HRVFIT2: High Intensity Interval Training vs Moderate Intensity and Continuous Training in Chronic Heart Failure

Sponsor

Cardiovascular and Pulmonary Rehabilitation Center of Saint Orens (Other)

Overall Status

Completed

CT.gov ID

NCT03603743

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other), University Hospital, Toulouse (Other), Clinique Pasteur (Other)

Enrollment

Arms

29.2

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure	Behavioral: exercise training in heart failure with HIIT	N/A

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:

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

subjects were randomly assigned to one of the two groups: high intensity interval training moderate intensity and continuous training Block size = 4, allocation ratio 1:1subjects were randomly assigned to one of the two groups: high intensity interval training moderate intensity and continuous training Block size = 4, allocation ratio 1:1

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

heart rate variability analyses and echocardiography were performed by investigators blind to randomization

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 7, 2015

Actual Primary Completion Date :

Oct 13, 2017

Actual Study Completion Date :

Oct 13, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: high intensity interval training high intensity interval training: two sets of 8-min intervals at 100% of peak power output (PPO). Each interval set was composed of repeated bouts of 30 s at 100% of PPO interspersed by 30 s of passive recovery in the seated position. Four minutes of passive recovery were allowed between the two sets.	Behavioral: exercise training in heart failure with HIIT to compare MICT vs HIIT 5 days/week during 4 weeks in a Cardiovascular Centre.
Active Comparator: moderate intensity and continuous exercise moderate intensity and continuous exercise: 30 minutes at 60% of PPO.	Behavioral: exercise training in heart failure with HIIT to compare MICT vs HIIT 5 days/week during 4 weeks in a Cardiovascular Centre.

Arm

Intervention/Treatment

Experimental: high intensity interval training

high intensity interval training: two sets of 8-min intervals at 100% of peak power output (PPO). Each interval set was composed of repeated bouts of 30 s at 100% of PPO interspersed by 30 s of passive recovery in the seated position. Four minutes of passive recovery were allowed between the two sets.

Behavioral: exercise training in heart failure with HIIT

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

Active Comparator: moderate intensity and continuous exercise

moderate intensity and continuous exercise: 30 minutes at 60% of PPO.

Behavioral: exercise training in heart failure with HIIT

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

Outcome Measures

Primary Outcome Measures

High Frequency power in normalized units (HFnu%) [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 Outcome Measures

maximal oxygen consumption (VO2peak ml.min.kg) [Change from baseline through study completion, an average of 4 weeks]
VO2 at peak exercise was measured with Cardiopulmonary Exercise Test.
First ventilatory threshold (VT1) (ml.min.kg) [Change from baseline through study completion, an average of 4 weeks]
VO2 at VT1 was measured with Cardiopulmonary Exercise Test.
Heart Rate Recovery (beats per minute, bpm) [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)
Left Ventricular Ejection Fraction (LVEF, %) [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.
premature ventricular contraction, (n/24h) [Change from baseline through study completion, an average of 4 weeks]
Ectopic ventricular beats were classified as isolated premature contractions, bigeminy, and salves.
NT-pro-BNP, (ng/L) [Change from baseline through study completion, an average of 4 weeks]
blood sample analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cardiovascular and Pulmonary Rehabilitation Center of Saint Orens
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Toulouse
Clinique Pasteur

Investigators

Principal Investigator: Lisa Richard, MD, Clinic of Saint-Orens, Cardiovascular and Pulmonary Rehabilitation Center, Saint-Orens-de-Gameville, France
Study Director: Thibaut Guiraud, PhD, Institute of Cardiovascular and Metabolic Diseases, National Institute of Health and Medical Research (INSERM), UMR-1048, Toulouse, France
Study Chair: Florent Besnier, PhD, 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