The Acute Effect of Upper Limb Low Load Blood Flow Restriction Training (BFRT) on Hypoalgesia. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pressure pain threshold
研究概览
简要总结
A randomized controlled trial comparing the immediate effects of upper limb low-load blood flow restriction training (BFRT) with high load sham-BFRT on hypoalgesia and perceptual response in healthy adults
详细描述
Healthy individuals will be randomized to one of two groups. A target of 40 patients for enrollment has been set for 80% power, p<0.05 (Effect size= 1). A single Intervention will be used (40 minutes).
Intervention Group: A single exercise of elbow flexion with Blood Flow Restriction (30-15-15-15 reps) using 30% of 1 Repetition Maximum.
Control Group: A single exercise of elbow flexion with sham Blood Flow Restriction (4x10 reps) using 65% of 1 Repetition Maximum.
Primary outcome: pressure pain thresholds on quadriceps, biceps, lateral epicondyle and upper trapezius (bilateral).
Secondary outcomes: difference in perceptual response (exertion), change in blood pressure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Using sham blood flow restriction (A cuff will be placed on the arm with minimum pressure <20% of arterial occlusive pressure)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able to perform full elbow flexion and extension
排除标准
- •shoulder tendinopathy,
- •cervical radiculopathy,
- •rheumatoid arthritis,
- •neurological deficit,
- •serious cardiovascular diseases,
- •venous deficiency,
- •history of heart surgery,
- •cancer history,
- •breast surgery,
- •orthopaedic surgeries during the last 6 months,
- •thrombosis,
- •diabetes,
- •body mass Index ≥ 30,
- •Crohn syndrome,
- •family or personal history of pulmonary embolism
研究组 & 干预措施
BFR
20 healthy individuals will be assigned to perform elbow flexion exercises with low-load resistance BFR training (30% of 1 RM)
干预措施: Blood flow restriction training (Other)
Sham BFR
20 healthy individuals will be assigned to perform elbow flexion exercises with high-load resistance training with sham BFR (65% of 1 RM)
干预措施: Sham Blood flow restriction training (Other)
结局指标
主要结局
Pressure pain threshold
时间窗: Baseline and 30 minutes
Changes between pre- and post- intervention in Pressure Pain Threshold will be measured using bilateral sites on quadriceps, upper trapezius, lateral epicondyle and biceps. The COMPACT DIGITAL ALGOMETER CAPACITIES TO: 100 lbf / 50 kgf / 500 N, will be used by an independent assessor. The assessor will be blinded to participants' group.
次要结局
- Rating of perceived exertion(At the end of the 1st, 2nd, 3rd and 4th set ( after 1, 2, 3 and 4 minutes respectively))
- Blood pressure(Baseline and 30 minutes)
研究者
Stefanos Karanasios
Principal Investigator
University of West Attica