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

NCT07361393 | Active Not Recruiting

• 1 other identifier: 2024-FIS-3751550
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Research Objective
2. 2.Methodology, Expected Collaboration, and Duration

Conditions

Cardiac Rehabilitation

Keywords

blood flow restriction

Outcome Measures

Primary Outcomes (3)

• Indirect 1 repetition maximum

  The Brzycki formula is a widely recognized equation used to predict a participant's maximum strength based on submaximal performance. Similar to the Epley method, it is highly valued in clinical settings-such as Phase III Cardiac Rehabilitation-because it avoids the excessive cardiovascular strain and the Valsalva maneuver associated with maximal (1RM) testing. Procedure and ProtocolSubmaximal Loading: A load is selected that the participant can lift for a range of 2 to 10 repetitions. Research suggests that the Brzycki formula maintains higher accuracy when the number of repetitions is kept below 10. 1Execution to Volitional Fatigue: The participant performs the exercise (e.g., leg press or biceps curl) with controlled technique until they reach a point where no further complete repetitions can be performed. Calculation: The achieved repetitions and the weight used are integrated into the formula to determine the theoretical 1RM.

  Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

• Heart Rate Variability

  Heart Rate Variability (HRV) will be monitored to evaluate the balance between sympathetic and parasympathetic nervous system activity. The Polar H10 heart rate monitor-a chest-strap based sensor-will be utilized to capture R-R intervals (the time between successive heartbeats) with high temporal resolution. Data Acquisition Protocol Preparation: To ensure optimal conductivity and signal quality, the electrode areas of the Polar H10 strap will be moistened with water or conductive gel before being secured firmly around the participant's chest, just below the pectoral muscles. Stabilization Period: Participants will remain in a seated position for a 15-minute stabilization period to achieve a resting physiological state and minimize external artifacts. Recording: R-R interval data will be recorded for a duration of whole session and 15 minutes post-session Signal Processing: The raw data will be filtered using a compatible software interface (e.g., Kubios HRV).

  Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

• Tendon Thickness

  To evaluate structural adaptations following the intervention, the tendon thickness of the biceps brachii and the quadriceps femoris (specifically the patellar tendon) was measured using high-resolution B-mode ultrasonography. This non-invasive imaging technique allows for the precise quantification of connective tissue morphology. Measurement ProtocolBiceps Brachii Tendon: Measurements were taken with the participant in a supine position, with the arm fully extended and supinated. The transducer was placed longitudinally over the bicipital groove of the humerus to identify the long head of the biceps tendon. Quadriceps Femoris (Patellar Tendon): The participant was placed in a supine position with the knee flexed at 30% to maintain tendon tension and eliminate slack. The measurement was localized at proximal region of the patella. Data Acquisition: Images were captured in the longitudinal and transversal plane.

  Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

Secondary Outcomes (7)

• CSA grossor

  Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

• Blood Pressure

  Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

• Handgrip test

  Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

• Timed-uo and Go

  Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

• 30 seconds sit to stand

  Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

Other Outcomes (2)

• Assessment of Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)

  Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

• IPAC

  Pre intervention (week 0) and post intervention (week 11) in experimental and control phases

Study Arms (2)

Blood Flow Restriction

EXPERIMENTAL

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

Other: Blood Flow Restriction Exercise

Traditional Cardiac Rehabilitation, phase III

ACTIVE COMPARATOR

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

Other: Traditional Cardiac Rehabilitation, phase III

Interventions

Blood Flow Restriction Exercise OTHER

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

Also known as: Occlusive training

Blood Flow Restriction

Traditional Cardiac Rehabilitation, phase III OTHER

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

Also known as: Cardiovascular Rehabilitation

Traditional Cardiac Rehabilitation, phase III

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Poliesportiu Municipal

Ontinyent, Valencia, 46870, Spain

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy; Clinical Trials, Phase III as Topic; Cardiac Rehabilitation

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Education and Sport

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

ES (1)