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临床试验/NCT03517254
NCT03517254Unknown不适用

Effect of Oral Complementation of Glutamine on Knee Strengths Indicators in Adult Patients With Anterior Cruciate Ligament Reconstruction. A Double-blinded, Randomized Controlled Trial

Instituto Nacional de Rehabilitacion2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Change in torque peak of quadriceps femoris and hamstring

研究概览

简要总结

After an Anterior Cruciate Ligament Reconstruction by surgery, the most important muscle of the knee, called quadriceps femoral, loses strength in more than 60% of cases, which if not corrected can progress to osteoarthritis in up to 80% of patients, compromising their quality of life.

The main treatment for loss of muscle strength in these patients is rehabilitation which includes strength and endurance exercises.However, in some cases, amino acids such as Glutamine (Gln) have been employed as an aid to recover muscle strength, but the evidence on this topic is not consistent and is inconclusive. Therefore, the main purpose of this study is to investigate if the oral complementation with Glutamine in combination with strength and resistance training can improve the muscle strength of the quadriceps femoral in patients with anterior cruciate ligament reconstruction compared with those receiving a placebo after six weeks of intervention.

详细描述

The study design is a randomized, double-blind and controlled trial. A total of 50 adult men will be recruited from medical departments of the National Institute of Rehabilitation in Mexico City.

Patients: Fifty men 20 to 50 years old, between 15 to 19 weeks after surgical reconstruction of anterior cruciate ligament and moderate loss of muscle strength of knee (assessment with computerized dynamometer), will be recruited from the Sport Rehabilitation department, and the treatment will be carried out in the Sport Medicine area, both of the National Institute of Rehabilitation in Mexico City. Patients with diabetes, obesity, hypertension, kidney or liver diseases or with glucocorticoid treatment, and athletes will not be included.

Intervention: The sample will be randomized in two groups. At the beginning and at the end of the training session, the experimental group will receive 10 grams of glutamine, and the control group will receive 10 grams of placebo (maltodextrin), both dissolved in 120 milliliters of water and all participants will not be aware of the supplement content.

Both groups will participate in the same standardized resistance training program, to ensure progression (or regression if necessary) to all training components and adherence to the intervention, each participant will do the training program in a therapeutic gym of Sport Medicine area three times per week, during 6 weeks of follow-up. One training session consists of 20 minutes of warm-up, 40 to 60 minutes of aerobic and anaerobic exercises and 15 minutes of cooling down. The exercises of the lower part of the body consist in 3 sets of 10 repetitions for healthy knees, and 12 repetitions for knees with anterior cruciate ligament reconstruction in a modular leg press, leg curl and leg extension machine.

All participants, irrespective of the supplement that they receive, will be closely monitored by a physician specialist in Sport Medicine and a nutritionist, who will give a dietary program to standardize protein consumption. Status nutritional will be assessed according to Body Mass Index [(BMI) 19.9-24.9, 25-29.9].

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients between 15 to 19 weeks after surgical reconstruction of anterior cruciate ligament
  • Moderate loss of muscle strength of knee (assessment with computerized dynamometer)
  • Perform the training sessions in the hospital
  • No athletes
  • Index Body Mass: 20 - 30 kg/m²
  • Without consumption of supplements based on amino acids in the last 6 months
  • To sign informed consent letter

排除标准

  • Diabetes mellitus I or 2
  • Liver and renal diseases
  • Dyslipidemia
  • Glucocorticoid consumption
  • Active cancer
  • Glutamine allergy or intolerance
  • Planning to lose weight/go on special diet

结局指标

主要结局

Change in torque peak of quadriceps femoris and hamstring

时间窗: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up (1 day after the last training session)

Measurement by computer dynamometer and expressed in Newton/meters at 60° angular speed.

Change hamstring/quadriceps ratio

时间窗: Baseline (admission to Sport Medicine) and 6 weeks after the follow-up (1 day after the last training session)

Measurement by computer dynamometer and expressed in percentages at 60° angular speed.

次要结局

  • Changes in blood Aspartate aminotransferase (AST) levels(Baseline (admission to Sport Medicine) and 6 weeks after the follow-up)
  • Energy intake(Baseline (admission to Sport Medicine), 3 and 6 weeks after the follow-up])
  • Changes in blood triglycerides levels(Baseline (admission to Sport Medicine) and 6 weeks after the follow-up)
  • Changes in blood Alkaline phosphatase (ALP) levels(Baseline (admission to Sport Medicine) and 6 weeks after the follow-up)
  • Change in thigh circumference (In operated knee and the non-operated knee)(Baseline (admission to Sport Medicine) and 6 weeks after the follow-up (1 day after the last training session))
  • Protein intake(Baseline (admission to Sport Medicine), 3 and 6 weeks after the follow-up])
  • Changes in blood High Density Lipoprotein-Cholesterol (HDL-C) levels(Baseline (admission to Sport Medicine) and 6 weeks after the follow-up)
  • Changes in blood glucose levels(Baseline (admission to Sport Medicine) and 6 weeks after the follow-up)
  • Changes in blood Low density Lipoprotein-Cholesterol (LDL-C) levels(Baseline (admission to Sport Medicine) and 6 weeks after the follow-up)
  • Changes in total blood cholesterol levels(Baseline (admission to Sport Medicine) and 6 weeks after the follow-up)
  • Changes in blood alanine aminotransferase (ALT) levels(Baseline (admission to Sport Medicine) and 6 weeks after the follow-up)
  • Changes in blood Gamma-glutamyl transferase (GGT) levels(Baseline (admission to Sport Medicine) and 6 weeks after the follow-up)

研究者

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

Sandra Hernández Valencia

Principal investigator

Instituto Nacional de Rehabilitacion

研究点 (2)

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