AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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:

  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.

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 groups in NCT03603743
Study groupRoleWhat they receive
high intensity interval trainingExperimentalhigh 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 exerciseActive comparatormoderate 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.

  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.

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

Secondary outcomes (6)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted27 Jul 2018
  2. Study start7 May 2015
  3. Primary completion13 Oct 2017
  4. Study completion13 Oct 2017

Resources

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)
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

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; AzTrials last refreshed its copy on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in