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临床试验/DRKS00033583
DRKS00033583招募中Unknown

A sham-treatment-controlled, randomized single-blinded study on the influence of 6 weeks of prehabilitation training under local muscular hypoxia (Blood Flow Restriction Training) prior to arthroscopic anterior cruciate ligament replacement on knee joint function, morphology and strength. - BFR-Prehab

BG Klinikum Duisburg gGmbH0 个研究点目标入组 40 人开始时间: 2024年3月19日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 40 Years(—)
性别
All

入选标准

  • BMI: male 20-30, female 19-30
  • - Tegner score 4-9
  • Irritation-free knee joint:
  • - Pain: VAS [1-10]: < 3
  • - Swelling: circumference [cm] < 3 (5cm < center of patella > 5cm)
  • - Heat: temperature [°] < 2
  • - Function: 10 squats without additional load
  • - Unilateral ACL rupture including concomitant injuries requiring treatment (e.g. partial meniscus resection), from which no changed follow-up treatment is derived

排除标准

  • Cardiovascular diseases:
  • - Coronary heart disease
  • - Existing or increased risk of venous thromboembolism
  • - Increased risk of hemorrhagic stroke
  • - Increased risk of exercise-induced rhabdomyolysis
  • - Increased risk of atrial fibrillation or heart failure
  • - Previous use of medications known to increase the risk of blood clotting
  • - Induration/Marfan syndrome
  • - Vascular endothelial dysfunction
  • - Previous hemophilia
  • - Cardiopulmonary diseases
  • - Silent myocardial ischemia
  • - Left ventricular dysfunction
  • - Iatrogenic changes in the arterial/venous vessels of the lower extremities
  • - Inserted stents, bypasses
  • - sickle cell anemia
  • Other exclusion criteria:
  • - Pregnancy
  • - Oncological history
  • - Acute or chronic infections
  • - Inability to undergo surgery
  • - Open wounds or infections of the extremities to be trained
  • - Acute compartment syndrome
  • - Acute need for surgery (e.g. incarceration of the meniscus) and significant changes to the post-treatment protocol (e.g. suturing of the meniscus)

研究者

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