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

NCT07118410 | Not Yet Recruiting

• 1 other identifier: NIMAO/2024-2/CB-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiac rehabilitation; Resistance training; Blood flow restriction; Cardiac function; Speckle tracking echography; Heart failure with reduced ejection fraction

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (144)

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

  Baseline

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

  Baseline

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

  After 4 weeks of rehabilitation

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

  After 4 weeks of rehabilitation

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

  Baseline

Study Arms (2)

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.

Device: Application of a vascular restriction device during resistance training

Interventions

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.

Also known as: Resistance training

RT+BFR group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient participating in another Category I interventional study, or having participated in another interventional study in the last month
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nîmes University Hospital

Nîmes, Gard, 30029, France

Location

Related Publications (30)

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MeSH Terms

Conditions

Heart Failure

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christelle ROBERT, Dr.

  Nîmes University Hospital

  STUDY DIRECTOR

• Alice GAUTHIER, Dr.

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

• Clara GROMOFF, Dr.

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

• Bertrand LEDERMANN, Dr.

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

• Philippe OBERT, Dr.

  UFR Sciences Technologies Centre INRAE, Avignon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clarisse BELVISI

CONTACT

+33466683459; clarisse.belvisi@chu-nimes.fr

Anissa MEGZARI

CONTACT

0466684236; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary endpoint assessor is blinded to the group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 12, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-07

Locations

FR (1)