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

Primary Purpose

Chronic Heart Failure

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

exercise training in heart failure with HIIT

About this trial

This is an interventional supportive care trial for Chronic Heart Failure focused on measuring exercise training, chronic heart failure, parasympathetic, autonomic nervous system, cardiorespiratory fitness, cardiac rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high intensity interval training

moderate intensity and continuous exercise

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

maximal oxygen consumption (VO2peak ml.min.kg)

VO2 at peak exercise was measured with Cardiopulmonary Exercise Test.

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

VO2 at VT1 was measured with Cardiopulmonary Exercise Test.

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)

Left Ventricular Ejection Fraction (LVEF, %)

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

premature ventricular contraction, (n/24h)

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

NT-pro-BNP, (ng/L)

blood sample analysis

Full Information

NCT ID

NCT03603743

First Posted

July 13, 2018

Last Updated

July 27, 2018

Sponsor

Cardiovascular and Pulmonary Rehabilitation Center of Saint Orens

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03603743

Brief Title

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

Acronym

HRVFIT2

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

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

May 7, 2015 (Actual)

Primary Completion Date

October 13, 2017 (Actual)

Study Completion Date

October 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cardiovascular and Pulmonary Rehabilitation Center of Saint Orens

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure

Keywords

exercise training, chronic heart failure, parasympathetic, autonomic nervous system, cardiorespiratory fitness, cardiac rehabilitation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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 1:1

Masking

InvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

high intensity interval training

Arm Type

Experimental

Arm Description

Arm Title

moderate intensity and continuous exercise

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

exercise training in heart failure with HIIT

Intervention Description

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

Primary Outcome Measure Information:

Title

High Frequency power in normalized units (HFnu%)

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

maximal oxygen consumption (VO2peak ml.min.kg)

Description

VO2 at peak exercise was measured with Cardiopulmonary Exercise Test.

Time Frame