Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction
NCT ID: NCT07118410
Last Updated: 2025-08-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
38 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-08-01
Study Completion Date
2027-09-01
Brief Summary
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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.
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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Detailed Description
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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.
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.
Conditions
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Heart Failure
Ventricular Function, Left
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
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.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Outcome Assessors
The primary endpoint assessor is blinded to the group
Study Groups
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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
Group Type
NO_INTERVENTION
No interventions assigned to this group
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.
Group Type
EXPERIMENTAL
Application of a vascular restriction device during resistance training
Intervention Type
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.
Interventions
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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.
Intervention Type
DEVICE
Other Intervention Names
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Resistance training
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Christelle ROBERT, Dr.
Role: STUDY_DIRECTOR
Nîmes University Hospital
Alice GAUTHIER, Dr.
Role: PRINCIPAL_INVESTIGATOR
Nîmes University Hospital
Clara GROMOFF, Dr.
Role: PRINCIPAL_INVESTIGATOR
Nîmes University Hospital
Bertrand LEDERMANN, Dr.
Role: PRINCIPAL_INVESTIGATOR
Nîmes University Hospital
Philippe OBERT, Dr.
Role: PRINCIPAL_INVESTIGATOR
UFR Sciences Technologies Centre INRAE, Avignon
Locations
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Nîmes University Hospital
Nîmes, Gard, France
Site Status
Countries
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France
Central Contacts
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References
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Other Identifiers
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NIMAO/2024-2/CB-01
Identifier Type: -
Identifier Source: org_study_id
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