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临床试验/NCT05446103
NCT05446103Unknown不适用

The Acute Effect of Upper Limb Low Load Blood Flow Restriction Training (BFRT) on Hypoalgesia. A Randomized Controlled Trial

University of West Attica2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefanos Karanasios

Principal Investigator

University of West Attica

研究点 (2)

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