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

NCT ID: NCT03603743

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-07
• Study Completion Date: 2017-10-13

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

exercise training in heart failure with HIIT

Intervention Type: BEHAVIORAL

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

moderate intensity and continuous exercise

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

Group Type: ACTIVE_COMPARATOR

exercise training in heart failure with HIIT

Intervention Type: BEHAVIORAL

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

Interventions

exercise training in heart failure with HIIT

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: collaborator

Clinique Pasteur

OTHER

Sponsor Role: collaborator

Cardiovascular and Pulmonary Rehabilitation Center of Saint Orens

OTHER

Sponsor Role: lead

Responsible Party

Lisa RICHARD, MD

Principal Investigator, Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Richard, MD

Role: PRINCIPAL_INVESTIGATOR

Clinic of Saint-Orens, Cardiovascular and Pulmonary Rehabilitation Center, Saint-Orens-de-Gameville, France

Thibaut Guiraud, PhD

Role: STUDY_DIRECTOR

Institute of Cardiovascular and Metabolic Diseases, National Institute of Health and Medical Research (INSERM), UMR-1048, Toulouse, France

Florent Besnier, PhD

Role: STUDY_CHAIR

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

References

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.

Reference Type: DERIVED

PMID: 31352063 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

2-15-12

Identifier Type: -

Identifier Source: org_study_id