Effect of Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- RT control group
研究概览
简要总结
Exercise is essential in cardiac rehabilitation for heart failure patients.Aerobic training and resistance training are both recommended. Resistance training improves muscle mass and strength and also improves the remodeling of cardiac function, thus reducing exercise intolerance in these patients. However, to obtain these adaptations, resistance training must be done at moderate to high intensities, which cannot always be sustained by the most fragile and deconditioned patients, such as those with reduced ejection fraction (Heart failure with reduced Ejection Fraction).
Blood flow restriction (BFR) by vascular occlusion training is an interesting alternative to conventional resistance training for these deconditioned patients. Preclinical and clinical studies have shown that, for low-intensity regimens, resistance training and blood flow restriction by vascular occlusion improves muscle strength and left ventricular function, unlike resistance training alone. Tissue hypoxemia, initiated by vascular occlusion and exacerbated by maintenance of exercise, is a key element in the peripheral adaptations documented in blood flow restriction, triggering a cascade of signaling pathways involving neurohumoral factors in particular, with effects both locally (i.e. striated skeletal muscle) and remotely, on the myocardium among others. The feasibility and safety of blood flow restriction in heart failure patients has been well demonstrated. Left ventricle ejection fraction remains a very global functional index, with poor reproducibility influenced by cardiac load conditions, making it impossible to draw any conclusions as to possible improvements in myocardial function, linked to changes in intrinsic tissue decontractility/relaxation properties. New cardiac imaging techniques like Speckle Tracking Echography have made it possible to assess the effects of blood flow resistance on myocardial function but so far no studies have used these tools to compare the effects of BFR+resistance training and resistance training alone on myocardial function in heart failure patients. It is suggested that resistance training combined with blood flow resistance could further improve cardiac and muscular function compared with resistance training alone, by activating neurohumoral mediators, like certain micro ribonucleic acids.
详细描述
Physical exercise is an essential part of cardiac rehabilitation for heart failure patients. In addition to aerobic training, resistance training is now recommended by scientific societies. Clinical studies report that resistance training contributes not only to peripheral reconditioning, with improved muscle mass and strength, but also to central reconditioning, with improved remodeling and cardiac function, thus reducing the exercise intolerance of heart failure patients. These favorable adaptations are achieved, however, on condition that RT is performed at moderate to high intensities (e.g. >75-80% of maximal repetition), intensities that cannot always be sustained by the most fragile and deconditioned patients, such as those with heart failure with reduced ejection fraction. The guidelines recommend intensities of 40% or less of repetition maximum.
Blood flow restriction (BFR) by vascular occlusion training is an interesting alternative to conventional resistance training, particularly for these most deconditioned patients. Preclinical and clinical studies have clearly established that for low-intensity regimens (around 40% of maximal repetition, an intensity well tolerated by the most fragile patients), resistance training+BFR improves muscle strength and left ventricular function, unlike resistance training alone. Tissue hypoxemia, initiated by vascular occlusion and exacerbated by maintenance of exercise, is a key element in the peripheral adaptations documented in BFR, triggering the activation of a cascade of signaling pathways involving neurohumoral factors in particular, with effects both locally (i.e. striated skeletal muscle) and remotely, on the myocardium among others. The feasibility and safety (i.e. no reported adverse events) of BFR in heart failure patients has been well demonstrated.
Left ventricular ejection fraction remains a very global functional index, with poor reproducibility and influenced by cardiac load conditions, making it impossible to draw any conclusions as to possible improvements in myocardial function, linked to changes in intrinsic tissue decontractility/relaxation properties. Innovative cardiac imaging techniques, such as Speckle Tracking Echography, now enable a detailed assessment of the effects of BFR on myocardial function. However, no study has yet used these tools to compare the effects of BFR+resistance training and resistance training alone on myocardial function in heart failure with reduced ejection patients. It is hypothetically suggested that resistance training combined with BFR could further improve cardiac and muscular function compared with resistance training alone, thanks to the activation of neurohumoral mediators, such as certain micro ribonucleic acids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The primary endpoint assessor is blinded to the group
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LVEF ≤ 50%
- •Patients with an indication for cardiovascular rehabilitation in the first stay or not (according to national recommendations, as soon as possible after an exacerbation or at any time in a patient with chronic heart failure) (Bigot et al., 2024)
- •No medical contraindication to physical activity
- •Patient has given free and informed consent and signed the consent form
- •Patient affiliated with or benefiting from a health insurance scheme
排除标准
- •Patient participating in another Category I interventional study, or having participated in another interventional study in the last month
- •Patient in an exclusion period determined by a previous study
- •Patient under court protection, guardianship or curatorship
- •Unable to provide informed consent, or patient refuses to sign consent form
- •Pregnant, parturient or breast-feeding patient
- •Moderate to severe peripheral arterial disease. Arterial Doppler scan for arterial stenosis, with measurement of femoral and distal flows.
- •Active or recent deep vein thrombosis. Check with venous Doppler ultrasound, looking for venous compressibility at the roots of the thighs, and 4-point venous ultrasound.
- •Medication known to alter the effects of ischemic conditioning (cyclosporine, glibenclamide).
- •Uncontrolled arterial hypertension
- •Severe valvular disease
研究组 & 干预措施
RT control group
Patients on resistance training only. Patients in this group will receive 4 weeks of cardiac rehabilitation with 6 sessions/week, 2 sessions of aerobic training on a cycloergometer and 4 sessions of resistance training
RT+BFR group
Patients on resistance training combined with blood flow restriction. Sessions will consist of 30 repetitions, followed by 3 sets of 15 repetitions at 40% 1-MR (maximal repetition), interspersed with 60 sec of recovery. An arterial occlusion pressure of 50% of systolic pressure will be maintained constant using a digital tourniquet. The cuff will be deflated during the recovery phases.
干预措施: Application of a vascular restriction device during resistance training (Device)
结局指标
主要结局
RT control group
时间窗: After 4 weeks of rehabilitation
Left ventricular global longitudinal strain (GLS), calculated from segmental longitudinal strains on apical 4-, 3-, and 2-chamber views using an 18-segment model (Voigt et al 2015).
BFR+RT group
时间窗: After 4 weeks of rehabilitation
Left ventricular global longitudinal strain (GLS), calculated from segmental longitudinal strains on apical 4-, 3-, and 2-chamber views using an 18-segment model (Voigt et al 2015).
RT control group
时间窗: Baseline
Left ventricular global longitudinal strain (GLS), calculated from segmental longitudinal strains on apical 4-, 3-, and 2-chamber views using an 18-segment model (Voigt et al 2015).
BFR+RT group
时间窗: Baseline
Left ventricular global longitudinal strain (GLS), calculated from segmental longitudinal strains on apical 4-, 3-, and 2-chamber views using an 18-segment model (Voigt et al 2015).
次要结局
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Myocardial work(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Myocardial work(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Mechanical dispersion(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Mechanical dispersion(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Cardiac index(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Tricuspid regurgitation flow(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: systolic pulmonary arterial pressure(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricle ejection fraction(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: E/E' and E/A ratio(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RTgroup: E/E' and E/A ratio(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Cardiac index(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Left atrial deformities(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Tricuspid regurgitation flow(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: systolic pulmonary arterial pressure(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: systolic pulmonary arterial pressure (mmHg)(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left atrial deformities(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricle ejection fraction(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: E/E' and E/A ratio(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left atrial deformities(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Mechanical dispersion(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: systolic pulmonary arterial pressure (mmHg)(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Atrial volume(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Vmax IT(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Vmax IT(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Atrial volume(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Myocardial work(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricular volume(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Myocardial work(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left atrial deformities(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Mechanical dispersion(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricular volume(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left ventricle ejection fraction(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left ventricle ejection fraction(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: E/E' and E/A ratio(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: E/E' and E/A ratio(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: cardiac index(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: cardiac index(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Tricuspid regurgitation flow(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Tricuspid regurgitation flow(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: systolic pulmonary arterial pressure(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: systolic pulmonary arterial pressure(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Vmax IT(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Vmax IT(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Atrial volume(After 4 weeks of rehabilitation)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Atrial volume(After 4 weeks of rehabilitation)
- (C) Stress test measurement in controls : peak oxygen consumption(After 4 weeks of rehabilitation)
- (C) Stress test measurement in the BFR+RT group : peak oxygen consumption(Baseline)
- (C) Stress test measurement in the BFR+RT group: peak oxygen consumption(After 4 weeks of rehabilitation)
- (C) Stress test measurement in controls : Maximum aerobic power(After 4 weeks of rehabilitation)
- (C) Stress test measurement in the BFR+RT group : Maximum aerobic power(After 4 weeks of rehabilitation)
- (C) Stress test measurement in controls : First ventilatory threshold(After 4 weeks of rehabilitation)
- (C) Stress test measurement in the BFR+RT group : First ventilatory threshold(After 4 weeks of rehabilitation)
- (C) Muscular evaluation in controls: Peak torque(After 4 weeks of rehabilitation)
- (C) Muscular evaluation in the BFR+RT group: Peak torque(After 4 weeks of rehabilitation)
- (C) Muscular evaluation in controls: Maximum repetition(After 4 weeks of rehabilitation)
- (C) Muscular evaluation in the BFR+RT group: Maximum repetition(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in controls: Body mass index(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in the BFR+RT group: Body mass index(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in controls: Waist circumference(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in the BFR+RT group: Waist circumference(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in controls: Lipid profile(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in the BFR+RT group: Lipid profile(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in controls: Glycated hemoglobin(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in the BFR+RT group: Glycated hemoglobin(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in controls: Fasting blood glucose(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in the BFR+RT group: Fasting blood glucose(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in controls: Pro-Brain Natriuretic Peptide(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in the BFR+RT group: Pro-Brain Natriuretic Peptide(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in controls: C-reactive protein(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in the BFR+RT group: C-reactive protein(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in controls: Micro ribonucleic acids(Baseline)
- (D) Clinical and biological measurement in the BFR+RT group: Micro ribonucleic acids(Baseline)
- (D) Clinical and biological measurement in controls: Micro ribonucleic acid(After 4 weeks of rehabilitation)
- (D) Clinical and biological measurement in the BFR+RT group: Micro ribonucleic acid(After 4 weeks of rehabilitation)
- (E) MacNew Heart Disease Quality of Life score in controls(After 4 weeks of rehabilitation)
- (E) MacNew Heart Disease Quality of Life score in the BFR+RT group(After 4 weeks of rehabilitation)
- (F) International Physical Activity Questionnaire in controls(After 4 weeks of rehabilitation)
- (F) International Physical Activity Questionnaire in the BFR+RT group(After 4 weeks of rehabilitation)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Myocardial work(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Myocardial work(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Left atrial deformities(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left atrial deformities(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Mechanical dispersion(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Mechanical dispersion(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricle ejection fraction(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricle ejection fraction(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: E/E' and E/A ratio(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Cardiac index(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Cardiac index(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Tricuspid regurgitation flow(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Tricuspid regurgitation flow(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Vmax IT(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Vmax IT(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricular volume(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricular volume(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the control group: Atrial volume(Baseline)
- (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Atrial volume(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Myocardial work(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Myocardial work(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left atrial deformities(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left atrial deformities(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Mechanical dispersion(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Mechanical dispersion(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left ventricle ejection fraction(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left ventricle ejection fraction(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: E/E' and E/A ratio(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: E/E' and E/A ratio(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: cardiac index(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: cardiac index(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Tricuspid regurgitation flow(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Tricuspid regurgitation flow(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: systolic pulmonary arterial pressure(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: systolic pulmonary arterial pressure(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Vmax IT(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Vmax IT(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Atrial volume(Baseline)
- (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Atrial volume(Baseline)
- (C) Stress test measurement in controls : peak oxygen consumption(Baseline)
- (C) Stress test measurement in controls : Maximum aerobic power(Baseline)
- (C) Stress test measurement in the BFR+RT group : Maximum aerobic power(Baseline)
- (C) Stress test measurement in controls : First ventilatory threshold(Baseline)
- (C) Stress test measurement in the BFR+RT group : First ventilatory threshold(Baseline)
- (C) Muscular evaluation in controls: Peak torque(Baseline)
- (C) Muscular evaluation in the BFR+RT group: Peak torque(Baseline)
- (C) Muscular evaluation in controls: Maximum repetition(Baseline)
- (C) Muscular evaluation in the BFR+RT group: Maximum repetition(Baseline)
- (D) Clinical and biological measurement in controls: Body mass index(Baseline)
- (D) Clinical and biological measurement in the BFR+RT group: Body mass index(Baseline)
- (D) Clinical and biological measurement in controls: Waist circumference(Baseline)
- (D) Clinical and biological measurement in the BFR+RT group: Waist circumference(Baseline)
- (D) Clinical and biological measurement in controls: Lipid profile(Baseline)
- (D) Clinical and biological measurement in the BFR+RT group: Lipid profile(Baseline)
- (D) Clinical and biological measurement in controls: Glycated hemoglobin(Baseline)
- (D) Clinical and biological measurement in the BFR+RT group: Glycated hemoglobin(Baseline)
- (D) Clinical and biological measurement in controls: Fasting blood glucose(Baseline)
- (D) Clinical and biological measurement in the BFR+RT group: Fasting blood glucose(Baseline)
- (D) Clinical and biological measurement in controls: Pro-Brain Natriuretic Peptide(Baseline)
- (D) Clinical and biological measurement in the BFR+RT group: Pro-Brain Natriuretic Peptide(Baseline)
- (D) Clinical and biological measurement in controls: C-reactive protein(Baseline)
- (D) Clinical and biological measurement in the BFR+RT group: C-reactive protein(Baseline)
- (E) MacNew Heart Disease Quality of Life score in controls(Baseline)
- (E) MacNew Heart Disease Quality of Life score in the BFR+RT group(Baseline)
- (F) International Physical Activity Questionnaire in controls(Baseline)
- (F) International Physical Activity Questionnaire in the BFR+RT group(Baseline)