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

NCT03603743 | Completed

• 1 other identifier: 2-15-12
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• maximal oxygen consumption (VO2peak ml.min.kg)

  Change from baseline through study completion, an average of 4 weeks

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

  Change from baseline through study completion, an average of 4 weeks

• Heart Rate Recovery (beats per minute, bpm)

  Change from baseline through study completion, an average of 4 weeks

• Left Ventricular Ejection Fraction (LVEF, %)

  Change from baseline through study completion, an average of 4 weeks

• premature ventricular contraction, (n/24h)

  Change from baseline through study completion, an average of 4 weeks

Study Arms (2)

high intensity interval training

EXPERIMENTAL

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

moderate intensity and continuous exercise

ACTIVE COMPARATOR

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

Behavioral: exercise training in heart failure with HIIT

Interventions

exercise training in heart failure with HIIT BEHAVIORAL

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

high intensity interval training; moderate intensity and continuous exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 31352063 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lisa Richard, MD

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

  PRINCIPAL INVESTIGATOR

• Thibaut Guiraud, PhD

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

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: heart rate variability analyses and echocardiography were performed by investigators blind to randomization
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Cardiologist

Model Details: subjects were randomly assigned to one of the two groups: 1. high intensity interval training 2. moderate intensity and continuous training Block size = 4, allocation ratio 1:1

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 27, 2018
• Study Start: May 7, 2015
• Primary Completion: October 13, 2017
• Study Completion: October 13, 2017
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share