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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• RT control group [Срок оценки: Baseline]
• BFR+RT group [Срок оценки: Baseline]
• RT control group [Срок оценки: After 4 weeks of rehabilitation]
• BFR+RT group [Срок оценки: After 4 weeks of rehabilitation]

Вторичные конечные точки (12)

• (A) other parameters of left ventricular and atrial myocardial function in the control group: Myocardial work [Срок оценки: Baseline]
• (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Myocardial work [Срок оценки: Baseline]
• (A) other parameters of left ventricular and atrial myocardial function in the control group: Myocardial work [Срок оценки: After 4 weeks of rehabilitation]
• (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Myocardial work [Срок оценки: After 4 weeks of rehabilitation]
• (A) other parameters of left ventricular and atrial myocardial function in the control group: Left atrial deformities [Срок оценки: Baseline]
• (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left atrial deformities [Срок оценки: Baseline]
• (A) other parameters of left ventricular and atrial myocardial function in the control group: Left atrial deformities [Срок оценки: After 4 weeks of rehabilitation]
• (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left atrial deformities [Срок оценки: After 4 weeks of rehabilitation]
• (A) other parameters of left ventricular and atrial myocardial function in the control group: Mechanical dispersion [Срок оценки: Baseline]
• (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Mechanical dispersion [Срок оценки: Baseline]
• (A) other parameters of left ventricular and atrial myocardial function in the control group: Mechanical dispersion [Срок оценки: After 4 weeks of rehabilitation]
• (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Mechanical dispersion [Срок оценки: After 4 weeks of rehabilitation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Nîmes University Hospital — Nîmes

Публикации

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• Billah M, Ridiandries A, Allahwala U, Mudaliar H, Dona A, Hunyor S, Khachigian LM, Bhindi R. Circulating mediators of remote ischemic preconditioning: search for the missing link between non-lethal ischemia and cardioprotection. Oncotarget. 2019 Jan 4;10(2):216-244. doi: 10.18632/oncotarget.26537. eCollection 2019 Jan 4. PMID 30719216
• Birnbaum Y, Hale SL, Kloner RA. Ischemic preconditioning at a distance: reduction of myocardial infarct size by partial reduction of blood supply combined with rapid stimulation of the gastrocnemius muscle in the rabbit. Circulation. 1997 Sep 2;96(5):1641-6. doi: 10.1161/01.cir.96.5.1641. PMID 9315559
• Botker HE, Lassen TR, Jespersen NR. Clinical translation of myocardial conditioning. Am J Physiol Heart Circ Physiol. 2018 Jun 1;314(6):H1225-H1252. doi: 10.1152/ajpheart.00027.2018. Epub 2018 Mar 2. PMID 29498531
• Cahalin LP, Formiga MF, Owens J, Anderson B, Hughes L. Beneficial Role of Blood Flow Restriction Exercise in Heart Disease and Heart Failure Using the Muscle Hypothesis of Chronic Heart Failure and a Growing Literature. Front Physiol. 2022 Jul 6;13:924557. doi: 10.3389/fphys.2022.924557. eCollection 2022. PMID 35874535

Идентификаторы

NCT: NCT07118410 · NIMAO/2024-2/CB-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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