      exercise program.&#xD;
&#xD;
      The main outcome is the myocardial longitudinal strain variation. Secondary outcomes are&#xD;
      related to systolic and diastolic cardiac function, quality of life, cardiac and oncological&#xD;
      outcomes, and evaluation of adherence.&#xD;
&#xD;
      Statistical analysis: Qualitative variables will be expressed in absolute and relative&#xD;
      frequency. Continuous variables will be resumed as mean and standard deviation or median and&#xD;
      interquartile interval regarding normal distribution. Parametric or non- parametric tests of&#xD;
      the association will be used regarding test of normality of each continuous outcome and&#xD;
      Chi-squared test for the association of qualitative variables. Survival analysis will be made&#xD;
      with Kaplan Meier curves and long rank test.&#xD;
&#xD;
      The project is registered in Uruguayan interventional trial registration (Ministery of Public&#xD;
      Health) with the number 812559.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 2, 2021</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</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>Active group: 3 months , 3 times/week aerobic program Control group: 3 months, 3 times/week flexibility program</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Both programs are equally planned related with time and number of sessions as well as clinical monitoring.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in GLS (exercise of flexibility and balance).</measure>
    <time_frame>6 months</time_frame>
    <description>GLS will be measured as the mean value of all segments pick systolic longitudinal strain expressed in percentage (%). The method will be speckle tracking, with a 4 MHz traducer and ViviIQ General Electric echocardiographer, The difference between GLS pre Chemotherapy minus post-chemotherapy and GLS pre chemotherapy minus a year after.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Left ventricular ejection fraction (LVEF)</measure>
    <time_frame>1 year</time_frame>
    <description>LVEF evaluated through Simpson biplane method, expressed in percentage. The value to compare will be those at the end of chemotherapy and a year after the beginning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GLS</measure>
    <time_frame>1 year</time_frame>
    <description>GLS evaluated through speckle tracking method, expressed in percentage. The value to compare will be those at the end of chemotherapy and a year after the beginning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiotoxicity incidense</measure>
    <time_frame>1 year</time_frame>
    <description>Cardiotoxicity definition: Decline of 10% or more of LVEF (pre chemotherapy value is the reference). Incidence of cardiotoxicity will be compared at the end of chemotherapy and one year after.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic function. E/e´index</measure>
    <time_frame>1 year</time_frame>
    <description>Pick value of E wave (pulse Doppler at the tip of mitral valve, first positive wave) and pick value of e´(mean of basal septal and basal lateral e´ , evaluated with tissue Doppler). The comparison will be done at the end of chemotherapy and 1 year from the beginning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic function. Left atrial GLS</measure>
    <time_frame>1 year</time_frame>
    <description>Biplane atrial GLS expressed in percentage (%). Method for estimation: speckle tracking. The comparison will be at the end of chemotherapy and 1 year from the beginning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic function. Left atrial volume.</measure>
    <time_frame>1 year</time_frame>
    <description>Biplane left atrial volume, through longitud-area method, expressed in ml. The comparison will be at the end of chemotherapy and 1 year from the beginning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac injury. Troponin I dosification.</measure>
    <time_frame>3 months</time_frame>
    <description>Dosification of troponin I value (ng/ml) between groups (data from Day 8 to 11 of third chem cycle)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical cardiovascular composite outcome</measure>
    <time_frame>1 year</time_frame>
    <description>Incidence of HF incomes and cardiovascular mortality during the follow-up year between groups. Comparison of survival free of events (Kaplan Meier curve and long rank test).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle corporal mass</measure>
    <time_frame>1 year</time_frame>
    <description>Percentage of muscle mass calculated through a bioimpedance balance. Comparison will be made baseline, at 3 months and a year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity. Monthly mean of steps.</measure>
    <time_frame>3 months</time_frame>
    <description>The monthly average of daily physical activity during the 3 months duration of the exercise program measured by steps of a physical activity wristband.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life. Minnesota LIVING WITH HEART FAILURE® Questionnaire (MLHFQ)</measure>
    <time_frame>3 months</time_frame>
    <description>Minnesota questionnaire for HF patients: It is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. The patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses. The response format ranges from 0 (none or not applicable), to 1(very little) to 5 (very much). The simple sum of the responses that ranges from 0 to 105 is a measurement of heart failure severity as indicated by its adverse effect on the respondent's life during the past month. The MLHFQ scores increase with the adverse impact of heart failure on the respondent's life. Evaluation made at the end of exercise program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life. Functional Assessment of Cancer Therapy (FACT)</measure>
    <time_frame>3 months</time_frame>
    <description>FACT-G (general) questionnaire for oncological patients.General quality of life instrument intended for use with a variety of chronic illness conditions. Originally validated in a general cancer population.Administration: Self Time to complete: 5 minutes. Number of items:27 Domains &amp; categories: 4 Name of categories/domains: Physical, social/family, emotional, and functional well-being. Scaling of items: Five-point scale from 0 (not at all) to 4 (very much). Evaluation made at the end of exercise program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dysnea</measure>
    <time_frame>3 months</time_frame>
    <description>PROMIS questionnarie for dysnea severity evaluation.The PROMIS Dyspnea Severity item bank assesses the severity of shortness of breath or difficulty breathing an adult experiences in response to various specific activities. Each activity is rated in terms of degree of dyspnea (no shortness of breath, mildly short of breath, moderately short of breath, severely short of breath) while engaging in the activity over the past 7 days, with higher scores reflecting greater levels of dyspnea. Respondents who indicate that they did not perform an activity in the past 7 days will not produce a score for that item. The bank includes 33 items.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Cardiotoxicity</condition>
  <condition>Systolic Dysfunction</condition>
  <condition>Exercise, Aerobic</condition>
  <arm_group>
    <arm_group_label>Aerobic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 months program, 3 times/week aerobic ambulatory program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Flexibility</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3 months program, 3 times/week flexibility ambulatory program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic exercise (experimental)</intervention_name>
    <description>3 times per week, 30 minutes each time. Entrance in heat: 8-10 min of joint mobility and / or the aerobic exercise in the main part at light intensity (OMNI 3-4) Main part: minimum 30 minutes, maximun 60 minutes. Intensity: moderate, guided by Talk Test and effort perception scale 5-6 OMNI. Type: aerobic, cycling or walking at home using a treadmill or exercise bike and / or cycling and walking outdoors according to the patient's possibilities and preferences. Return to calm: 5 min of aerobic physical activity of main part at mild intensity (OMNI 3-4), then static stretching. Pictures with each type of exercise will be offered and detailed explained.</description>
    <arm_group_label>Aerobic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Flexibility exercise (active comparator)</intervention_name>
    <description>Entrance in heat: 10 min of joint mobility. Main part: Minimum 30 minutes. Frequency: 3 times por week Intensity: The patient should be able to slowly stretch the muscle to a position of mild discomfort. Type: Static Stretch Time: 15-30 seconds 2 repetitions of each stretch Number of exercises: 12 . Pictures with each muscle group to exercise will be offered and detailed explained.</description>
    <arm_group_label>Flexibility</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 18 and 75 years old&#xD;
&#xD;
          -  New-onset chemotherapy&#xD;
&#xD;
          -  Lymphoma (Hodgkin or non-Hodgkin).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability or contraindication to moderate physical activity due to orthopedic cause or&#xD;
             general disease (excluding oncological).&#xD;
&#xD;
          -  Hemato-oncological pathology different from lymphomas.&#xD;
&#xD;
          -  Lymphomas not treated with anthracyclines&#xD;
&#xD;
          -  Non-sinus rhythm.&#xD;
&#xD;
          -  Poor echocardiographic window (inability to assess longitudinal strain in more than 4&#xD;
             segments).&#xD;
&#xD;
          -  Physically active subjects (practice aerobic exercise at least 30 minutes, 3 times /&#xD;
             week, 3 previous months).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lucia Florio, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de la Republica</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lucia Florio, MD MSc</last_name>
    <phone>+59899606694</phone>
    <email>lu.floriol@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vìctor Dayan, MD PhD</last_name>
    <phone>+59824871515</phone>
    <email>victor_dayan@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centro Cardiovascular Universitario-Hospital de Clínicas -FMED- UdelaR</name>
      <address>
        <city>Montevideo</city>
        <zip>11600</zip>
        <country>Uruguay</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucia Florio</last_name>
      <phone>+598 24871515</phone>
      <phone_ext>2020</phone_ext>
      <email>lu.floriol@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Victor Dayan</last_name>
      <phone>+598 24816367</phone>
      <email>victor_dayan@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Uruguay</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de la Republica</investigator_affiliation>
    <investigator_full_name>Lucía Florio</investigator_full_name>
    <investigator_title>Associate Professor Cardiology</investigator_title>
  </responsible_party>
  <keyword>cardiotoxicity</keyword>
  <keyword>systolic dysfunction</keyword>
  <keyword>exercise, aerobic</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>strain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiotoxicity</mesh_term>
    <mesh_term>Systolic Murmurs</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/NCT04476576
org study id: exercise and chemotherapy
nct id: NCT04476576
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Oncological diseases are the main cause of death in developed countries and also in Uruguay.
      Advances in therapeutics have made possible to aspire to cure and in other cases long-term
      remission with a significant increase in survival and the transformation of cancer into a
      chronic disease. Chemotherapy treatments have some side effects and cardiotoxicity is well
      known within them. Heart failure (HF) is a progressive pathology, with high mortality and
      high resource requirements of the health system with a prognosis that may be worse than some
      types of cancers. The treatment of established systolic dysfunction and symptomatic HF is
      mainly based on the indication of inhibitors of the angiotensin-converting enzyme and
      beta-blockers among other pharmaceutical and no pharmaceutical interventions. Aerobic
      physical exercise, as a therapeutic intervention, reverses the physiopathological changes
      that are presumed to lead to HF in sedentary people and it is known, it is feasible to
      execute an exercise program in cancer patients. However, effective treatments for the primary
      prevention of systolic dysfunction are not well known. Our hypothesis is that an aerobic
      physical exercise program for at least 3 months, in subjects with lymphoma and new-onset
      chemotherapy, is effective in preventing left ventricular systolic dysfunction, at the end of
      chemotherapy and at one year. For this, the investigators propose a randomized, controlled,
      clinical study which is blind both for the patient and the evaluating physician, comparing
      the difference of global longitudinal strain (an echocardiographic result of myocardial
      function) pre-chemotherapy minus end of chemotherapy and minus one year after, between the
      active group (aerobic program) and the control group (flexibility program).
Hypothesis: an aerobic physical exercise program for at least 3 months, in subjects with
      hemato-oncological diseases that initiate chemotherapy, is effective in preventing systolic
      dysfunction of the left ventricle at the end of chemotherapy and one year.

      It is a double-blind, randomized controlled trial. Blinded for the subject, evaluating
      echocardiographic, and treating hematologist.

      Blocked randomization method stratified by sex: the randomization sequence will be software
      generated and centralized by an investigator independent from assistant physicians and
      echocardiographic evaluator.

      To calculate N sample the investigators took a 15% variation of longitudinal left ventricular
      strain ( clinically significant criteria). The mean and standard deviation of the healthy
      Uruguayan population was taken from an own study (19.6 ± 1.7%); considering alpha error 0.05
      and power 80%, a sample of 16 in each group is required to find significant results. An
      additional 20% was added for possible "drop outs" resulting in a sample size of 19
      subjects/group (N total 38).

      The intervention is a 3 months aerobic exercise program compared with a 3 months flexibility
      exercise program.

      The main outcome is the myocardial longitudinal strain variation. Secondary outcomes are
      related to systolic and diastolic cardiac function, quality of life, cardiac and oncological
      outcomes, and evaluation of adherence.

      Statistical analysis: Qualitative variables will be expressed in absolute and relative
      frequency. Continuous variables will be resumed as mean and standard deviation or median and
      interquartile interval regarding normal distribution. Parametric or non- parametric tests of
      the association will be used regarding test of normality of each continuous outcome and
      Chi-squared test for the association of qualitative variables. Survival analysis will be made
      with Kaplan Meier curves and long rank test.

      The project is registered in Uruguayan interventional trial registration (Ministery of Public
      Health) with the number 812559.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Active group: 3 months , 3 times/week aerobic program Control group: 3 months, 3 times/week flexibility program
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Both programs are equally planned related with time and number of sessions as well as clinical monitoring.
measure: Change in GLS (exercise of flexibility and balance).
time frame: 6 months
description: GLS will be measured as the mean value of all segments pick systolic longitudinal strain expressed in percentage (%). The method will be speckle tracking, with a 4 MHz traducer and ViviIQ General Electric echocardiographer, The difference between GLS pre Chemotherapy minus post-chemotherapy and GLS pre chemotherapy minus a year after.
measure: Left ventricular ejection fraction (LVEF)
time frame: 1 year
description: LVEF evaluated through Simpson biplane method, expressed in percentage. The value to compare will be those at the end of chemotherapy and a year after the beginning.
measure: GLS
time frame: 1 year
description: GLS evaluated through speckle tracking method, expressed in percentage. The value to compare will be those at the end of chemotherapy and a year after the beginning.
measure: Cardiotoxicity incidense
time frame: 1 year
description: Cardiotoxicity definition: Decline of 10% or more of LVEF (pre chemotherapy value is the reference). Incidence of cardiotoxicity will be compared at the end of chemotherapy and one year after.
measure: Diastolic function. E/e´index
time frame: 1 year
description: Pick value of E wave (pulse Doppler at the tip of mitral valve, first positive wave) and pick value of e´(mean of basal septal and basal lateral e´ , evaluated with tissue Doppler). The comparison will be done at the end of chemotherapy and 1 year from the beginning.
measure: Diastolic function. Left atrial GLS
time frame: 1 year
description: Biplane atrial GLS expressed in percentage (%). Method for estimation: speckle tracking. The comparison will be at the end of chemotherapy and 1 year from the beginning.
measure: Diastolic function. Left atrial volume.
time frame: 1 year
description: Biplane left atrial volume, through longitud-area method, expressed in ml. The comparison will be at the end of chemotherapy and 1 year from the beginning.
measure: Cardiac injury. Troponin I dosification.
time frame: 3 months
description: Dosification of troponin I value (ng/ml) between groups (data from Day 8 to 11 of third chem cycle)
measure: Clinical cardiovascular composite outcome
time frame: 1 year
description: Incidence of HF incomes and cardiovascular mortality during the follow-up year between groups. Comparison of survival free of events (Kaplan Meier curve and long rank test).
measure: Muscle corporal mass
time frame: 1 year
description: Percentage of muscle mass calculated through a bioimpedance balance. Comparison will be made baseline, at 3 months and a year.
measure: Physical activity. Monthly mean of steps.
time frame: 3 months
description: The monthly average of daily physical activity during the 3 months duration of the exercise program measured by steps of a physical activity wristband.
measure: Quality of life. Minnesota LIVING WITH HEART FAILURE® Questionnaire (MLHFQ)
time frame: 3 months
description: Minnesota questionnaire for HF patients: It is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. The patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses. The response format ranges from 0 (none or not applicable), to 1(very little) to 5 (very much). The simple sum of the responses that ranges from 0 to 105 is a measurement of heart failure severity as indicated by its adverse effect on the respondent's life during the past month. The MLHFQ scores increase with the adverse impact of heart failure on the respondent's life. Evaluation made at the end of exercise program.
measure: Quality of life. Functional Assessment of Cancer Therapy (FACT)
time frame: 3 months
description: FACT-G (general) questionnaire for oncological patients.General quality of life instrument intended for use with a variety of chronic illness conditions. Originally validated in a general cancer population.Administration: Self Time to complete: 5 minutes. Number of items:27 Domains & categories: 4 Name of categories/domains: Physical, social/family, emotional, and functional well-being. Scaling of items: Five-point scale from 0 (not at all) to 4 (very much). Evaluation made at the end of exercise program.
measure: Dysnea
time frame: 3 months
description: PROMIS questionnarie for dysnea severity evaluation.The PROMIS Dyspnea Severity item bank assesses the severity of shortness of breath or difficulty breathing an adult experiences in response to various specific activities. Each activity is rated in terms of degree of dyspnea (no shortness of breath, mildly short of breath, moderately short of breath, severely short of breath) while engaging in the activity over the past 7 days, with higher scores reflecting greater levels of dyspnea. Respondents who indicate that they did not perform an activity in the past 7 days will not produce a score for that item. The bank includes 33 items.
arm group label: Aerobic
arm group type: Experimental
description: 3 months program, 3 times/week aerobic ambulatory program.
arm group label: Flexibility
arm group type: Active Comparator
description: 3 months program, 3 times/week flexibility ambulatory program
intervention type: Behavioral
intervention name: Aerobic exercise (experimental)
description: 3 times per week, 30 minutes each time. Entrance in heat: 8-10 min of joint mobility and / or the aerobic exercise in the main part at light intensity (OMNI 3-4) Main part: minimum 30 minutes, maximun 60 minutes. Intensity: moderate, guided by Talk Test and effort perception scale 5-6 OMNI. Type: aerobic, cycling or walking at home using a treadmill or exercise bike and / or cycling and walking outdoors according to the patient's possibilities and preferences. Return to calm: 5 min of aerobic physical activity of main part at mild intensity (OMNI 3-4), then static stretching. Pictures with each type of exercise will be offered and detailed explained.
arm group label: Aerobic
intervention type: Behavioral
intervention name: Flexibility exercise (active comparator)
description: Entrance in heat: 10 min of joint mobility. Main part: Minimum 30 minutes. Frequency: 3 times por week Intensity: The patient should be able to slowly stretch the muscle to a position of mild discomfort. Type: Static Stretch Time: 15-30 seconds 2 repetitions of each stretch Number of exercises: 12 . Pictures with each muscle group to exercise will be offered and detailed explained.
arm group label: Flexibility
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Lucia Florio, MD MSc
role: Principal Investigator
affiliation: Universidad de la Republica
last name: Lucia Florio, MD MSc
phone: +59899606694
email: lu.floriol@gmail.com
last name: Vìctor Dayan, MD PhD
phone: +59824871515
email: victor_dayan@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Uruguay
responsible party type: Sponsor-Investigator
investigator affiliation: Universidad de la Republica
investigator full name: Lucía Florio
investigator title: Associate Professor Cardiology
mesh term: Cardiotoxicity
mesh term: Systolic Murmurs
sharing ipd: No