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

July 27, 2018 updated by: Lisa RICHARD, MD, Cardiovascular and Pulmonary Rehabilitation Center of Saint Orens

Efficacy of High Intensity Interval Training vs Moderate Intensity and Continuous Training on Autonomic Nervous System Modulations 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline through study completion, an average of 4 weeks (measured during the night period for stationary signal)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline through study completion, an average of 4 weeks
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.
Change from baseline through study completion, an average of 4 weeks
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)
Change from baseline through study completion, an average of 4 weeks
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.
Change from baseline through study completion, an average of 4 weeks
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.
Change from baseline through study completion, an average of 4 weeks
NT-pro-BNP, (ng/L)
Time Frame: Change from baseline through study completion, an average of 4 weeks
blood sample analysis
Change from baseline through study completion, an average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2015

Primary Completion (Actual)

October 13, 2017

Study Completion (Actual)

October 13, 2017

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

July 23, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

July 30, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-15-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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