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High-Intensity Interval Training Recuperates Capacity of Endogenous Thrombin Generation in Patients With Heart Failure

Primary Purpose

Heart Failure, High-intensity Interval Training

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HIIT
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring heart failure, exercise, microparticles, thrombin

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The HF was diagnosed if the patients had a left ventricular ejection fraction (LVEF) <40%.
  • All HF patients were New York Heart Association (NYHA) functional class II or III and had received optimal treatment for at least 12 months according to American Heart Association/American College of Cardiology guidelines.

Exclusion Criteria:

  • Patients with the presence of atrial fibrillation/flutter, second/third degree heart block, history of life-threatening ventricular arrhythmias, recent unstable angina, myocardial infarction or coronary revascularization (<4 weeks), uncontrolled diabetes mellitus, severe chronic obstructive pulmonary disease, or symptomatic cerebral vascular disease within 12 months, collagen vascular disease, alcohol or drug abuse during the previous 12 months or significant renal or hepatic disease were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    High intensity-interval training (HIIT)

    normal counterparts

    Arm Description

    The HF group performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 3 days/week for 12 weeks

    gender-matched normal counterparts (NC) did not receive any form of intervention

    Outcomes

    Primary Outcome Measures

    Microparticles derived from blood cells and shedding endothelial cells
    Platelet-poor plasma (PPP) was separated from whole blood by centrifugation at 1,600g for 10 min at room temperature. The quantification of microparticles in PPP was determined by a three-color FACScan flow cytometer.

    Secondary Outcome Measures

    Cardiopulmonary fitness
    evaluate cardiac hemodynamic response to exercise by noninvasive continuous cardiac output monitoring system

    Full Information

    First Posted
    July 24, 2019
    Last Updated
    July 24, 2019
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04033523
    Brief Title
    High-Intensity Interval Training Recuperates Capacity of Endogenous Thrombin Generation in Patients With Heart Failure
    Official Title
    High-Intensity Interval Training Recuperates Capacity of Endogenous Thrombin Generation in Patients With Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2, 2013 (Actual)
    Primary Completion Date
    July 1, 2016 (Actual)
    Study Completion Date
    July 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Consumptive coagulopathy is associated with increased mortality in patients with heart failure (HF). Physical activity influences the risk of major vascular thrombotic events. This study investigates how high-intensity interval training (HIIT) affects the capacity of endogenous thrombin generation (TG) by modulating circulatory procoagulant microparticles (MPs) in HF patients. Thirty-eight HF patients and 38 age- and gender-matched normal counterparts (NC) were recruited into this study. The HF group performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 3 days/week for 12 weeks, whereas the NC group did not receive any form of intervention. Plasma TG kinetics, procoagulant MPs, coagulation-related factors, and oxidative stress/proinflammatory status were analyzed. The results demonstrated that the HF group exhibited (i) less endogenous thrombin potential (ETP) and TG rate, (ii) lower concentration/activity of tissue factor (TF) and counts of TF-rich MPs derived from blood cells, and (iiii) higher vascular endothelial shedding and plasma myeloperoxidase and interleukin-6 concentrations, compared to the NC group did. However, HIIT elevated plasma ETP and TG rate, as well as, TF concentration/activity and blood cell-derived procoagulant MP levels in the HF patients. Moreover, the exercise regimen also decreased vascular endothelial shedding and plasma myeloperoxidase and interleukin-6 concentrations in patients with HF. Hence, we conclude that HF reduces the capacity of endogenous TG in plasma, which is associated with decreased (or consumed) circulatory procoagulant MP levels. However, HIIT alleviates HF-declined endogenous TG capacity and vascular endothelial damage through recuperating TF-related coagulation activity and suppressing oxidative stress/proinflammatory status.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, High-intensity Interval Training
    Keywords
    heart failure, exercise, microparticles, thrombin

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    High intensity-interval training (HIIT)
    Arm Type
    Experimental
    Arm Description
    The HF group performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 3 days/week for 12 weeks
    Arm Title
    normal counterparts
    Arm Type
    No Intervention
    Arm Description
    gender-matched normal counterparts (NC) did not receive any form of intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    HIIT
    Intervention Description
    The HF group performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 3 days/week for 12 weeks
    Primary Outcome Measure Information:
    Title
    Microparticles derived from blood cells and shedding endothelial cells
    Description
    Platelet-poor plasma (PPP) was separated from whole blood by centrifugation at 1,600g for 10 min at room temperature. The quantification of microparticles in PPP was determined by a three-color FACScan flow cytometer.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Cardiopulmonary fitness
    Description
    evaluate cardiac hemodynamic response to exercise by noninvasive continuous cardiac output monitoring system
    Time Frame
    12 weeks
    Other Pre-specified Outcome Measures:
    Title
    Thrombin generation assay
    Description
    PPP was measure the rate of thrombin generation using the calibrated automated thrombogram (CAT) assay (Synapse/Thrombinoscope BV).
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The HF was diagnosed if the patients had a left ventricular ejection fraction (LVEF) <40%. All HF patients were New York Heart Association (NYHA) functional class II or III and had received optimal treatment for at least 12 months according to American Heart Association/American College of Cardiology guidelines. Exclusion Criteria: Patients with the presence of atrial fibrillation/flutter, second/third degree heart block, history of life-threatening ventricular arrhythmias, recent unstable angina, myocardial infarction or coronary revascularization (<4 weeks), uncontrolled diabetes mellitus, severe chronic obstructive pulmonary disease, or symptomatic cerebral vascular disease within 12 months, collagen vascular disease, alcohol or drug abuse during the previous 12 months or significant renal or hepatic disease were excluded.

    12. IPD Sharing Statement

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