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

Chronic Heart Failure Clinical Trial

— HRVFIT2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603743
• Other study ID #: 2-15-12
• Status: Completed
• Phase: N/A
• Start date: May 7, 2015
• Est. completion date: October 13, 2017

Study information

• Verified date: July 2018
• Source: Cardiovascular and Pulmonary Rehabilitation Center of Saint Orens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 13, 2017
• Est. primary completion date: October 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Behavioral:
• exercise training in heart failure with HIIT
to compare MICT vs HIIT 5 days/week during 4 weeks in a Cardiovascular Centre.

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High Frequency power in normalized units (HFnu%)	based on Heart Rate Variability, the power spectral density of the HF (0.15-0.40 Hz, ms2.Hz-1) bands were calculated.	Change from baseline through study completion, an average of 4 weeks (measured during the night period for stationary signal)
Secondary	maximal oxygen consumption (VO2peak ml.min.kg)	VO2 at peak exercise was measured with Cardiopulmonary Exercise Test.	Change from baseline through study completion, an average of 4 weeks
Secondary	First ventilatory threshold (VT1) (ml.min.kg)	VO2 at VT1 was measured with Cardiopulmonary Exercise Test.	Change from baseline through study completion, an average of 4 weeks
Secondary	Heart Rate Recovery (beats per minute, bpm)	Heart Rate Recovery (with passive recovery) at 1, 2 and 3 minutes after peak exercise (in beats per minute, bpm)	Change from baseline through study completion, an average of 4 weeks
Secondary	Left Ventricular Ejection Fraction (LVEF, %)	LV volumes and ejection fraction were calculated from apical recordings by modified biplane Simpson's method.	Change from baseline through study completion, an average of 4 weeks
Secondary	premature ventricular contraction, (n/24h)	Ectopic ventricular beats were classified as isolated premature contractions, bigeminy, and salves.	Change from baseline through study completion, an average of 4 weeks
Secondary	NT-pro-BNP, (ng/L)	blood sample analysis	Change from baseline through study completion, an average of 4 weeks