Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction
NCT07118410 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2025-08-12
Summary
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.
Conditions
- Heart Failure
- Ventricular Function, Left
Interventions
- DEVICE
-
Application of a vascular restriction device during resistance training
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.
Sponsors & Collaborators
-
Centre Hospitalier Universitaire de Nīmes
lead OTHER
Principal Investigators
-
Christelle ROBERT, Dr. · Nîmes University Hospital
-
Alice GAUTHIER, Dr. · Nîmes University Hospital
-
Clara GROMOFF, Dr. · Nîmes University Hospital
-
Bertrand LEDERMANN, Dr. · Nîmes University Hospital
-
Philippe OBERT, Dr. · UFR Sciences Technologies Centre INRAE, Avignon
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-01
- Primary Completion
- 2027-08-01
- Completion
- 2027-09-01
Countries
- France
Study Locations
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