<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/NCT03013270</url>
  </required_header>
  <id_info>
    <org_study_id>ARISTOS-HF</org_study_id>
    <nct_id>NCT03013270</nct_id>
  </id_info>
  <brief_title>Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure</brief_title>
  <acronym>ARISTOS-HF</acronym>
  <official_title>Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure. The ARISTOS-HF Trial: a Prospective Randomized Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Onassis Cardiac Surgery Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Asklepieion Voulas General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Cardiology, Warsaw, Poland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Onassis Cardiac Surgery Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the effects of aerobic, resistance, inspiratory training modalities&#xD;
      outcomes in functional capacity and quality of life of heart failure (HF) patients, aiming&#xD;
      for the 'optimum' (greek, αριστος=aristos) training program for HF patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart failure is a clinical syndrome characterized by symptoms of dyspnea, exercise&#xD;
      intolerance and decreased quality of life. A weakness in both inspiratory and peripheral&#xD;
      muscles is also reported. Aerobic training (AT) improves the functional status of HF patients&#xD;
      (level of evidence IA). Additional benefits of inspiratory muscle training (IMT) and/or&#xD;
      resistance training (RT) when combined with aerobic training (AT) in HF symptoms have also&#xD;
      been found.&#xD;
&#xD;
      Four exercise groups will be studied in order to identify the optimum exercise program I.&#xD;
      Aerobic-Resistance-Inspiratory training (ARIS) group II. Aerobic Training-Resistance Training&#xD;
      (AT/RT) group III. Aerobic training-Inspiratory Muscle Training (AT/IMT) group IV. Aerobic&#xD;
      Training (AT) group&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">May 2020</completion_date>
  <primary_completion_date type="Actual">August 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>change in peak oxygen consumption (peakVO2, in ml/kg/min) using cardiopulmonary exercise testing (Medgraphics CPX/MAX, Medical Graphics Corp.,St. Paul, MN, USA, ZAN 600, ZAN Messgera¨te GmbH, Germany)</measure>
    <time_frame>Before and after 12 weeks</time_frame>
    <description>evaluation of maximal exercise capacity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in left ventricular dimension (mm) using resting 2-dimensional echocardiography (Ultrasound Vivid 7 or 6, General Electric Healthcare, Fairfield, CT, USA) with the Teichholz method</measure>
    <time_frame>Before and after 12 weeks</time_frame>
    <description>evaluation of cardiac structure (LVEDD, LVESD in mm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in walking distance using the 6-minute walking test (6MWT)</measure>
    <time_frame>Before and after 12 weeks</time_frame>
    <description>evaluation of submaximal exercise capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in quality of Life using the Minnesota Living with Heart Failure questionnaire</measure>
    <time_frame>Before and after 12 weeks</time_frame>
    <description>evaluation of life quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preference Program Survey</measure>
    <time_frame>After 12 weeks</time_frame>
    <description>Questionnaire to evaluate exercise program preference (most enjoyed program) using a scale from 1 (=Very Little) to 5 (=Excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in left ventricular ejection fraction, echocardiography (Ultrasound Vivid 7 or 6, General Electric Healthcare, Fairfield, CT, USA) with the biplane Simpson' s method</measure>
    <time_frame>Before and after 12 weeks</time_frame>
    <description>evaluation of LVEF%</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in dyspnoea using the Borg scale (0-10) at the end of exercise testing</measure>
    <time_frame>Before and after 12 weeks</time_frame>
    <description>evaluation of dyspnea</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in maximal inspiratory pressure (PImax in cmH2O) using an electronic pressure manometer with computer software (TRAINAIR®, Project Electronics Ltd, London, UK).</measure>
    <time_frame>Before and after 12 weeks</time_frame>
    <description>evaluation of inspiratory muscle strength</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in inspiratory work capacity (sustained maximal inspiratory pressure (SPImax in cmH2O/s) using an electronic pressure manometer with computer software (TRAINAIR®, Project Electronics Ltd, London, UK).</measure>
    <time_frame>Before and after 12 weeks</time_frame>
    <description>evaluation of an inspiratory muscle endurance index</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in skeletal muscle strength will be evaluated using the quadriceps 1 repetition maximum (1RM)</measure>
    <time_frame>Before and after 12 weeks</time_frame>
    <description>evaluation of skeletal muscle strength</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in skeletal muscle endurance will be evaluated using the quadriceps muscle endurance with the product: 50%1Repetition Maximum x max number of reps</measure>
    <time_frame>Before and after 12 weeks</time_frame>
    <description>evaluation of skeletal muscle endurance</description>
  </other_outcome>
  <other_outcome>
    <measure>Morbidity Records</measure>
    <time_frame>6 months and 12 months after completion of Exercise Programs</time_frame>
    <description>Evaluate Morbidity</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>ARIS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic-Resistance-Inspiratory</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AT/RT group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aerobic-Resistance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AT/IMT group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aerobic-Inspiratory</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AT group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aerobic Training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic-Resistance-Inspiratory</intervention_name>
    <description>Patients will be submitted to a 12 week, 3 times/week, continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with resistance training at an intensity of 50% of 1 Repetition Maximum (1RM) for quads training and upper limb exercises (elbow flex/shoulder flex/abd) using dumbbells (1-2 kg) (12-15 reps/3sets) for 10 min, combined also with inspiratory muscle training with a flow-resistive loading system at an intensity of 60% of maximal inspiratory pressure/sustained maximal inspiratory pressure (PImax/SPImax) for 20 min (Aerobic (30min) + Resistance (10min) + Inspiratory (20min) = 60 min)</description>
    <arm_group_label>ARIS group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic-Resistance</intervention_name>
    <description>Patients will be submitted to a 12 week, 3 times/week, continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with resistance training at an intensity of 50% of 1RM for quads training, pectoralis m, serratus anterior m, and latissimus dorsi m and upper limb exercises (elbow flex/shoulder flex/abd) using dumbbells (1-2 kg) (12-15 reps/3sets).&#xD;
(Aerobic (30min) + Resistance (30min) = 60 min)</description>
    <arm_group_label>AT/RT group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic-Inspiratory</intervention_name>
    <description>Patients will be submitted to a 12 week, 3 times/week, continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with inspiratory muscle training with a flow-resistive loading system at an intensity of 60% of maximal inspiratory pressure/sustained maximal inspiratory pressure (PImax/SPImax) for 30min (Aerobic (30min) + Inspiratory (30min) = 60 min)</description>
    <arm_group_label>AT/IMT group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic Training</intervention_name>
    <description>Patients will be submitted to a 12 week, 3 times/week continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with callisthenics progressing to treadmill or bike (at the same intensity) for 30 min (Aerobic training = 60 min)</description>
    <arm_group_label>AT group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic heart failure (from New York Heart Association (NYHA) functional class II to&#xD;
             NYHA III)&#xD;
&#xD;
          -  Left ventricular ejection fraction below or equal to 35%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled arrhythmia&#xD;
&#xD;
          -  Pulmonary oedema or pulmonary congestion in the last 30 days&#xD;
&#xD;
          -  Cognitive, neurological or orthopaedic limitations&#xD;
&#xD;
          -  Respiratory infection during 30 days before the start of the study&#xD;
&#xD;
          -  Pulmonary limitations (e.g COPD)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stamatis Adamopoulos, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Onassis Cardiac Surgery Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Onassis Cardiac Surgery Center</name>
      <address>
        <city>Athens</city>
        <state>Attica</state>
        <zip>176 74</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepieion Voulas General Hospital</name>
      <address>
        <city>Voula</city>
        <state>Attica</state>
        <zip>16673</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Telecardiology Center, Institute of Cardiology</name>
      <address>
        <city>Warsaw</city>
        <zip>04-828</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Laoutaris ID, Adamopoulos S, Manginas A, Panagiotakos DB, Kallistratos MS, Doulaptsis C, Kouloubinis A, Voudris V, Pavlides G, Cokkinos DV, Dritsas A. Benefits of combined aerobic/resistance/inspiratory training in patients with chronic heart failure. A complete exercise model? A prospective randomised study. Int J Cardiol. 2013 Sep 1;167(5):1967-72. doi: 10.1016/j.ijcard.2012.05.019. Epub 2012 May 31.</citation>
    <PMID>22658571</PMID>
  </reference>
  <reference>
    <citation>Adamopoulos S, Schmid JP, Dendale P, Poerschke D, Hansen D, Dritsas A, Kouloubinis A, Alders T, Gkouziouta A, Reyckers I, Vartela V, Plessas N, Doulaptsis C, Saner H, Laoutaris ID. Combined aerobic/inspiratory muscle training vs. aerobic training in patients with chronic heart failure: The Vent-HeFT trial: a European prospective multicentre randomized trial. Eur J Heart Fail. 2014 May;16(5):574-82. doi: 10.1002/ejhf.70. Epub 2014 Mar 14.</citation>
    <PMID>24634346</PMID>
  </reference>
  <reference>
    <citation>Beckers PJ, Denollet J, Possemiers NM, Wuyts FL, Vrints CJ, Conraads VM. Combined endurance-resistance training vs. endurance training in patients with chronic heart failure: a prospective randomized study. Eur Heart J. 2008 Aug;29(15):1858-66. doi: 10.1093/eurheartj/ehn222. Epub 2008 May 30.</citation>
    <PMID>18515805</PMID>
  </reference>
  <reference>
    <citation>Smart NA. How do cardiorespiratory fitness improvements vary with physical training modality in heart failure patients? A quantitative guide. Exp Clin Cardiol. 2013 Winter;18(1):e21-5.</citation>
    <PMID>24294043</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>May 1, 2020</last_update_submitted>
  <last_update_submitted_qc>May 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Onassis Cardiac Surgery Centre</investigator_affiliation>
    <investigator_full_name>Laoutaris Ioannis</investigator_full_name>
    <investigator_title>PhD FESC</investigator_title>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>Exercise</keyword>
  <keyword>Training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT03013270
org study id: ARISTOS-HF
nct id: NCT03013270
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study investigates the effects of aerobic, resistance, inspiratory training modalities
      outcomes in functional capacity and quality of life of heart failure (HF) patients, aiming
      for the 'optimum' (greek, αριστος=aristos) training program for HF patients.
Heart failure is a clinical syndrome characterized by symptoms of dyspnea, exercise
      intolerance and decreased quality of life. A weakness in both inspiratory and peripheral
      muscles is also reported. Aerobic training (AT) improves the functional status of HF patients
      (level of evidence IA). Additional benefits of inspiratory muscle training (IMT) and/or
      resistance training (RT) when combined with aerobic training (AT) in HF symptoms have also
      been found.

      Four exercise groups will be studied in order to identify the optimum exercise program I.
      Aerobic-Resistance-Inspiratory training (ARIS) group II. Aerobic Training-Resistance Training
      (AT/RT) group III. Aerobic training-Inspiratory Muscle Training (AT/IMT) group IV. Aerobic
      Training (AT) group
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: change in peak oxygen consumption (peakVO2, in ml/kg/min) using cardiopulmonary exercise testing (Medgraphics CPX/MAX, Medical Graphics Corp.,St. Paul, MN, USA, ZAN 600, ZAN Messgera¨te GmbH, Germany)
time frame: Before and after 12 weeks
description: evaluation of maximal exercise capacity
measure: change in left ventricular dimension (mm) using resting 2-dimensional echocardiography (Ultrasound Vivid 7 or 6, General Electric Healthcare, Fairfield, CT, USA) with the Teichholz method
time frame: Before and after 12 weeks
description: evaluation of cardiac structure (LVEDD, LVESD in mm)
measure: change in walking distance using the 6-minute walking test (6MWT)
time frame: Before and after 12 weeks
description: evaluation of submaximal exercise capacity
measure: change in quality of Life using the Minnesota Living with Heart Failure questionnaire
time frame: Before and after 12 weeks
description: evaluation of life quality
measure: Preference Program Survey
time frame: After 12 weeks
description: Questionnaire to evaluate exercise program preference (most enjoyed program) using a scale from 1 (=Very Little) to 5 (=Excellent)
measure: change in left ventricular ejection fraction, echocardiography (Ultrasound Vivid 7 or 6, General Electric Healthcare, Fairfield, CT, USA) with the biplane Simpson' s method
time frame: Before and after 12 weeks
description: evaluation of LVEF%
measure: Change in dyspnoea using the Borg scale (0-10) at the end of exercise testing
time frame: Before and after 12 weeks
description: evaluation of dyspnea
measure: Change in maximal inspiratory pressure (PImax in cmH2O) using an electronic pressure manometer with computer software (TRAINAIR®, Project Electronics Ltd, London, UK).
time frame: Before and after 12 weeks
description: evaluation of inspiratory muscle strength
measure: Change in inspiratory work capacity (sustained maximal inspiratory pressure (SPImax in cmH2O/s) using an electronic pressure manometer with computer software (TRAINAIR®, Project Electronics Ltd, London, UK).
time frame: Before and after 12 weeks
description: evaluation of an inspiratory muscle endurance index
measure: Change in skeletal muscle strength will be evaluated using the quadriceps 1 repetition maximum (1RM)
time frame: Before and after 12 weeks
description: evaluation of skeletal muscle strength
measure: Change in skeletal muscle endurance will be evaluated using the quadriceps muscle endurance with the product: 50%1Repetition Maximum x max number of reps
time frame: Before and after 12 weeks
description: evaluation of skeletal muscle endurance
measure: Morbidity Records
time frame: 6 months and 12 months after completion of Exercise Programs
description: Evaluate Morbidity
arm group label: ARIS group
arm group type: Experimental
description: Aerobic-Resistance-Inspiratory
arm group label: AT/RT group
arm group type: Active Comparator
description: Aerobic-Resistance
arm group label: AT/IMT group
arm group type: Active Comparator
description: Aerobic-Inspiratory
arm group label: AT group
arm group type: Active Comparator
description: Aerobic Training
intervention type: Other
intervention name: Aerobic-Resistance-Inspiratory
description: Patients will be submitted to a 12 week, 3 times/week, continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with resistance training at an intensity of 50% of 1 Repetition Maximum (1RM) for quads training and upper limb exercises (elbow flex/shoulder flex/abd) using dumbbells (1-2 kg) (12-15 reps/3sets) for 10 min, combined also with inspiratory muscle training with a flow-resistive loading system at an intensity of 60% of maximal inspiratory pressure/sustained maximal inspiratory pressure (PImax/SPImax) for 20 min (Aerobic (30min) + Resistance (10min) + Inspiratory (20min) = 60 min)
arm group label: ARIS group
intervention type: Other
intervention name: Aerobic-Resistance
description: Patients will be submitted to a 12 week, 3 times/week, continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with resistance training at an intensity of 50% of 1RM for quads training, pectoralis m, serratus anterior m, and latissimus dorsi m and upper limb exercises (elbow flex/shoulder flex/abd) using dumbbells (1-2 kg) (12-15 reps/3sets).
(Aerobic (30min) + Resistance (30min) = 60 min)
arm group label: AT/RT group
intervention type: Other
intervention name: Aerobic-Inspiratory
description: Patients will be submitted to a 12 week, 3 times/week, continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with inspiratory muscle training with a flow-resistive loading system at an intensity of 60% of maximal inspiratory pressure/sustained maximal inspiratory pressure (PImax/SPImax) for 30min (Aerobic (30min) + Inspiratory (30min) = 60 min)
arm group label: AT/IMT group
intervention type: Other
intervention name: Aerobic Training
description: Patients will be submitted to a 12 week, 3 times/week continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with callisthenics progressing to treadmill or bike (at the same intensity) for 30 min (Aerobic training = 60 min)
arm group label: AT group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Stamatis Adamopoulos, MD
role: Study Chair
affiliation: Onassis Cardiac Surgery Center
facility: 
facility: 
facility: 
country: Greece
country: Poland
citation: Laoutaris ID, Adamopoulos S, Manginas A, Panagiotakos DB, Kallistratos MS, Doulaptsis C, Kouloubinis A, Voudris V, Pavlides G, Cokkinos DV, Dritsas A. Benefits of combined aerobic/resistance/inspiratory training in patients with chronic heart failure. A complete exercise model? A prospective randomised study. Int J Cardiol. 2013 Sep 1;167(5):1967-72. doi: 10.1016/j.ijcard.2012.05.019. Epub 2012 May 31.
PMID: 22658571
citation: Adamopoulos S, Schmid JP, Dendale P, Poerschke D, Hansen D, Dritsas A, Kouloubinis A, Alders T, Gkouziouta A, Reyckers I, Vartela V, Plessas N, Doulaptsis C, Saner H, Laoutaris ID. Combined aerobic/inspiratory muscle training vs. aerobic training in patients with chronic heart failure: The Vent-HeFT trial: a European prospective multicentre randomized trial. Eur J Heart Fail. 2014 May;16(5):574-82. doi: 10.1002/ejhf.70. Epub 2014 Mar 14.
PMID: 24634346
citation: Beckers PJ, Denollet J, Possemiers NM, Wuyts FL, Vrints CJ, Conraads VM. Combined endurance-resistance training vs. endurance training in patients with chronic heart failure: a prospective randomized study. Eur Heart J. 2008 Aug;29(15):1858-66. doi: 10.1093/eurheartj/ehn222. Epub 2008 May 30.
PMID: 18515805
citation: Smart NA. How do cardiorespiratory fitness improvements vary with physical training modality in heart failure patients? A quantitative guide. Exp Clin Cardiol. 2013 Winter;18(1):e21-5.
PMID: 24294043
responsible party type: Principal Investigator
investigator affiliation: Onassis Cardiac Surgery Centre
investigator full name: Laoutaris Ioannis
investigator title: PhD FESC
mesh term: Heart Failure
sharing ipd: No