Clinical trial NCT03603743: High Intensity Interval Training vs Moderate Intensity and Continuous Training in Chronic Heart Failure
Official title: Efficacy of High Intensity Interval Training vs Moderate Intensity and Continuous Training on Autonomic Nervous System Modulations in Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: exercise training
chronic heart failure
parasympathetic
autonomic nervous system
cardiorespiratory fitness
cardiac rehabilitation
Lead sponsor: Cardiovascular and Pulmonary Rehabilitation Center of Saint Orens
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: University Hospital, Toulouse
name: Clinique Pasteur
First posted: 2018-07-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: subjects were randomly assigned to one of the two groups:

1. high intensity interval training
2. moderate intensity and continuous training Block size = 4, allocation ratio 1:1
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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:

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

The RP lasted 4 weeks.

Eligibility criteria: 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.

Primary outcomes:
measure: High Frequency power in normalized units (HFnu%)
timeFrame: Change from baseline through study completion, an average of 4 weeks (measured during the night period for stationary signal)
Secondary outcomes:
measure: maximal oxygen consumption (VO2peak ml.min.kg)
timeFrame: Change from baseline through study completion, an average of 4 weeks
measure: First ventilatory threshold (VT1) (ml.min.kg)
timeFrame: Change from baseline through study completion, an average of 4 weeks
measure: Heart Rate Recovery (beats per minute, bpm)
timeFrame: Change from baseline through study completion, an average of 4 weeks
measure: Left Ventricular Ejection Fraction (LVEF, %)
timeFrame: Change from baseline through study completion, an average of 4 weeks
measure: premature ventricular contraction, (n/24h)
timeFrame: Change from baseline through study completion, an average of 4 weeks
measure: NT-pro-BNP, (ng/L)
timeFrame: Change from baseline through study completion, an average of 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Clinic of Saint-Orens, Cardiovascular and Pulmonary Rehabilitation Center, Saint-Orens-de-Gameville, France
name: Lisa Richard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Cardiovascular and Metabolic Diseases, National Institute of Health and Medical Research (INSERM), UMR-1048, Toulouse, France
name: Thibaut Guiraud, PhD
role: STUDY_DIRECTOR
affiliation: Clinic of Saint-Orens, Cardiovascular and Pulmonary Rehabilitation Center, Saint-Orens-de-Gameville, France. / Institute of Cardiovascular and Metabolic Diseases, National Institute of Health and Medical Research (INSERM), UMR-1048, Toulouse, France
name: Florent Besnier, PhD
role: STUDY_CHAIR
References:
citation: Besnier F, Labrunee M, Richard L, Faggianelli F, Kerros H, Soukarie L, Bousquet M, Garcia JL, Pathak A, Gales C, Guiraud T, Senard JM. Short-term effects of a 3-week interval training program on heart rate variability in chronic heart failure. A randomised controlled trial. Ann Phys Rehabil Med. 2019 Sep;62(5):321-328. doi: 10.1016/j.rehab.2019.06.013. Epub 2019 Jul 25.