Application of Blood Flow Restriction Training in Cardiac Patients: CARDresfluj Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Indirect 1 repetition maximum
研究概览
简要总结
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Traditional Cardiac Rehabilitation, phase III
The control group will undergo the identical intervention protocol, but without the application of blood flow restriction
干预措施: Traditional Cardiac Rehabilitation, phase III (Other)
Blood Flow Restriction
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
干预措施: Blood Flow Restriction Exercise (Other)
结局指标
主要结局
Indirect 1 repetition maximum
时间窗: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases
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.
Heart Rate Variability
时间窗: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases
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).
Tendon Thickness
时间窗: Pre intervention (week 0) and post intervention (week 11) in experimental and control phases
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.
次要结局
- 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)
- 6 min walking(Pre intervention (week 0) and post intervention (week 11) in experimental and control phases)
- SF-36(Pre intervention (week 0) and post intervention (week 11) in experimental and control phases)
研究者
Ivan Chulvi Medrano
Associate Professor of Physical Education and Sport
University of Valencia