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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT control group | No Intervention | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of a vascular restriction device during resistance training | Device | In the BFR-RT group, 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. In the control group (RT group) it will be the same intervention with same intensities but without using BFR. |
| Measure | Description | Time Frame |
|---|---|---|
| RT control group | 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). | Baseline |
| BFR+RT group | 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). | Baseline |
| RT control group | 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). | After 4 weeks of rehabilitation |
| BFR+RT group | 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). | After 4 weeks of rehabilitation |
| Measure | Description | Time Frame |
|---|---|---|
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Myocardial work | The global index (constructive work, lost work, and efficiency) will be measured in mmHg% | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Myocardial work |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clarisse BELVISI | Contact | +33466683459 | clarisse.belvisi@chu-nimes.fr | |
| Anissa MEGZARI | Contact | 0466684236 | drc@chu-nimes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christelle ROBERT, Dr. | Nîmes University Hospital | Study Director |
| Alice GAUTHIER, Dr. | Nîmes University Hospital | Principal Investigator |
| Clara GROMOFF, Dr. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nîmes University Hospital | Nîmes | Gard | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33611446 | Background | Ambrosetti M, Abreu A, Corra U, Davos CH, Hansen D, Frederix I, Iliou MC, Pedretti RFE, Schmid JP, Vigorito C, Voller H, Wilhelm M, Piepoli MF, Bjarnason-Wehrens B, Berger T, Cohen-Solal A, Cornelissen V, Dendale P, Doehner W, Gaita D, Gevaert AB, Kemps H, Kraenkel N, Laukkanen J, Mendes M, Niebauer J, Simonenko M, Zwisler AO. Secondary prevention through comprehensive cardiovascular rehabilitation: From knowledge to implementation. 2020 update. A position paper from the Secondary Prevention and Rehabilitation Section of the European Association of Preventive Cardiology. Eur J Prev Cardiol. 2021 May 14;28(5):460-495. doi: 10.1177/2047487320913379. | |
| 29596561 |
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Patients will be randomized into two groups : blood flow restriction+resistance training group (BFR+RT) or the resistance training control group (RT). Patients will receive 4 weeks of cardiac rehabilitation with 6 sessions/week, 2 sessions of aerobic training on a cycloergometer and 4 sessions of RT with or without BFR depending on the group.
Patients will be assessed at inclusion and at the end of the protocol by speckle tracking echocardiography, cardio-pulmonary test and muscular evaluation on isokinetic dynamometer.
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The primary endpoint assessor is blinded to the group
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The global index (constructive work, lost work, and efficiency) will be measured in mmHg% |
| Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Myocardial work | The global index (constructive work, lost work, and efficiency) will be measured in mmHg% | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Myocardial work | The global index (constructive work, lost work, and efficiency) will be measured in mmHg% | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Left atrial deformities | Left atrial deformities will be measured in % | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left atrial deformities | Left atrial deformities will be measured in % | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Left atrial deformities | Left atrial deformities will be measured in % | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left atrial deformities | Left atrial deformities will be measured in % | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Mechanical dispersion | Post-systolic contractions will be measured in mmHg% | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Mechanical dispersion | Post-systolic contractions will be measured in mmHg% | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Mechanical dispersion | Post-systolic contractions will be measured in mmHg% | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Mechanical dispersion | Post-systolic contractions will be measured in mmHg% | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricle ejection fraction | Left ventricle ejection fraction will be measured in % | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricle ejection fraction | Left ventricle ejection fraction will be measured in % | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricle ejection fraction | Left ventricle ejection fraction will be measured in % | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricle ejection fraction | Left ventricle ejection fraction will be measured in % | 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 | E/E' and E/A ratio will be measured | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: E/E' and E/A ratio | E/E' and E/A ratio will be measured | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: E/E' and E/A ratio | E/E' and E/A ratio will be measured | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RTgroup: E/E' and E/A ratio | E/E' and E/A ratio will be measured | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Cardiac index | Cardiac index will be measured in L/min/m2 | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Cardiac index | Cardiac index will be measured in L/min/m2 | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Cardiac index | Cardiac index will be measured in L/min/m2 | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Cardiac index | Cardiac index will be measured in L/min/m2 | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Tricuspid regurgitation flow | Tricuspid regurgitation flow will be measured in m/sec | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Tricuspid regurgitation flow | Tricuspid regurgitation flow will be measured in m/sec | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Tricuspid regurgitation flow | Tricuspid regurgitation flow will be measured in m/sec | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Tricuspid regurgitation flow | Tricuspid regurgitation flow will be measured in m/sec | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: systolic pulmonary arterial pressure | Systolic pulmonary arterial pressure will be measured in mmHg | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: systolic pulmonary arterial pressure | Systolic pulmonary arterial pressure will be measured in mmHg | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: systolic pulmonary arterial pressure (mmHg) | Systolic pulmonary arterial pressure will be measured in mmHg | 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) | Systolic pulmonary arterial pressure will be measured in mmHg | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Vmax IT | Vmax IT will be measured in m/sec | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Vmax IT | Vmax IT will be measured in m/sec | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Vmax IT | Vmax IT will be measured in m/sec | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Vmax IT | Vmax IT will be measured in m/sec | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricular volume | Left ventricular telesystolic and telediastolic volumes will be measured | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricular volume | Left ventricular telesystolic and telediastolic volumes will be measured | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricular volume | Left ventricular telesystolic and telediastolic volumes will be measured | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricular volume | Left ventricular telesystolic and telediastolic volumes will be measured | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Atrial volume | Atrial telesystolic and telediastolic volumes will be measured | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Atrial volume | Atrial telesystolic and telediastolic volumes will be measured | Baseline |
| (A) other parameters of left ventricular and atrial myocardial function in the control group: Atrial volume | Atrial telesystolic and telediastolic volumes will be measured | After 4 weeks of rehabilitation |
| (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Atrial volume | Atrial telesystolic and telediastolic volumes will be measured | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Myocardial work | The global index (constructive work, lost work, and efficiency) will be measured in mmHg% | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Myocardial work | The global index (constructive work, lost work, and efficiency) will be measured in mmHg% | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Myocardial work | The global index (constructive work, lost work, and efficiency) will be measured in mmHg% | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Myocardial work | The global index (constructive work, lost work, and efficiency) will be measured in mmHg% | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left atrial deformities | Left atrial deformities will be measured in % | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left atrial deformities | Left atrial deformities will be measured in % | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left atrial deformities | Left atrial deformities will be measured in % | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left atrial deformities | Left atrial deformities will be measured in % | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Mechanical dispersion | Post-systolic contractions will be measured in mmHg% | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Mechanical dispersion | Post-systolic contractions will be measured in mmHg% | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Mechanical dispersion | Post-systolic contractions will be measured in mmHg% | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Mechanical dispersion | Post-systolic contractions will be measured in mmHg% | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left ventricle ejection fraction | The left ventricle ejection fraction will be measured as a percentage | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left ventricle ejection fraction | The left ventricle ejection fraction will be measured as a percentage | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left ventricle ejection fraction | The left ventricle ejection fraction will be measured as a percentage | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left ventricle ejection fraction | The left ventricle ejection fraction will be measured as a percentage | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: E/E' and E/A ratio | The E/E' and E/A ratio will be measured | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: E/E' and E/A ratio | The E/E' and E/A ratio will be measured | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: E/E' and E/A ratio | The E/E' and E/A ratio will be measured | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: E/E' and E/A ratio | The E/E' and E/A ratio will be measured | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: cardiac index | Cardiac index will be measured in L/min/m2 | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: cardiac index | Cardiac index will be measured in L/min/m2 | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: cardiac index | Cardiac index will be measured in L/min/m2 | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: cardiac index | Cardiac index will be measured in L/min/m2 | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Tricuspid regurgitation flow | Tricuspid regurgitation flow will be measured in m/sec | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Tricuspid regurgitation flow | Tricuspid regurgitation flow will be measured in m/sec | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Tricuspid regurgitation flow | Tricuspid regurgitation flow will be measured in m/sec | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Tricuspid regurgitation flow | Tricuspid regurgitation flow will be measured in m/sec | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: systolic pulmonary arterial pressure | Systolic pulmonary arterial pressure will be measured in mmHg | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: systolic pulmonary arterial pressure | Systolic pulmonary arterial pressure will be measured in mmHg | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: systolic pulmonary arterial pressure | Systolic pulmonary arterial pressure will be measured in mmHg | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: systolic pulmonary arterial pressure | Systolic pulmonary arterial pressure will be measured in mmHg | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Vmax IT | Vmax IT will be measured in m/sec | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Vmax IT | Vmax IT will be measured in m/sec | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Vmax IT | Vmax IT will be measured in m/sec | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Vmax IT | Vmax IT will be measured in m/sec | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Atrial volume | Atrial telesystolic and telediastolic volumes will be measured | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Atrial volume | Atrial telesystolic and telediastolic volumes will be measured | Baseline |
| (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Atrial volume | Atrial telesystolic and telediastolic volumes will be measured | After 4 weeks of rehabilitation |
| (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Atrial volume | Atrial telesystolic and telediastolic volumes will be measured | After 4 weeks of rehabilitation |
| (C) Stress test measurement in controls : peak oxygen consumption | Peak oxygen consumption (VO2pic) will be measured in mL/min/kg | Baseline |
| (C) Stress test measurement in the BFR+RT group : peak oxygen consumption | Peak oxygen consumption (VO2pic) will be measured in mL/min/kg | Baseline |
| (C) Stress test measurement in controls : peak oxygen consumption | Peak oxygen consumption (VO2pic) will be measured in mL/min/kg | After 4 weeks of rehabilitation |
| (C) Stress test measurement in the BFR+RT group: peak oxygen consumption | Peak oxygen consumption (VO2pic) will be measured in mL/min/kg | After 4 weeks of rehabilitation |
| (C) Stress test measurement in controls : Maximum aerobic power | Maximum aerobic power will be measured in Watts
| Baseline |
| (C) Stress test measurement in the BFR+RT group : Maximum aerobic power | Maximum aerobic power will be measured in Watts
| Baseline |
| (C) Stress test measurement in controls : Maximum aerobic power | Maximum aerobic power will be measured in Watts
| After 4 weeks of rehabilitation |
| (C) Stress test measurement in the BFR+RT group : Maximum aerobic power | Maximum aerobic power will be measured in Watts
| After 4 weeks of rehabilitation |
| (C) Stress test measurement in controls : First ventilatory threshold | First ventilatory threshold will be measured in mL/min/kg | Baseline |
| (C) Stress test measurement in the BFR+RT group : First ventilatory threshold | First ventilatory threshold will be measured in mL/min/kg | Baseline |
| (C) Stress test measurement in controls : First ventilatory threshold | First ventilatory threshold will be measured in mL/min/kg | After 4 weeks of rehabilitation |
| (C) Stress test measurement in the BFR+RT group : First ventilatory threshold | First ventilatory threshold will be measured in mL/min/kg | After 4 weeks of rehabilitation |
| (C) Muscular evaluation in controls: Peak torque | Peak torque will be measured in Nm | Baseline |
| (C) Muscular evaluation in the BFR+RT group: Peak torque | Peak torque will be measured in Nm | Baseline |
| (C) Muscular evaluation in controls: Peak torque | Peak torque will be measured in Nm | After 4 weeks of rehabilitation |
| (C) Muscular evaluation in the BFR+RT group: Peak torque | Peak torque will be measured in Nm | After 4 weeks of rehabilitation |
| (C) Muscular evaluation in controls: Maximum repetition | Maximum repetition will be measured in kilograms | Baseline |
| (C) Muscular evaluation in the BFR+RT group: Maximum repetition | Maximum repetition will be measured in kilograms | Baseline |
| (C) Muscular evaluation in controls: Maximum repetition | Maximum repetition will be measured in kilograms | After 4 weeks of rehabilitation |
| (C) Muscular evaluation in the BFR+RT group: Maximum repetition | Maximum repetition will be measured in kilograms | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in controls: Body mass index | Body mass index will be measured in Kg/m2 | Baseline |
| (D) Clinical and biological measurement in the BFR+RT group: Body mass index | Body mass index will be measured in Kg/m2 | Baseline |
| (D) Clinical and biological measurement in controls: Body mass index | Body mass index will be measured in Kg/m2 | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in the BFR+RT group: Body mass index | Body mass index will be measured in Kg/m2 | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in controls: Waist circumference | Waist circumference will be measured in cm | Baseline |
| (D) Clinical and biological measurement in the BFR+RT group: Waist circumference | Waist circumference will be measured in cm | Baseline |
| (D) Clinical and biological measurement in controls: Waist circumference | Waist circumference will be measured in cm | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in the BFR+RT group: Waist circumference | Waist circumference will be measured in cm | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in controls: Lipid profile | Lipids will be measured in mmol/L | Baseline |
| (D) Clinical and biological measurement in the BFR+RT group: Lipid profile | Lipids will be measured in mmol/L | Baseline |
| (D) Clinical and biological measurement in controls: Lipid profile | Lipids will be measured in mmol/L | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in the BFR+RT group: Lipid profile | Lipids will be measured in mmol/L | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in controls: Glycated hemoglobin | Glycated hemoglobin will be measured as a % | Baseline |
| (D) Clinical and biological measurement in the BFR+RT group: Glycated hemoglobin | Glycated hemoglobin will be measured as a % | Baseline |
| (D) Clinical and biological measurement in controls: Glycated hemoglobin | Glycated hemoglobin will be measured as a % | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in the BFR+RT group: Glycated hemoglobin | Glycated hemoglobin will be measured as a % | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in controls: Fasting blood glucose | Fasting blood glucose will be measured in g/L | Baseline |
| (D) Clinical and biological measurement in the BFR+RT group: Fasting blood glucose | Fasting blood glucose will be measured in g/L | Baseline |
| (D) Clinical and biological measurement in controls: Fasting blood glucose | Fasting blood glucose will be measured in g/L | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in the BFR+RT group: Fasting blood glucose | Fasting blood glucose will be measured in g/L | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in controls: Pro-Brain Natriuretic Peptide | Pro-Brain Natriuretic Peptide will be measured in ng/L | Baseline |
| (D) Clinical and biological measurement in the BFR+RT group: Pro-Brain Natriuretic Peptide | Pro-Brain Natriuretic Peptide will be measured in ng/L | Baseline |
| (D) Clinical and biological measurement in controls: Pro-Brain Natriuretic Peptide | Pro-Brain Natriuretic Peptide will be measured in ng/L | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in the BFR+RT group: Pro-Brain Natriuretic Peptide | Pro-Brain Natriuretic Peptide will be measured in ng/L | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in controls: C-reactive protein | C-reactive protein will be measured in mg/L | Baseline |
| (D) Clinical and biological measurement in the BFR+RT group: C-reactive protein | C-reactive protein will be measured in mg/L | Baseline |
| (D) Clinical and biological measurement in controls: C-reactive protein | C-reactive protein will be measured in mg/L | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in the BFR+RT group: C-reactive protein | C-reactive protein will be measured in mg/L | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in controls: Micro ribonucleic acids | Micro ribonucleic acids will be measured in ng/µl | Baseline |
| (D) Clinical and biological measurement in the BFR+RT group: Micro ribonucleic acids | Micro ribonucleic acids will be measured in ng/µl | Baseline |
| (D) Clinical and biological measurement in controls: Micro ribonucleic acid | Micro ribonucleic acids will be measured in ng/µl | After 4 weeks of rehabilitation |
| (D) Clinical and biological measurement in the BFR+RT group: Micro ribonucleic acid | Micro ribonucleic acids will be measured in ng/µl | After 4 weeks of rehabilitation |
| (E) MacNew Heart Disease Quality of Life score in controls | The MacNew is a self-administered heart disease-specific health-related quality of life [HRQL] questionnaire which addresses 3 major HRQL domains: Emotional, Physical, and Social. Each domain contains 9 questions to be rated as 1 [not very important] to 5 [very important]. These domains can be combined to give a Global HRQL score | Baseline |
| (E) MacNew Heart Disease Quality of Life score in the BFR+RT group | The MacNew is a self-administered heart disease-specific health-related quality of life [HRQL] questionnaire which addresses 3 major HRQL domains: Emotional, Physical, and Social. Each domain contains 9 questions to be rated as 1 [not very important] to 5 [very important]. These domains can be combined to give a Global HRQL score | Baseline |
| (E) MacNew Heart Disease Quality of Life score in controls | The MacNew is a self-administered heart disease-specific health-related quality of life [HRQL] questionnaire which addresses 3 major HRQL domains: Emotional, Physical, and Social. Each domain contains 9 questions to be rated as 1 [not very important] to 5 [very important]. These domains can be combined to give a Global HRQL score | After 4 weeks of rehabilitation |
| (E) MacNew Heart Disease Quality of Life score in the BFR+RT group | The MacNew is a self-administered heart disease-specific health-related quality of life [HRQL] questionnaire which addresses 3 major HRQL domains: Emotional, Physical, and Social. Each domain contains 9 questions to be rated as 1 [not very important] to 5 [very important]. These domains can be combined to give a Global HRQL score | After 4 weeks of rehabilitation |
| (F) International Physical Activity Questionnaire in controls | The International Physical Activity Questionnaire is intended for people aged 15 and over. The questionnaire assesses overall physical activity and sedentary time over the last seven days. The questionnaire looks at vigorous and moderate activity, walking, and time spent sitting (sedentary lifestyle), whether during leisure activities, at work, in daily life or during transport. There are several versions of the questionnaire, including a short one (7 questions) and a long one (27 questions), which people can self-administer or answer by telephone, for example. The questionnaire classifies the subject according to 3 levels of activity: inactive, moderate, high. | Baseline |
| (F) International Physical Activity Questionnaire in the BFR+RT group | The International Physical Activity Questionnaire is intended for people aged 15 and over. The questionnaire assesses overall physical activity and sedentary time over the last seven days. The questionnaire looks at vigorous and moderate activity, walking, and time spent sitting (sedentary lifestyle), whether during leisure activities, at work, in daily life or during transport. There are several versions of the questionnaire, including a short one (7 questions) and a long one (27 questions), which people can self-administer or answer by telephone, for example. The questionnaire classifies the subject according to 3 levels of activity: inactive, moderate, high. | Baseline |
| (F) International Physical Activity Questionnaire in controls | The International Physical Activity Questionnaire is intended for people aged 15 and over. The questionnaire assesses overall physical activity and sedentary time over the last seven days. The questionnaire looks at vigorous and moderate activity, walking, and time spent sitting (sedentary lifestyle), whether during leisure activities, at work, in daily life or during transport. There are several versions of the questionnaire, including a short one (7 questions) and a long one (27 questions), which people can self-administer or answer by telephone, for example. The questionnaire classifies the subject according to 3 levels of activity: inactive, moderate, high. | After 4 weeks of rehabilitation |
| (F) International Physical Activity Questionnaire in the BFR+RT group | The International Physical Activity Questionnaire is intended for people aged 15 and over. The questionnaire assesses overall physical activity and sedentary time over the last seven days. The questionnaire looks at vigorous and moderate activity, walking, and time spent sitting (sedentary lifestyle), whether during leisure activities, at work, in daily life or during transport. There are several versions of the questionnaire, including a short one (7 questions) and a long one (27 questions), which people can self-administer or answer by telephone, for example. The questionnaire classifies the subject according to 3 levels of activity: inactive, moderate, high. | After 4 weeks of rehabilitation |
| Nîmes University Hospital |
| Principal Investigator |
| Bertrand LEDERMANN, Dr. | Nîmes University Hospital | Principal Investigator |
| Philippe OBERT, Dr. | UFR Sciences Technologies Centre INRAE, Avignon | Principal Investigator |
| Background |
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| 34841727 | Background | Fayol A, Wack M, Livrozet M, Carves JB, Domenge O, Vermersch E, Mirabel M, Karras A, Le Guen J, Blanchard A, Azizi M, Amar L, Bories MC, Mousseaux E, Carette C, Puymirat E, Hagege A, Jannot AS, Hulot JS. Aetiological classification and prognosis in patients with heart failure with preserved ejection fraction. ESC Heart Fail. 2022 Feb;9(1):519-530. doi: 10.1002/ehf2.13717. Epub 2021 Nov 29. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided