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NCT Number: NCT07118410

Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Ventricular Function, Left

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nîmes University Hospital

Nîmes, Gard, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Resistance training

Primary outcomes

  1. RT control group

    Time frame: 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).

  2. BFR+RT group

    Time frame: 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).

  3. RT control group

    Time frame: 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).

  4. BFR+RT group

    Time frame: 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).

Secondary outcomes

  1. (A) other parameters of left ventricular and atrial myocardial function in the control group: Myocardial work

    Time frame: Baseline

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

  2. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Myocardial work

    Time frame: Baseline

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

  3. (A) other parameters of left ventricular and atrial myocardial function in the control group: Myocardial work

    Time frame: After 4 weeks of rehabilitation

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

  4. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Myocardial work

    Time frame: After 4 weeks of rehabilitation

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

  5. (A) other parameters of left ventricular and atrial myocardial function in the control group: Left atrial deformities

    Time frame: Baseline

    Left atrial deformities will be measured in %

  6. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left atrial deformities

    Time frame: Baseline

    Left atrial deformities will be measured in %

  7. (A) other parameters of left ventricular and atrial myocardial function in the control group: Left atrial deformities

    Time frame: After 4 weeks of rehabilitation

    Left atrial deformities will be measured in %

  8. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left atrial deformities

    Time frame: After 4 weeks of rehabilitation

    Left atrial deformities will be measured in %

  9. (A) other parameters of left ventricular and atrial myocardial function in the control group: Mechanical dispersion

    Time frame: Baseline

    Post-systolic contractions will be measured in mmHg%

  10. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Mechanical dispersion

    Time frame: Baseline

    Post-systolic contractions will be measured in mmHg%

  11. (A) other parameters of left ventricular and atrial myocardial function in the control group: Mechanical dispersion

    Time frame: After 4 weeks of rehabilitation

    Post-systolic contractions will be measured in mmHg%

  12. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Mechanical dispersion

    Time frame: After 4 weeks of rehabilitation

    Post-systolic contractions will be measured in mmHg%

  13. (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricle ejection fraction

    Time frame: Baseline

    Left ventricle ejection fraction will be measured in %

  14. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricle ejection fraction

    Time frame: Baseline

    Left ventricle ejection fraction will be measured in %

  15. (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricle ejection fraction

    Time frame: After 4 weeks of rehabilitation

    Left ventricle ejection fraction will be measured in %

  16. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricle ejection fraction

    Time frame: After 4 weeks of rehabilitation

    Left ventricle ejection fraction will be measured in %

  17. (A) other parameters of left ventricular and atrial myocardial function in the control group: E/E' and E/A ratio

    Time frame: Baseline

    E/E' and E/A ratio will be measured

  18. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: E/E' and E/A ratio

    Time frame: Baseline

    E/E' and E/A ratio will be measured

  19. (A) other parameters of left ventricular and atrial myocardial function in the control group: E/E' and E/A ratio

    Time frame: After 4 weeks of rehabilitation

    E/E' and E/A ratio will be measured

  20. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RTgroup: E/E' and E/A ratio

    Time frame: After 4 weeks of rehabilitation

    E/E' and E/A ratio will be measured

  21. (A) other parameters of left ventricular and atrial myocardial function in the control group: Cardiac index

    Time frame: Baseline

    Cardiac index will be measured in L/min/m2

  22. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Cardiac index

    Time frame: Baseline

    Cardiac index will be measured in L/min/m2

  23. (A) other parameters of left ventricular and atrial myocardial function in the control group: Cardiac index

    Time frame: After 4 weeks of rehabilitation

    Cardiac index will be measured in L/min/m2

  24. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Cardiac index

    Time frame: After 4 weeks of rehabilitation

    Cardiac index will be measured in L/min/m2

  25. (A) other parameters of left ventricular and atrial myocardial function in the control group: Tricuspid regurgitation flow

    Time frame: Baseline

    Tricuspid regurgitation flow will be measured in m/sec

  26. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Tricuspid regurgitation flow

    Time frame: Baseline

    Tricuspid regurgitation flow will be measured in m/sec

  27. (A) other parameters of left ventricular and atrial myocardial function in the control group: Tricuspid regurgitation flow

    Time frame: After 4 weeks of rehabilitation

    Tricuspid regurgitation flow will be measured in m/sec

  28. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Tricuspid regurgitation flow

    Time frame: After 4 weeks of rehabilitation

    Tricuspid regurgitation flow will be measured in m/sec

  29. (A) other parameters of left ventricular and atrial myocardial function in the control group: systolic pulmonary arterial pressure

    Time frame: Baseline

    Systolic pulmonary arterial pressure will be measured in mmHg

  30. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: systolic pulmonary arterial pressure

    Time frame: Baseline

    Systolic pulmonary arterial pressure will be measured in mmHg

  31. (A) other parameters of left ventricular and atrial myocardial function in the control group: systolic pulmonary arterial pressure (mmHg)

    Time frame: After 4 weeks of rehabilitation

    Systolic pulmonary arterial pressure will be measured in mmHg

  32. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: systolic pulmonary arterial pressure (mmHg)

    Time frame: After 4 weeks of rehabilitation

    Systolic pulmonary arterial pressure will be measured in mmHg

  33. (A) other parameters of left ventricular and atrial myocardial function in the control group: Vmax IT

    Time frame: Baseline

    Vmax IT will be measured in m/sec

  34. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Vmax IT

    Time frame: Baseline

    Vmax IT will be measured in m/sec

  35. (A) other parameters of left ventricular and atrial myocardial function in the control group: Vmax IT

    Time frame: After 4 weeks of rehabilitation

    Vmax IT will be measured in m/sec

  36. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Vmax IT

    Time frame: After 4 weeks of rehabilitation

    Vmax IT will be measured in m/sec

  37. (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricular volume

    Time frame: Baseline

    Left ventricular telesystolic and telediastolic volumes will be measured

  38. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricular volume

    Time frame: Baseline

    Left ventricular telesystolic and telediastolic volumes will be measured

  39. (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricular volume

    Time frame: After 4 weeks of rehabilitation

    Left ventricular telesystolic and telediastolic volumes will be measured

  40. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricular volume

    Time frame: After 4 weeks of rehabilitation

    Left ventricular telesystolic and telediastolic volumes will be measured

  41. (A) other parameters of left ventricular and atrial myocardial function in the control group: Atrial volume

    Time frame: Baseline

    Atrial telesystolic and telediastolic volumes will be measured

  42. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Atrial volume

    Time frame: Baseline

    Atrial telesystolic and telediastolic volumes will be measured

  43. (A) other parameters of left ventricular and atrial myocardial function in the control group: Atrial volume

    Time frame: After 4 weeks of rehabilitation

    Atrial telesystolic and telediastolic volumes will be measured

  44. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Atrial volume

    Time frame: After 4 weeks of rehabilitation

    Atrial telesystolic and telediastolic volumes will be measured

  45. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Myocardial work

    Time frame: Baseline

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

  46. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Myocardial work

    Time frame: Baseline

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

  47. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Myocardial work

    Time frame: After 4 weeks of rehabilitation

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

  48. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Myocardial work

    Time frame: After 4 weeks of rehabilitation

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

  49. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left atrial deformities

    Time frame: Baseline

    Left atrial deformities will be measured in %

  50. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left atrial deformities

    Time frame: Baseline

    Left atrial deformities will be measured in %

  51. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left atrial deformities

    Time frame: After 4 weeks of rehabilitation

    Left atrial deformities will be measured in %

  52. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left atrial deformities

    Time frame: After 4 weeks of rehabilitation

    Left atrial deformities will be measured in %

  53. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Mechanical dispersion

    Time frame: Baseline

    Post-systolic contractions will be measured in mmHg%

  54. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Mechanical dispersion

    Time frame: Baseline

    Post-systolic contractions will be measured in mmHg%

  55. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Mechanical dispersion

    Time frame: After 4 weeks of rehabilitation

    Post-systolic contractions will be measured in mmHg%

  56. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Mechanical dispersion

    Time frame: After 4 weeks of rehabilitation

    Post-systolic contractions will be measured in mmHg%

  57. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left ventricle ejection fraction

    Time frame: Baseline

    The left ventricle ejection fraction will be measured as a percentage

  58. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left ventricle ejection fraction

    Time frame: Baseline

    The left ventricle ejection fraction will be measured as a percentage

  59. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left ventricle ejection fraction

    Time frame: After 4 weeks of rehabilitation

    The left ventricle ejection fraction will be measured as a percentage

  60. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left ventricle ejection fraction

    Time frame: After 4 weeks of rehabilitation

    The left ventricle ejection fraction will be measured as a percentage

  61. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: E/E' and E/A ratio

    Time frame: Baseline

    The E/E' and E/A ratio will be measured

  62. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: E/E' and E/A ratio

    Time frame: Baseline

    The E/E' and E/A ratio will be measured

  63. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: E/E' and E/A ratio

    Time frame: After 4 weeks of rehabilitation

    The E/E' and E/A ratio will be measured

  64. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: E/E' and E/A ratio

    Time frame: After 4 weeks of rehabilitation

    The E/E' and E/A ratio will be measured

  65. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: cardiac index

    Time frame: Baseline

    Cardiac index will be measured in L/min/m2

  66. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: cardiac index

    Time frame: Baseline

    Cardiac index will be measured in L/min/m2

  67. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: cardiac index

    Time frame: After 4 weeks of rehabilitation

    Cardiac index will be measured in L/min/m2

  68. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: cardiac index

    Time frame: After 4 weeks of rehabilitation

    Cardiac index will be measured in L/min/m2

  69. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Tricuspid regurgitation flow

    Time frame: Baseline

    Tricuspid regurgitation flow will be measured in m/sec

  70. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Tricuspid regurgitation flow

    Time frame: Baseline

    Tricuspid regurgitation flow will be measured in m/sec

  71. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Tricuspid regurgitation flow

    Time frame: After 4 weeks of rehabilitation

    Tricuspid regurgitation flow will be measured in m/sec

  72. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Tricuspid regurgitation flow

    Time frame: After 4 weeks of rehabilitation

    Tricuspid regurgitation flow will be measured in m/sec

  73. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: systolic pulmonary arterial pressure

    Time frame: Baseline

    Systolic pulmonary arterial pressure will be measured in mmHg

  74. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: systolic pulmonary arterial pressure

    Time frame: Baseline

    Systolic pulmonary arterial pressure will be measured in mmHg

  75. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: systolic pulmonary arterial pressure

    Time frame: After 4 weeks of rehabilitation

    Systolic pulmonary arterial pressure will be measured in mmHg

  76. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: systolic pulmonary arterial pressure

    Time frame: After 4 weeks of rehabilitation

    Systolic pulmonary arterial pressure will be measured in mmHg

  77. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Vmax IT

    Time frame: Baseline

    Vmax IT will be measured in m/sec

  78. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Vmax IT

    Time frame: Baseline

    Vmax IT will be measured in m/sec

  79. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Vmax IT

    Time frame: After 4 weeks of rehabilitation

    Vmax IT will be measured in m/sec

  80. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Vmax IT

    Time frame: After 4 weeks of rehabilitation

    Vmax IT will be measured in m/sec

  81. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Atrial volume

    Time frame: Baseline

    Atrial telesystolic and telediastolic volumes will be measured

  82. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Atrial volume

    Time frame: Baseline

    Atrial telesystolic and telediastolic volumes will be measured

  83. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Atrial volume

    Time frame: After 4 weeks of rehabilitation

    Atrial telesystolic and telediastolic volumes will be measured

  84. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Atrial volume

    Time frame: After 4 weeks of rehabilitation

    Atrial telesystolic and telediastolic volumes will be measured

  85. (C) Stress test measurement in controls : peak oxygen consumption

    Time frame: Baseline

    Peak oxygen consumption (VO2pic) will be measured in mL/min/kg

  86. (C) Stress test measurement in the BFR+RT group : peak oxygen consumption

    Time frame: Baseline

    Peak oxygen consumption (VO2pic) will be measured in mL/min/kg

  87. (C) Stress test measurement in controls : peak oxygen consumption

    Time frame: After 4 weeks of rehabilitation

    Peak oxygen consumption (VO2pic) will be measured in mL/min/kg

  88. (C) Stress test measurement in the BFR+RT group: peak oxygen consumption

    Time frame: After 4 weeks of rehabilitation

    Peak oxygen consumption (VO2pic) will be measured in mL/min/kg

  89. (C) Stress test measurement in controls : Maximum aerobic power

    Time frame: Baseline

    Maximum aerobic power will be measured in Watts

    • First ventilatory threshold (SV1) mL/min/kg

  90. (C) Stress test measurement in the BFR+RT group : Maximum aerobic power

    Time frame: Baseline

    Maximum aerobic power will be measured in Watts

    • First ventilatory threshold (SV1) mL/min/kg

  91. (C) Stress test measurement in controls : Maximum aerobic power

    Time frame: After 4 weeks of rehabilitation

    Maximum aerobic power will be measured in Watts

    • First ventilatory threshold (SV1) mL/min/kg

  92. (C) Stress test measurement in the BFR+RT group : Maximum aerobic power

    Time frame: After 4 weeks of rehabilitation

    Maximum aerobic power will be measured in Watts

    • First ventilatory threshold (SV1) mL/min/kg

  93. (C) Stress test measurement in controls : First ventilatory threshold

    Time frame: Baseline

    First ventilatory threshold will be measured in mL/min/kg

  94. (C) Stress test measurement in the BFR+RT group : First ventilatory threshold

    Time frame: Baseline

    First ventilatory threshold will be measured in mL/min/kg

  95. (C) Stress test measurement in controls : First ventilatory threshold

    Time frame: After 4 weeks of rehabilitation

    First ventilatory threshold will be measured in mL/min/kg

  96. (C) Stress test measurement in the BFR+RT group : First ventilatory threshold

    Time frame: After 4 weeks of rehabilitation

    First ventilatory threshold will be measured in mL/min/kg

  97. (C) Muscular evaluation in controls: Peak torque

    Time frame: Baseline

    Peak torque will be measured in Nm

  98. (C) Muscular evaluation in the BFR+RT group: Peak torque

    Time frame: Baseline

    Peak torque will be measured in Nm

  99. (C) Muscular evaluation in controls: Peak torque

    Time frame: After 4 weeks of rehabilitation

    Peak torque will be measured in Nm

  100. (C) Muscular evaluation in the BFR+RT group: Peak torque

    Time frame: After 4 weeks of rehabilitation

    Peak torque will be measured in Nm

  101. (C) Muscular evaluation in controls: Maximum repetition

    Time frame: Baseline

    Maximum repetition will be measured in kilograms

  102. (C) Muscular evaluation in the BFR+RT group: Maximum repetition

    Time frame: Baseline

    Maximum repetition will be measured in kilograms

  103. (C) Muscular evaluation in controls: Maximum repetition

    Time frame: After 4 weeks of rehabilitation

    Maximum repetition will be measured in kilograms

  104. (C) Muscular evaluation in the BFR+RT group: Maximum repetition

    Time frame: After 4 weeks of rehabilitation

    Maximum repetition will be measured in kilograms

  105. (D) Clinical and biological measurement in controls: Body mass index

    Time frame: Baseline

    Body mass index will be measured in Kg/m2

  106. (D) Clinical and biological measurement in the BFR+RT group: Body mass index

    Time frame: Baseline

    Body mass index will be measured in Kg/m2

  107. (D) Clinical and biological measurement in controls: Body mass index

    Time frame: After 4 weeks of rehabilitation

    Body mass index will be measured in Kg/m2

  108. (D) Clinical and biological measurement in the BFR+RT group: Body mass index

    Time frame: After 4 weeks of rehabilitation

    Body mass index will be measured in Kg/m2

  109. (D) Clinical and biological measurement in controls: Waist circumference

    Time frame: Baseline

    Waist circumference will be measured in cm

  110. (D) Clinical and biological measurement in the BFR+RT group: Waist circumference

    Time frame: Baseline

    Waist circumference will be measured in cm

  111. (D) Clinical and biological measurement in controls: Waist circumference

    Time frame: After 4 weeks of rehabilitation

    Waist circumference will be measured in cm

  112. (D) Clinical and biological measurement in the BFR+RT group: Waist circumference

    Time frame: After 4 weeks of rehabilitation

    Waist circumference will be measured in cm

  113. (D) Clinical and biological measurement in controls: Lipid profile

    Time frame: Baseline

    Lipids will be measured in mmol/L

  114. (D) Clinical and biological measurement in the BFR+RT group: Lipid profile

    Time frame: Baseline

    Lipids will be measured in mmol/L

  115. (D) Clinical and biological measurement in controls: Lipid profile

    Time frame: After 4 weeks of rehabilitation

    Lipids will be measured in mmol/L

  116. (D) Clinical and biological measurement in the BFR+RT group: Lipid profile

    Time frame: After 4 weeks of rehabilitation

    Lipids will be measured in mmol/L

  117. (D) Clinical and biological measurement in controls: Glycated hemoglobin

    Time frame: Baseline

    Glycated hemoglobin will be measured as a %

  118. (D) Clinical and biological measurement in the BFR+RT group: Glycated hemoglobin

    Time frame: Baseline

    Glycated hemoglobin will be measured as a %

  119. (D) Clinical and biological measurement in controls: Glycated hemoglobin

    Time frame: After 4 weeks of rehabilitation

    Glycated hemoglobin will be measured as a %

  120. (D) Clinical and biological measurement in the BFR+RT group: Glycated hemoglobin

    Time frame: After 4 weeks of rehabilitation

    Glycated hemoglobin will be measured as a %

  121. (D) Clinical and biological measurement in controls: Fasting blood glucose

    Time frame: Baseline

    Fasting blood glucose will be measured in g/L

  122. (D) Clinical and biological measurement in the BFR+RT group: Fasting blood glucose

    Time frame: Baseline

    Fasting blood glucose will be measured in g/L

  123. (D) Clinical and biological measurement in controls: Fasting blood glucose

    Time frame: After 4 weeks of rehabilitation

    Fasting blood glucose will be measured in g/L

  124. (D) Clinical and biological measurement in the BFR+RT group: Fasting blood glucose

    Time frame: After 4 weeks of rehabilitation

    Fasting blood glucose will be measured in g/L

  125. (D) Clinical and biological measurement in controls: Pro-Brain Natriuretic Peptide

    Time frame: Baseline

    Pro-Brain Natriuretic Peptide will be measured in ng/L

  126. (D) Clinical and biological measurement in the BFR+RT group: Pro-Brain Natriuretic Peptide

    Time frame: Baseline

    Pro-Brain Natriuretic Peptide will be measured in ng/L

  127. (D) Clinical and biological measurement in controls: Pro-Brain Natriuretic Peptide

    Time frame: After 4 weeks of rehabilitation

    Pro-Brain Natriuretic Peptide will be measured in ng/L

  128. (D) Clinical and biological measurement in the BFR+RT group: Pro-Brain Natriuretic Peptide

    Time frame: After 4 weeks of rehabilitation

    Pro-Brain Natriuretic Peptide will be measured in ng/L

  129. (D) Clinical and biological measurement in controls: C-reactive protein

    Time frame: Baseline

    C-reactive protein will be measured in mg/L

  130. (D) Clinical and biological measurement in the BFR+RT group: C-reactive protein

    Time frame: Baseline

    C-reactive protein will be measured in mg/L

  131. (D) Clinical and biological measurement in controls: C-reactive protein

    Time frame: After 4 weeks of rehabilitation

    C-reactive protein will be measured in mg/L

  132. (D) Clinical and biological measurement in the BFR+RT group: C-reactive protein

    Time frame: After 4 weeks of rehabilitation

    C-reactive protein will be measured in mg/L

  133. (D) Clinical and biological measurement in controls: Micro ribonucleic acids

    Time frame: Baseline

    Micro ribonucleic acids will be measured in ng/µl

  134. (D) Clinical and biological measurement in the BFR+RT group: Micro ribonucleic acids

    Time frame: Baseline

    Micro ribonucleic acids will be measured in ng/µl

  135. (D) Clinical and biological measurement in controls: Micro ribonucleic acid

    Time frame: After 4 weeks of rehabilitation

    Micro ribonucleic acids will be measured in ng/µl

  136. (D) Clinical and biological measurement in the BFR+RT group: Micro ribonucleic acid

    Time frame: After 4 weeks of rehabilitation

    Micro ribonucleic acids will be measured in ng/µl

  137. (E) MacNew Heart Disease Quality of Life score in controls

    Time frame: Baseline

    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

  138. (E) MacNew Heart Disease Quality of Life score in the BFR+RT group

    Time frame: Baseline

    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

  139. (E) MacNew Heart Disease Quality of Life score in controls

    Time frame: After 4 weeks of rehabilitation

    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

  140. (E) MacNew Heart Disease Quality of Life score in the BFR+RT group

    Time frame: After 4 weeks of rehabilitation

    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

  141. (F) International Physical Activity Questionnaire in controls

    Time frame: Baseline

    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.

  142. (F) International Physical Activity Questionnaire in the BFR+RT group

    Time frame: Baseline

    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.

  143. (F) International Physical Activity Questionnaire in controls

    Time frame: After 4 weeks of rehabilitation

    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.

  144. (F) International Physical Activity Questionnaire in the BFR+RT group

    Time frame: After 4 weeks of rehabilitation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anissa MEGZARI

CONTACT

[email protected]

0466684236

Clarisse BELVISI

CONTACT

[email protected]

+33466683459

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Effect of Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction

Acronym: ERFOCARD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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