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Chronic Heart FailurePROVO2MAXNCT03955029

Interval Training in Heart Failure

A study testing Progressive Interval training and Conventional Interval training in people with Chronic Heart Failure, run by University Hospital, Montpellier at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Heart failure (HF) is currently considered a common pathology, with 15 million adults in Europe and 26 million worldwide. The American Heart Association (AHA) estimates that their number will increase by 25% by 2030. In France, HF affects more than one million people. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Heart Failure
What is being tested?
Progressive Interval training and Conventional Interval training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
10 Jan 2020to 10 Jan 2025
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with chronic systolic heart failure (LVEF <40%)
  • men or women
  • 40 years patients or older
  • Patients admitted on cardiac rehabilitative medical prescription
  • Patients with a functional capacity of 6 Mets or less
  • Patients having given their free and informed consent to the study.

Who cannot join

  • Contraindication to rehabilitation,
  • Refusal of the patient to participation in the study
  • impaired comprehension
  • inability to perform the cyclometer
  • participation in another therapeutic protocol simultaneously

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • CHU Montpellier

    Montpellier, 34295

    Christophe HEDON, MDPHD, +33(0)4 67 33 53 78, c-hedon@chu-montpellier.fr

    Recruiting

Other trials in France

About this study

Official title: Effects of Progressive Interval Training on V02 Max in Chronic Heart Failure Patients

Heart failure (HF) is currently considered a common pathology, with 15 million adults in Europe and 26 million worldwide. The American Heart Association (AHA) estimates that their number will increase by 25% by 2030. In France, HF affects more than one million people. Because of the repeated hospitalizations of this disease, it is considered a costly pathology and with a high mortality rate (23.000 deaths per year in France). Moreover, HF is a severe pathology that affects the quality of life of patients and their families. Treatment and medical follow-up are required.

A cardiac rehabilitation program is also a primary indication according to the latest recommendations and repositories in Cardiology. Various studies show that "Interval Training" exercise program improves VO2 peak compared to a "continuous" program, which constitutes a major prognostic factor in the population of heart failure. However, it is sometimes a difficult program to offer to more deconditioned patients as it requires reaching powers around 80% - 95% of its maximum exertion capacity. So, a variant of the interval training is offered, called Progressive Interval Training (PIT), based on the same model as the conventional interval training (CIT), but with an increasing power and breathing threshold, so that the patient can adapt gradually.

The hypothesis is that PIT could improve VO2 peak better than CIT in cardiac rehabilitation program. Therefore, study the benefits of PIT training to improve the conditioning and quality of life of patients with chronic heart failure will be studied.

Read the detailed description

Chronic Heart Failure (CHF) is due to structural or functional cardiac anomalies which causes a lack of oxygen perfusion to various organs provoking symptoms as dyspnea, fatigue, palpitation at rest or during efforts. International prevalence is 1-2% in adult population, wich represents 15 million people in Europe and 26 millions in the world. In France, CHF represents the first cause of hospitalization. The rate of intra-hospital mortality is 8.2 % and the mortality in 1 year is 26 % according to the study OFICA in 2013. Its treatment is first medication.

Cardiac rehabilitation programs are also proposed. According to the latest recommendations of the European Society of Cardiology in 2016, patient education on diet, medical treatment observance and facilitation of psychosocial assistance with access to a multidisciplinary team, will reduce the rate of hospitalization and mortality (level of evidence IA). Similarly, the regular practice of an aerobic-type activity will increase the patient's functional capacity and improve the symptoms related to the disease. In the same way, the risk of re-hospitalization will be reduced (level of evidence IA). Cardiac rehabilitation of CHF patients includes a so-called "segmentary analytics" rehabilitation based on strength exercises and aerobic-type endurance work. This classical program is called "continuous" training in which the patient must exert on a cycloergometer or walking on a treadmill between 60% and 70% of his maximum exertion capacity, evaluated with initial VO2 max exercise test, before cardiac rehabilation. More recently, a new form of rehabilation mode appeared: "Interval Training" (IT) inspired by high level athletes training. It is a training model that alternates periods of intensity between 60%-95% of maximum effort (depending on the modality) and periods of passive or active rest between 20-30% of maximum effort. IT is more suitable for endurance work in CHF patients than continuous training. Indeed, this type of exercise has a muscular impact, in terms of strength, superior to that brought by continuous training without significantly increasing cardiac work or hemodynamic and metabolic parameters. Some studies show the effectiveness of both types of programms (continuous or IT) on improving the 6 minute walk test distance (6MWD) and displacing the first ventilatory threshold (VT1) for higher intensities. However, the interval training has a better effect than continuous program: 19.4% versus 8.3% for 6MWD improvement and 95% versus 75% for heart peak rate gain.

Nevertheless, it have been observed in daily practice that classical conventional IT (CIT) program could be difficult to perform in most of CHF patients, due to the severity of their pathology, poor physical condition and especially muscle deconditioning. Indeed, this deconditioning is linked to the sedentary behaviour of this type of patient because of the specific symptoms of his cardiac pathology, which will result in severe intolerance to effort. In Cardiac rehabilitation department of Montpellier University Hospital, a new type of IT program for severe CHF patients have been tested, with progressive intervals of maximum effort and active rest periods, called the Progressive Interval Training (PIT) program. After 6 months of applying this training model to our patients, it seems to be effective in endurance gain in final exercise test and without side-effects in terms of safety. The objective is to compare the 2 types of IT workouts (CIT and PIT) in 2 different randomized groups, on the improvement of VO2 peak in patients with severe CHF. Secondary ojectives are the imporvemnt on 6MWD, life quality and ventilatory threshold at the end of rehabilitation (VT1).

A typical session for a patient takes place in two parts: the first one with analytical segmentary rehabilitation exercises identical in terms of the muscular group worked and the number of series and repetitions and adapted (charge in kg) to each patient, and a second one of endurance aerobic work with conventional interval training (CIT) program or progressive interval training (PIT) program according to the randomized groups.

  • CIT intervention consists in: warming 7 minutes at 15 watts, then alternating exercices phases at 30% of maximum power (reached by patient at initial VO2 maximal exercise test realized before cardiac rehabilation) during 3 minutes and peak at 60% of maximum watts during 1 minute, then return to calm 3 minutes at 15 watts. Total duration of the endurance session is 30 minutes. The power in watts of the peak work will be shaped according to the Borg (if 6, increase of 5 watt the value of each peak at the next session).
  • PIT intervention consists in: warming 7 minutes at 15 watts, then alternating exercices phases at 30% watts of maximum power (reached by patient at initial VO2 maximal exercise test realized before cardiac rehabilation) during 3 minutes, a first peak work at 40% of maximum power, a second at 45%, a third at 50%, a fourth at 55% and a fifth at 60%, then return to calm 3 minutes at 15 watts. Total duration of this endurance session is also 30 minutes. The peak powers will be shaped according to the Borg (if 6, increase of 5 watt the value of each peak to the next session).

Each patient conducts a total of 20 sessions at a rate of 2 sessions per week. It is a monocentric, controlled, randomized, prospective study with two parallel groups (open except for the evaluation which will be blind). The sample size is estimated at 50 subjects. Inclusion criteria are patients with CHF (left ventricular ejection fraction <40%), men or women over 60 years of age, admitted on a cardiac rehabilation medical, with a functional capacity of less than 5 Mets, all of whom have their free and informed consent for the study.

The benefits to the patient are those related to Cardiovascular Rehabilitation that increase its functional capacity while improving its quality of life.

If the effectiveness of PIT program on improving aerobic capacity (VO2 max), functional abilities (VT1, TDM6 ') and/or quality of life is demonstrated, this program could be recommended for cardiac rehabilitation in patients with severe CHF. A larger number of patients could benefit from this program which takes into account the muscular deconditioning related to their pathology.

Being tested
Progressive Interval training, Conventional Interval training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive Interval trainingOther

    heating up 7 minutes at 15 watt, then alternating 30% of the maximum power reached by the patient at Vo2 max for 3 minutes and first peak at 40% of max power, second at 45%, third at 50%, fourth at 55 % and fifth to 60%, then return to calm 3 minutes at 15 watt. Total duration of the endurance session: 30 minutes. The powers of the peak will be modeled according to the Borg (if <6, increase by 5 watt the value of each peak at the next session).

  • Conventional Interval trainingOther

    warm up 7 minutes at 15 watt, then alternating between plateau at 30% of the max power reached by the patient at VO2 max for 3 minutes and peak at 60% for 1 minute, return to calm 3 minutes at 15 watts. Total duration of the endurance session: 30 minutes. The power of the peak will be modeled according to the Borg (if <6, increase by 5 watt the value of each peak at the next session)

Study groups in NCT03955029
Study groupRoleWhat they receive
Conventional Interval trainingExperimentalIt is a split-type workout that alternates periods of intensity between 60% -95% of the maximum effort (depending on the modality) and periods of passive or active rest between 20-30% of the maximum effort. The experimental group will follow conventional Interval Training
Receives: Other: Conventional Interval training
Progressive Interval trainingExperimentalIt is a split-type workout that alternates periods of intensity between 60% -95% of the maximum effort (depending on the modality) and periods of passive or active rest between 20-30% of the maximum effort. The experimental group will follow progressive Interval Training
Receives: Other: Progressive Interval training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VO² peak in patients with cardiac heart failure

    Evaluate the effectiveness of endurance rehabilitation program with climbing of ladders (PIT) versus an endurance rehabilitation program with conventional interval training on improving VO² peak in patients with CHF

    Measured: Baseline

  2. VO² peak in patients with cardiac heart failure

    Evaluate the effectiveness of endurance rehabilitation program with climbing of ladders (PIT) versus an endurance rehabilitation program with conventional interval training on improving VO² peak in patients with CHF

    Measured: 12 weeks

Secondary outcomes (2)
  1. Questionnary Short Form Health Survey

    Questionnary Short Form Health Survey (SF-36)

    Measured: Baseline

  2. Questionnary Short Form Health Survey

    Questionnary Short Form Health Survey (SF-36)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2019
  2. Study start10 Jan 2020
  3. Primary completion10 Jan 2025 (estimated)
  4. Study completion10 Jan 2025 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03955029
Sponsor's protocol ID
RECHMPL18_0229
Acronym
PROVO2MAX
Status last verified
Jan 2024
First submitted
5 Apr 2019
Last updated
17 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Progressive Interval training and Conventional Interval training in people with Chronic Heart Failure, run by University Hospital, Montpellier at 1 site in France.

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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VO² peak in patients with cardiac heart failure (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Jan 2024.

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