Application of Blood Flow Restriction Training in Cardiac Patients: CARDresfluj Study

University of Valencia

Status: Not yet enrolling

Conditions: Cardiac Rehabilitation

Treatments: Other: Traditional Cardiac Rehabilitation, phase III; Other: Blood Flow Restriction Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07361393

2024-FIS-3751550

Details and patient eligibility

About

1. Research Objective

   To describe and compare the effects on cardiovascular health, physical fitness, quality of life, oxidative stress, and sleep quality resulting from a conventional resistance training program versus a conventional resistance training program partially implemented with Blood Flow Restriction (BFR) in patients with Phase III cardiac disease.

2. Methodology, Expected Collaboration, and Duration

Participants will be invited to undergo assessments for physical fitness, functional capacity, cardiological, hemodynamic, and biochemical control, as well as perceived quality of life and sleep quality, both prior to and following the intervention.

Your collaboration in this study will consist of participating in a Phase III Cardiac Rehabilitation program, monitored by specialized personnel and supervised by a cardiologist.

The intervention is based on a resistance training program supplemented with leg press and biceps curl exercises. These specific exercises will be performed using a blood flow restriction cuff.

The intervention will be conducted twice weekly over a 10-week period, followed by a 2-months washout (rest) period. Subsequently, the 10-week intervention will be repeated; however, if the first phase was completed with the use of cuffs, the second phase will be conducted without them, and vice-versa (cross-over design).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All participants must be of legal age (≥18 years) and provide signed informed consent prior to any study procedures
• Participants must have a confirmed medical diagnosis of stable cardiac disease (e.g., post-myocardial infarction, stable angina, or post-revascularization) as documented by a specialist.
• All subjects must be currently enrolled in or actively participating in a Phase III Cardiac Rehabilitation program (the maintenance phase).
• Evidence of clinical stability is required, ensuring that participants can safely perform resistance training without immediate cardiovascular contraindications.

Exclusion criteria

• Unstable Cardiovascular Status: Presence of unstable angina, uncontrolled cardiac arrhythmias, or severe symptomatic aortic stenosis.
• Recent Acute Events: Myocardial infarction, coronary artery bypass graft (CABG), or other major cardiac surgeries within the last 3 months (or outside the timeframe defined for Phase III eligibility).
• Uncontrolled Hypertension: Resting systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg despite pharmacological treatment.
• Specific Contraindications to BFR: History of deep vein thrombosis (DVT), peripheral vascular disease, or severe lymphedema in the limbs designated for cuff application.
• Musculoskeletal Limitations: Any orthopedic or neuromuscular condition that prevents the safe performance of biceps curls or leg press exercises.
• Concurrent High-Intensity Training: Participation in any other structured vigorous-intensity exercise program that could confound the results of the intervention.
• Medical Instability: Significant comorbid conditions, such as uncontrolled metabolic disease (e.g., Type 2 Diabetes with severe complications), advanced renal failure, or respiratory diseases that limit functional capacity below the study requirements.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Blood Flow Restriction

Experimental group

Description:

A pneumatic compression cuff, calibrated to 40% of the total arterial occlusion pressure-preliminarily determined via Doppler ultrasound-will be positioned at the axillary region for the performance of biceps curls and at the inguinal region for the leg press. The training protocol will follow the established consensus of one set of 30 repetitions followed by three sets of 15 repetitions, with 60-second inter-set rest intervals during which the cuff will be deflated to allow for reperfusion

Treatment:

Other: Blood Flow Restriction Exercise

Traditional Cardiac Rehabilitation, phase III

Active Comparator group

Description:

The control group will undergo the identical intervention protocol, but without the application of blood flow restriction

Treatment:

Other: Traditional Cardiac Rehabilitation, phase III