Chronic Heart FailureHRVFIT2NCT03603743
High Intensity Interval Training vs Moderate Intensity and Continuous Training in Chronic Heart Failure
A study testing exercise training in heart failure with HIIT in people with Chronic Heart Failure, run by Cardiovascular and Pulmonary Rehabilitation Center of Saint Orens.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- exercise training in heart failure with HIIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2015to 13 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Heart Failure
- Being tested
- exercise training in heart failure with HIIT
- Keywords
- exercise training, chronic heart failure, parasympathetic, autonomic nervous system, cardiorespiratory fitness, cardiac rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise training in heart failure with HIITBehavioural
to compare MICT vs HIIT 5 days/week during 4 weeks in a Cardiovascular Centre.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: exercise training in heart failure with HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
VO2 at peak exercise was measured with Cardiopulmonary Exercise Test.
Measured: Change from baseline through study completion, an average of 4 weeks
First ventilatory threshold (VT1) (ml.min.kg)
VO2 at VT1 was measured with Cardiopulmonary Exercise Test.
Measured: Change from baseline through study completion, an average of 4 weeks
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)
Measured: Change from baseline through study completion, an average of 4 weeks
Left Ventricular Ejection Fraction (LVEF, %)
LV volumes and ejection fraction were calculated from apical recordings by modified biplane Simpson's method.
Measured: Change from baseline through study completion, an average of 4 weeks
premature ventricular contraction, (n/24h)
Ectopic ventricular beats were classified as isolated premature contractions, bigeminy, and salves.
Measured: Change from baseline through study completion, an average of 4 weeks
NT-pro-BNP, (ng/L)
blood sample analysis
Measured: Change from baseline through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start7 May 2015
- Primary completion13 Oct 2017
- Study completion13 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovascular and Pulmonary Rehabilitation Center of Saint Orens
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Toulouse, Clinique Pasteur
- Responsible party
- Principal investigator, Lisa RICHARD, MD, Cardiovascular and Pulmonary Rehabilitation Center of Saint Orens
- Investigators
- Lisa Richard, MD, Principal investigator, Clinic of Saint-Orens, Cardiovascular and Pulmonary Rehabilitation Center, Saint-Orens-de-Gameville, FranceThibaut Guiraud, PhD, Study director, Institute of Cardiovascular and Metabolic Diseases, National Institute of Health and Medical Research (INSERM), UMR-1048, Toulouse, FranceFlorent Besnier, PhD, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603743
- Sponsor's protocol ID
- 2-15-12
- Acronym
- HRVFIT2
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31352063
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Intensity Interval Training vs Moderate Intensity and Continuous Training on Autonomic Nervous System Modulations in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT03603743
- Acronym / sponsor ID
- HRVFIT2 / 2-15-12
- Conditions
- Chronic Heart Failure
- Keywords
- exercise training, chronic heart failure, parasympathetic, autonomic nervous system, cardiorespiratory fitness, cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cardiovascular and Pulmonary Rehabilitation Center of Saint OrensUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Toulouse, Clinique Pasteur
- Study start
- 7 May 2015 (actual)
- Primary completion
- 13 Oct 2017 (actual)
- Study completion
- 13 Oct 2017 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| high intensity interval training | Experimental | Behavioral: exercise training in heart failure with HIIThigh 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 | Active comparator | Behavioral: exercise training in heart failure with HIITmoderate intensity and continuous exercise: 30 minutes at 60% of PPO. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise training in heart failure with HIITto compare MICT vs HIIT 5 days/week during 4 weeks in a Cardiovascular Centre. | Behavioural | high intensity interval training, moderate intensity and continuous exercise |
Primary outcome
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.
6 secondary outcomes
maximal oxygen consumption (VO2peak ml.min.kg)
Time frame: 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
Heart Rate Recovery (beats per minute, bpm)
Time frame: 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
premature ventricular contraction, (n/24h)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Derived from this study: PubMed 31352063Besnier 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.
- Individual participant dataSharing planned: No
Related trials for Chronic Heart Failure
RecruitingObservational study
Voice-based Outcome Identification and Clinical Evaluation in Heart Failure
Heart Failure, Chronic Heart Failure
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
RecruitingPhase 3
Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre
Heart Failure
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Richard, MD principal investigator
Clinic of Saint-Orens, Cardiovascular and Pulmonary Rehabilitation Center, Saint-Orens-de-Gameville, France
Thibaut Guiraud, PhD study director
Institute of Cardiovascular and Metabolic Diseases, National Institute of Health and Medical Research (INSERM), UMR-1048, Toulouse, France
Florent Besnier, PhD 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
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in heart failure with HIIT in people with Chronic Heart Failure, run by Cardiovascular and Pulmonary Rehabilitation Center of Saint Orens.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03603743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.