Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Chronic Heart Failure
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

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 p...

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.

Tracking Information

NCT #
NCT03955029
Collaborators
Not Provided
Investigators
Not Provided