<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/NCT03245125</url>
  </required_header>
  <id_info>
    <org_study_id>201601068B0</org_study_id>
    <nct_id>NCT03245125</nct_id>
  </id_info>
  <brief_title>HIIT Improves Survival of Heart Failure Patients</brief_title>
  <official_title>Impacts of High-intensity Interval Training on Long-term Survival of Heart Failure Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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>
      BACKGROUND Global burdens of heart failure (HF) are increasing in modern societies.&#xD;
      High-intensity interval training (HIIT) increases peak oxygen consumption (VO2peak) in HF&#xD;
      patients, which was hypothesized to improve the survival of HF patients.&#xD;
&#xD;
      OBJECTIVES The cohort study aimed to highlight the effect of HIIT on long-term survivals of&#xD;
      HF patients.&#xD;
&#xD;
      METHODS 329 HF patients, enrolled between 2009 and 2016, received multidisciplinary disease&#xD;
      management program (MDP). They had cardiopulmonary exercise test for peak exercise capacity&#xD;
      (VO2peak), echocardiographic examination for left ventricular ejection fraction (LVEF), LV&#xD;
      end-diastolic diameter (LVEDD), and LV end-systolic diameter (LVESD), b-type natriuretic&#xD;
      peptide (BNP), and quality of life questionnaire. HF patients with LVEF≤ 40% (HFrEF) and HF&#xD;
      patients with LVEF&gt; 40% (HFpEF) underwent≥ 36 times of HIIT. HFrEF and HFpEF patients were&#xD;
      classified as the MDP group. Generalized estimating equation (GEE) was used to estimate the&#xD;
      interaction between time and VO2peak, LVEF, LVEDD, LVESD, and BNP during the follow-up.&#xD;
      Survival analysis was conducted to assess effects of HIIT on the long-term survival of HF&#xD;
      during at end of the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2009</start_date>
  <completion_date type="Actual">April 30, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>all-cause death</measure>
    <time_frame>2009/1/1 to 2016/12/31</time_frame>
    <description>Any mortality during the study period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>all-cause re-admission</measure>
    <time_frame>2009/1/1 to 2016/12/31</time_frame>
    <description>Any re-admission during the study period</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">329</enrollment>
  <condition>Heart Failure</condition>
  <condition>Cardiac Rehabilitation</condition>
  <condition>Cardiac Remodeling, Ventricular</condition>
  <arm_group>
    <arm_group_label>HIIT subjects in HFrEF patients</arm_group_label>
    <description>heart failure patients with reduced ejection fraction (HFrEF) received at least 36 times of high-intensity interval training (HIIT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MDP subjects in HFrEF patients</arm_group_label>
    <description>heart failure patients with reduced ejection fraction (HFrEF) received only multidisciplinary disease management program (MDP) and underwent less than 36 times of high-intensity interval training (HIIT) or no exercise training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIIT subjects in HFpEF patients</arm_group_label>
    <description>heart failure patients with preserved ejection fraction (HFpEF) received at least 36 times of high-intensity interval training (HIIT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MDP subjects in HFpEF patients</arm_group_label>
    <description>heart failure patients with preserved ejection fraction (HFpEF) received only multidisciplinary disease management program (MDP) and underwent less than 36 times of high-intensity interval training (HIIT) or no exercise training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High-intensity interval training</intervention_name>
    <description>Patients warmed up for 3 min at 30% of peak oxygen consumption (VO2peak). Five 3-minute intervals at 80% of VO2peak and each interval was separated by 3-minute exercise at 40% of VO2peak. The exercise session was terminated by 3-minute cool-down at 30% of VO2peak. All subjects used a EKG and BP monitors as indicators of the assigned exercise intensity. Borg 6-to-20 scale was used to assess the rate of perceived exertion during and after each exercise session. Patients suffering unstable hemodynamic, ischemic cardiac symptoms/signs, and uncontrolled arrhythmia were instructed to immediately terminate exercise training.</description>
    <arm_group_label>HIIT subjects in HFpEF patients</arm_group_label>
    <arm_group_label>HIIT subjects in HFrEF patients</arm_group_label>
    <arm_group_label>MDP subjects in HFpEF patients</arm_group_label>
    <arm_group_label>MDP subjects in HFrEF patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Baseline information of all eligible candidates, including age, gender, body mass index&#xD;
        (BMI), and disease duration were recorded. Serum low-density lipoprotein (LDL), creatinine&#xD;
        (Cre), high sensitivity C-reactive protein (hs-CRP), glycohemoglobin (Hba1c), and b-type&#xD;
        natriuretic peptide (BNP) were evaluated during the follow-up. Each blood sampling for BNP&#xD;
        analysis and short form-36 health survey (SF-36) of physical component score (PCS) and&#xD;
        mental component score (MCS) for qualities of life were performed just before each&#xD;
        cardiopulmonary exercise test and echocardiographic examination.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        From January 1st, 2009 to December 31st, 2016, HF patients, defined according to the&#xD;
        European society of cardiology, with stable clinical status greater than 4 weeks after&#xD;
        optimal treatment were enrolled in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Those, who were ≥ 80 years and &lt; 20 years, unable to perform exercise caused by other&#xD;
        non-cardiac disease, pregnant, future cardiac transplantation within 6 months,&#xD;
        uncompensated HF patients, pacemaker patients, and renal patients with estimated glomerular&#xD;
        filtration rate &lt; 30 ml/min/1.73m2, were not candidates in the study. Patients had absolute&#xD;
        contraindications for cardiopulmonary exercise test (CPET) and aerobic activities,&#xD;
        suggested by the American College of Sports Medicine (ACSM), were also excluded in the&#xD;
        study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chih-Chin Hsu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of PM&amp;R, Keelung Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <results_reference>
    <citation>Fu TC, Wang CH, Lin PS, Hsu CC, Cherng WJ, Huang SC, Liu MH, Chiang CL, Wang JS. Aerobic interval training improves oxygen uptake efficiency by enhancing cerebral and muscular hemodynamics in patients with heart failure. Int J Cardiol. 2013 Jul 15;167(1):41-50. doi: 10.1016/j.ijcard.2011.11.086. Epub 2011 Dec 22.</citation>
    <PMID>22197120</PMID>
  </results_reference>
  <results_reference>
    <citation>Lee MF, Chen WS, Fu TC, Liu MH, Wang JS, Hsu CC, Huang YY, Cherng WJ, Wang CH. Non-invasive cardiac index monitoring during cardiopulmonary functional testing provides additional prognostic value in patients after acute heart failure. Int Heart J. 2012;53(6):364-9. doi: 10.1536/ihj.53.364.</citation>
    <PMID>23258137</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</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 Failure</mesh_term>
    <mesh_term>Ventricular Remodeling</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03245125
org study id: 201601068B0
nct id: NCT03245125
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
BACKGROUND Global burdens of heart failure (HF) are increasing in modern societies.
      High-intensity interval training (HIIT) increases peak oxygen consumption (VO2peak) in HF
      patients, which was hypothesized to improve the survival of HF patients.

      OBJECTIVES The cohort study aimed to highlight the effect of HIIT on long-term survivals of
      HF patients.

      METHODS 329 HF patients, enrolled between 2009 and 2016, received multidisciplinary disease
      management program (MDP). They had cardiopulmonary exercise test for peak exercise capacity
      (VO2peak), echocardiographic examination for left ventricular ejection fraction (LVEF), LV
      end-diastolic diameter (LVEDD), and LV end-systolic diameter (LVESD), b-type natriuretic
      peptide (BNP), and quality of life questionnaire. HF patients with LVEF≤ 40% (HFrEF) and HF
      patients with LVEF> 40% (HFpEF) underwent≥ 36 times of HIIT. HFrEF and HFpEF patients were
      classified as the MDP group. Generalized estimating equation (GEE) was used to estimate the
      interaction between time and VO2peak, LVEF, LVEDD, LVESD, and BNP during the follow-up.
      Survival analysis was conducted to assess effects of HIIT on the long-term survival of HF
      during at end of the study.
observational model: Cohort
time perspective: Prospective
measure: all-cause death
time frame: 2009/1/1 to 2016/12/31
description: Any mortality during the study period
measure: all-cause re-admission
time frame: 2009/1/1 to 2016/12/31
description: Any re-admission during the study period
arm group label: HIIT subjects in HFrEF patients
description: heart failure patients with reduced ejection fraction (HFrEF) received at least 36 times of high-intensity interval training (HIIT)
arm group label: MDP subjects in HFrEF patients
description: heart failure patients with reduced ejection fraction (HFrEF) received only multidisciplinary disease management program (MDP) and underwent less than 36 times of high-intensity interval training (HIIT) or no exercise training
arm group label: HIIT subjects in HFpEF patients
description: heart failure patients with preserved ejection fraction (HFpEF) received at least 36 times of high-intensity interval training (HIIT)
arm group label: MDP subjects in HFpEF patients
description: heart failure patients with preserved ejection fraction (HFpEF) received only multidisciplinary disease management program (MDP) and underwent less than 36 times of high-intensity interval training (HIIT) or no exercise training
intervention type: Behavioral
intervention name: High-intensity interval training
description: Patients warmed up for 3 min at 30% of peak oxygen consumption (VO2peak). Five 3-minute intervals at 80% of VO2peak and each interval was separated by 3-minute exercise at 40% of VO2peak. The exercise session was terminated by 3-minute cool-down at 30% of VO2peak. All subjects used a EKG and BP monitors as indicators of the assigned exercise intensity. Borg 6-to-20 scale was used to assess the rate of perceived exertion during and after each exercise session. Patients suffering unstable hemodynamic, ischemic cardiac symptoms/signs, and uncontrolled arrhythmia were instructed to immediately terminate exercise training.
arm group label: HIIT subjects in HFpEF patients
arm group label: HIIT subjects in HFrEF patients
arm group label: MDP subjects in HFpEF patients
arm group label: MDP subjects in HFrEF patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Chih-Chin Hsu, MD, PhD
role: Principal Investigator
affiliation: Dept. of PM&R, Keelung Chang Gung Memorial Hospital
citation: Fu TC, Wang CH, Lin PS, Hsu CC, Cherng WJ, Huang SC, Liu MH, Chiang CL, Wang JS. Aerobic interval training improves oxygen uptake efficiency by enhancing cerebral and muscular hemodynamics in patients with heart failure. Int J Cardiol. 2013 Jul 15;167(1):41-50. doi: 10.1016/j.ijcard.2011.11.086. Epub 2011 Dec 22.
PMID: 22197120
citation: Lee MF, Chen WS, Fu TC, Liu MH, Wang JS, Hsu CC, Huang YY, Cherng WJ, Wang CH. Non-invasive cardiac index monitoring during cardiopulmonary functional testing provides additional prognostic value in patients after acute heart failure. Int Heart J. 2012;53(6):364-9. doi: 10.1536/ihj.53.364.
PMID: 23258137
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Ventricular Remodeling
sharing ipd: Undecided