Acute Responses to Different Blood Flow Restriction Exercise Configurations With Dynamic Pressure Compared to Fixed Pressure in Patients With Severe Gonarthrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pain intensity at rest (Visual Analogue Scale, 0-10)
研究概览
简要总结
This study aims to evaluate the acute effects of blood flow restriction (BFR) training on hypoalgesia and neuromuscular responses in patients with severe gonarthrosis by comparing the application of pressure with a dynamic versus a fixed configuration. There will be six different training conditions with varying levels of blood flow occlusion (%BFR) and percentage of load (%RM): 1) 30% RM and 50% BFR with dynamic pressure; 2) 30% RM and 50% BFR with fixed pressure; 3) 50% RM and 50% BFR with dynamic pressure; 4) 50% RM and 50% BFR with fixed pressure; 5) 30% RM and 80% BFR with dynamic pressure; 6) 30% RM and 80% BFR with fixed pressure.
Each participant will complete six individual sessions under different training conditions, assigned in a random order with a 72-hour interval between each session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 and 85 years
- •Diagnosis of severe gonarthrosis according to the clinical and radiographic criteria of the American College of Rheumatology guidelines.
- •On the waiting list for unilateral total knee replacement (TKR) surgery
排除标准
- •Pain in the contralateral leg with an intensity ≥80/100 mm on the visual analog scale (VAS) during daily activities.
- •Previous hip or knee replacement surgery and osteotomy within the last year.
- •Autoimmune arthritis
- •Medical conditions that contraindicate exercise.
- •Participation in exercise programs (>2 days/week with training at intensities of 10-15 1RM) in the previous six months.
- •History of stroke, brain surgery, major depression, or self-reported cognitive impairment that could affect performance in the study.
- •Cardiovascular, thrombotic, or vascular risk factors (uncontrolled hypertension, peripheral arterial disease, history of deep vein thrombosis or pulmonary embolism, heart failure, severe varicose veins, or uncontrolled anticoagulant therapy).
- •Skin or local alterations at the cuff application site (ulcers, open wounds, infections, lymphedema, or severe edema).
- •Inability to communicate normally or with impaired communication skills.
研究组 & 干预措施
Low-load resistance exercise with moderate blood occlusion and dynamic pressure.
A single session of exercise, 30% repetition maximum, 50% blood occlusion, and dynamic pressure
干预措施: Moderate-intensity resistance exercise with low arterial occlusion pressure and dynamic pressure. (Device)
Low-load resistance exercise with moderate blood occlusion and fixed pressure.
A single session of exercise, 30% repetition maximum, 50% blood occlusion, and fixed pressure
干预措施: Moderate-intensity resistance exercise with low arterial occlusion pressure and fixed pressure. (Device)
Moderate-load resistance exercise with low blood occlusion and dynamic pressure.
A single session of exercise, 50% repetition maximum, 30% blood occlusion, and dynamic pressure
干预措施: Low-intensity resistance exercise with high arterial occlusion pressure and dynamic pressure. (Device)
Moderate-load resistance exercise with low blood occlusion and fixed pressure.
A single session of exercise, 50% repetition maximum, 30% blood occlusion, and fixed pressure
干预措施: Low-intensity resistance exercise with high arterial occlusion pressure and fixed pressure. (Device)
Low-load resistance exercise with high blood occlusion and dynamic pressure
A single session of exercise, 15% repetition maximum, 80% blood occlusion, and dynamic pressure
干预措施: Low-intensity resistance exercise with moderate arterial occlusion pressure and dynamic pressure. (Device)
Low-load resistance exercise with high blood occlusion and fixed pressure
A single session of exercise, 15% repetition maximum, 80% blood occlusion, and fixed pressure
干预措施: Low-intensity resistance exercise with moderate arterial occlusion pressure and fixed pressure. (Device)
结局指标
主要结局
Pain intensity at rest (Visual Analogue Scale, 0-10)
时间窗: Periprocedural
Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.
次要结局
- Pressure pain threshold(Periprocedural)
- Perceived exertion scale (The BORG CR10 Scale)(Periprocedural)
- Functional Measure (Western Ontario and McMaster Universities Osteoarthritis Index)(Baseline)
- Surface electromyography(Periprocedural)
- Occurrence of adverse effects(Immediately after the intervention, 72 hours later, and two weeks after the study ended.)
- Pain catastrophizing(Baseline)
- Kinesiophobia (The Tampa Scale for Kinesiophobia)(Baseline)
研究者
Adrián Escriche Escuder
Assistant professor
University of Valencia