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临床试验/NCT04600661
NCT04600661Unknown不适用

LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS

Mai Mohamed Abdelkader Abdallah0 个研究点目标入组 63 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
63
主要终点
Muscle strength

研究概览

简要总结

This study will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy.

详细描述

PURPOSE:

This study will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy.

BACKGROUND:

Patients with knee OA may have reduction of tolerance of the high-load programs which is recommended for eliciting strength gains (Messier et al., 2013). Thus, for reducing disease risk and enhancing physical function, there is a need for effectively strengthening the quadriceps muscle while limiting pain and adverse joint loading in people with knee OA (Segal et al., 2015). Blood flow restriction (BFR) with low-load resistance training (LLRT) is an alternative to traditional strength training that can be used in knee OA with minimal adverse joint loading that is normally found in traditional strengthening programs(Pope et al., 2013). It is attained through applying pressure externally with a pneumatic cuff or tourniquet. The applied pressure occludes venous outflow while maintaining arterial inflow with intent to promote blood pooling in the capillary beds of the limb muscles distal to the tourniquet (Slysz et al., 2016). Kubota et al., (2008), showed that BFR can be applied during periods of immobilization to decrease disuse muscle atrophy of limbs. Also it can be combined with exercise which enhances muscular development. Resistance exercise appears to provide great muscular gains when combined with BFR (Slysz et al., 2016).

HYPOTHESES:

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 (Investigator, Outcomes Assessor)

盲法说明

Sixty Three patients of both genders with mild to moderate unilateral tibiofemoral OA, with age range from 45-60 years will be randomly assigned to 1 of 3 groups using opaque, sealed envelopes, each containing the name of one of the groups. Each patient will sign an informed consent before starting the study (Appendix III). All patients will be referred by the orthopedic surgeon who will diagnose knee OA based on clinical and radiological examination. The investigator will be blinded

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age range from 45-60 years (Segal et al., 2015).
  • Walk with painful knee OA without assistive devices (Bryk et al., 2016).
  • Mild to moderate unilateral OA grade II-III (K/L) (Bryk et al., 2016).
  • BMI < 30 kg/m² (not being classified as obese) (Bryk et al., 2016).
  • Never participated in resistance training in the 3 months prior to their appointment (Jan et al., 2008)

排除标准

  • Severe knee OA (grade IV according to K/L classification).
  • Bilateral knee OA.
  • Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee.
  • Repeated treatment with steroids.
  • Secondary knee OA.
  • Received joint replacement surgery in either Knee or/and hip.
  • Cardiovascular and neuromuscular disorders
  • Diabetic patients
  • Psychiatric disorders.

结局指标

主要结局

Muscle strength

时间窗: 3 months

Hand-Held Dynamometer for measuring muscle strength

次要结局

  • Knee joint function(3 months)

研究者

发起方
Mai Mohamed Abdelkader Abdallah
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mai Mohamed Abdelkader Abdallah

Masters

Cairo University

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