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Completed

NCT Number: NCT03603743

High Intensity Interval Training vs Moderate Intensity and Continuous Training in Chronic Heart Failure

Purpose: Exaggerated sympathetic nervous system (SNS) activity associated with low heart rate variability (HRV) is considered as a trigger of cardiac arrhythmias and sudden death. Regular exercise training is efficient to improve autonomic balance. In 2013, the investigators published that a single session of an optimized short-high intensity interval exercise with passive recovery (HIIT) protocol was efficient in chronic heart failure (CHF) patients for enhancing vagal tone and to decrease arrhythmias in the 24-h post exercise period when compared to a single session of moderate intensity continuous exercise (MICT). Nevertheless the effects of HIIT training performed on several weeks have never yet been studied on the parameters described by Coumel's triangle (the arrhythmogenic substrate, the trigger factor as premature ventricular contraction and the modulation factors of which the most common is the autonomic nervous system). The aim of this study was to verify the superiority of HIIT to enhance parasympathetic activity, cardiorespiratory fitness and cardiac function when compared to MICT in a short and intense cardiac rehabilitation program.

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Key information

Conditions

Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Before and after the Rehabilitation Program (RP), all patients underwent a 24-hour ECG recording, an echocardiography, a cardiopulmonary exercise test.

The RP consisted of 2 types of exercise training according to the randomization:

  • a short-high intensity interval exercise with passive recovery
  • a classical moderate and continuous exercise training at 60% of peak power output

The RP lasted 4 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • stable chronic heart failure with NYHA functional class from I to III
  • stable left ventricular ejection fraction (LVEF) < 45% over at least 6 months
  • stable optimal medical therapy including a beta-blocker and an angiotensin-converting enzyme inhibitor or angiotensin receptor blockers for at least 6 weeks
  • ability to perform a maximal cardiopulmonary exercise test
  • admitted to the Rehabilitation Centre for a comprehensive Cardiovascular Rehabilitation Program

Exclusion criteria

  • any relative or absolute contraindications to exercise training according to current recommendations
  • fixed-rate pacemaker with heart rate limits set lower than exercise training target
  • major cardiovascular event or procedure within the 3 months preceding enrolment
  • chronic atrial fibrillation
  • heart failure secondary to significant uncorrected primary valve disease (except for mitral regurgitation secondary to left ventricular dysfunction)
  • heart failure secondary to congenital heart disease or obstructive cardiomyopathy.

Treatment and study plan

exercise training in heart failure with HIIT

Behavioral

to compare MICT vs HIIT 5 days/week during 4 weeks in a Cardiovascular Centre.

Primary outcomes

  1. High Frequency power in normalized units (HFnu%)

    Time frame: Change from baseline through study completion, an average of 4 weeks (measured during the night period for stationary signal)

    based on Heart Rate Variability, the power spectral density of the HF (0.15-0.40 Hz, ms2.Hz-1) bands were calculated.

Secondary outcomes

  1. maximal oxygen consumption (VO2peak ml.min.kg)

    Time frame: Change from baseline through study completion, an average of 4 weeks

    VO2 at peak exercise was measured with Cardiopulmonary Exercise Test.

  2. First ventilatory threshold (VT1) (ml.min.kg)

    Time frame: Change from baseline through study completion, an average of 4 weeks

    VO2 at VT1 was measured with Cardiopulmonary Exercise Test.

  3. Heart Rate Recovery (beats per minute, bpm)

    Time frame: Change from baseline through study completion, an average of 4 weeks

    Heart Rate Recovery (with passive recovery) at 1, 2 and 3 minutes after peak exercise (in beats per minute, bpm)

  4. Left Ventricular Ejection Fraction (LVEF, %)

    Time frame: Change from baseline through study completion, an average of 4 weeks

    LV volumes and ejection fraction were calculated from apical recordings by modified biplane Simpson's method.

  5. premature ventricular contraction, (n/24h)

    Time frame: Change from baseline through study completion, an average of 4 weeks

    Ectopic ventricular beats were classified as isolated premature contractions, bigeminy, and salves.

  6. NT-pro-BNP, (ng/L)

    Time frame: Change from baseline through study completion, an average of 4 weeks

    blood sample analysis

Sponsors and collaborators

Lead sponsor

Cardiovascular and Pulmonary Rehabilitation Center of Saint Orens

Other

Collaborators

  • Clinique Pasteur
  • Institut National de la Santé Et de la Recherche Médicale, France
  • University Hospital, Toulouse

Registry information

Official study title

Efficacy of High Intensity Interval Training vs Moderate Intensity and Continuous Training on Autonomic Nervous System Modulations in Chronic Heart Failure

Acronym: HRVFIT2

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 27, 2018
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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