跳至主要内容
临床试验/NCT05814445
NCT05814445招募中不适用

Comparison of Two Muscle Strengthening Programs on the Return-to-exercise Criteria in Patients With Anterior Cruciate Ligament Reconstruction

Instituto Nacional de Rehabilitacion2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
62
试验地点
2
主要终点
Knee flexors muscle strength asymmetry

研究概览

简要总结

Anterior cruciate ligament injury is very common in recreational and elite athletes. It is considered the second most frequent pathology seeing in Sports Medicine Services. After the injury and ACLR, there is a marked decrease in the strength of the knee extensors/flexors muscles. Strength exercise programs are aimed at recovering strength and functionality, however, a low percentage of patients manage to achieve the optimal return-to-exercise criteria. Therefore, it is relevant to design and evaluate exercise programs that allow early recovery of muscle strength and knee functionality. The main purpose of this study is to investigate a neuromuscular exercise program compared with a standard institutional program in the recovery of the strength and functionality of the knee extensor/flexor muscles after ACLR.

详细描述

Study design: this is a 22-week, randomized trial. 62 participants will be recruited from the medical services of the National Institute of Rehabilitation (NIR).

Participants: adults between 20-40 years old, with a body mass index <30.0 kg/mˆ2, history of sports practice immediately prior to the injury, post-operated unilaterally for ACL with the hamstring autograft technique (semitendinosus-gracilis tendons), with full ranges of motion and no edema will be recruited. Participants with multi-ligament knee injuries, with more than 12 months from the injury to surgery or more than 8 months after surgery, with uncompensated metabolic diseases or acute illnesses/infections under treatment will not be recruited.

Intervention: participants will be randomized to 1) neuromuscular or 2) institutional exercise program with computer-generated random numbers. Both programs consist of isotonic open and closed kinetic chain exercises for the hip and knee. The neuromuscular program also includes exercises to improve vastus medialis and lateralis strength, hamstrings, hip flexors and extensors, proprioception, and core stability. On the other hand, the institutional program includes concentric and eccentric knee exercises. Both programs will be performed 3 days/week, 3 sets, 18-22 repetitions for each exercise; the intensity will initiate at 65-75% (1RM), and it will be increased to 75-85%; the workload will be increased 5-10% from the fifth week according to perceived exertion. The exercises will be done with both legs; however, the injured leg will be exercised complementary. The last 6 weeks of the programs correspond to functional exercises according the sport. Every training session will consist of 15 minutes of warm-up, 40-60 minutes of resistance training, and 15 minutes of cool-down; all training sessions will take place in the NIR Sports Medicine therapeutic gym.

The knee flexors/extensors muscle strength will be determined by isokinetic dynamometry (at 60°/s). The knee function will be evaluated by hop tests and agility T-test. The patient's perception of daily functional activities after ACL reconstruction will be assessed by the Lysholm knee score.

For each participant, the study length will be 22 weeks with 66 exercise sessions. The beginning of the study corresponds to session 1 of exercise. Initial evaluation will be performed 5 days prior to the start of the intervention, while final evaluations will be conducted at the end of 22 weeks of follow-up (2 days after the last day of the intervention). Data will be recorded by study investigators.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • History of sports practice immediately prior to the injury
  • Post-operated unilaterally for ACL with the hamstring autograft technique (semitendinosus-gracilis tendons),
  • Full ranges of motion and no edema
  • Body mass index < 30.0 kg/mˆ2

排除标准

  • Multi-ligament knee injuries,
  • More than 12 months from the injury to surgery
  • More than 8 months after surgery
  • Uncompensated metabolic diseases
  • Acute illnesses/infections under treatment

结局指标

主要结局

Knee flexors muscle strength asymmetry

时间窗: 22 weeks

The asymmetry will be calculated as the percentage of the peak knee flexor torque in the involved limb over the peak knee flexor torque in the uninvolved limb, multiplied by 100. Asymmetry % = (peak flexor torque involved limb/ peak flexor torque uninvolved limb) \*100

Knee extensors muscle strength asymmetry

时间窗: 22 weeks

The asymmetry will be calculated as the percentage of the peak knee extensor torque in the involved limb over the peak knee extensor torque in the uninvolved limb, multiplied by 100. Asymmetry % = (peak extensor torque involved limb/peak extensor torque uninvolved limb)\*100

Hop distance asymmetry

时间窗: 22 weeks

The asymmetry will be calculated as the percentage of the hop distance (one leg hop, triple hop, or cross-over hop) in the involved limb over the hop distance in the uninvolved limb, multiplied by 100. Asymmetry % = (hop distance involved limb/hop distance uninvolved limb)\*100

Agility T-test time

时间窗: 22 weeks

The time will be determined with data obtained from T-test; the fastest time will be recorded.

次要结局

  • Leg muscle quality index (MQIleg)(Baseline and 22 weeks)
  • Lysholm knee score(Baseline and 22 weeks)

研究者

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

Ariadna del Villar Morales

Principal Investigator

Instituto Nacional de Rehabilitacion

研究点 (2)

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