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临床试验/NCT03861572
NCT03861572已完成不适用

Eccentric Training Effects on Functionality and on Triceps Surae Neuromechanical Properties After Achilles Tendon Surgical Repair

Federal University of Rio Grande do Sul2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
2
主要终点
Tendon stiffness

研究概览

简要总结

Early rehabilitation protocols have been studied in Achilles tendon (AT) rupture patients, but deficits in tendon biomechanical properties have been observed several years after the injury. AT rupture patients are unable to return to their previous levels of physical activity. They present deleterious adaptations in the plantar flexor muscles that lead to functional deficits, and deficits in the tendon's structural and mechanical properties. Eccentric contractions have been suggested to recover these muscle properties. This contraction is known to produce higher force compared to isometric and concentric contractions, and increases tendon stiffness. However, there is a lack of studies showing the effects of the eccentric training in AT rupture rehabilitation. We want to know if an isokinetic eccentric training program will determine the desired adaptations on triceps surae muscle-tendon unit's properties in patients subjected to the AT surgical repair. More specifically, the aim of this study is verifying the effects of a 12-week eccentric training program on triceps surae muscle-tendon unit's properties in subjects that were subjected to the AT surgical repair. 30 subjects will be randomized in two groups: (1) isokinetic eccentric training; and (2) traditional eccentric training control group. All participants will be submitted to a four-week control period, followed by a 12-week period of training for the plantar flexor muscles. Neuromuscular system properties, AT biomechanical properties and functional tests will be evaluated. Participants will be evaluated in four moments: at baseline; after 4, 8 and 12 weeks of rehabilitation. Tendon mechanical (stiffness, stress, strain), material (Young's modulus) and morphological (cross-sectional area and tendon length) properties; muscle architecture (thickness, pennation angle and fascicle length); and functional tests (heel rise resistance and height) will be analyzed between groups and periods. Effects and interactions will be analyzed with ANOVA two-way. Clinical effects will be analyzed using effect size and magnitude-based inferences.

详细描述

Detailed Description: Early rehabilitation protocols have been studied in Achilles tendon (AT) rupture patients, but deficits in tendon biomechanical properties have been observed several years after the injury. AT rupture patients are unable to return to their previous levels of physical activity. They present deleterious adaptations in the plantar flexor muscles that lead to functional deficits and deficits in the tendon structural and mechanical properties. Deficits in calf muscle endurance and strength remained 7 years after the injury. In this regards, eccentric contractions are recommended to recover muscle morphology and mechanical properties. This contraction type produces higher force compared to isometric and concentric contractions, and increases tendon stiffness. However, there is a lack of studies showing the effect of the eccentric training in AT rupture rehabilitation. We want to know if an isokinetic eccentric training program will determine the desired adaptations on triceps surae muscle-tendon unit's properties in patients subjected to the AT surgical repair. More specifically, the aim of this study is verifying the effects of a 12-week eccentric training program on triceps surae muscle-tendon unit's properties in subjects that were subjected to the AT surgical repair. Our hypothesis is that the eccentric training program will (1) increase the ability to produce muscular strength; (2) will produce an increase in gastrocnemius and soleus muscles thickness, fascicle length, and pennation angle; (3) will increase AT stiffness and Young's modulus; (4) will increase ankle functionality; (5) will improve the patient's quality of life. Finally, we expect that the abovementioned changes from isokinetic eccentric training will be greater than those from the traditional eccentric control group that will be subjected to 12 weeks of plantar flexor training with weights. 30 subjects will be randomized in two groups: (1) isokinetic eccentric training; and (2) traditional eccentric training control group. All participants will be submitted to a four-week control period, followed by a 12- week period of training for the plantar flexor muscles. Neuromuscular system properties, AT biomechanical properties and functional tests will be evaluated. Participants will be evaluated in four moments: at baseline; after 4, 8 and 12 weeks of rehabilitation. Tendon mechanical (stiffness, stress, strain), material (Young's modulus) and morphological (cross sectional area and tendon length) properties; muscle architecture (thickness, pennation angle and fascicle length); and functional tests (heel rise resistance and height) will be analyzed between groups and periods. Effects and interactions will be analyzed with ANOVA two- way (group x period). Clinical effects will be analyzed using effect size (Cohen's d) and magnitude-based inferences.

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

Raters will be blinded to the participants' allocation in each group.

入排标准

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

入选标准

  • Participants will be male and female subjects who suffered total acute Achilles tendon rupture, and which underwent surgical repair. In addition, to participate in this study all volunteers will need to present medical and/or physiotherapeutic release for physical/sports activities practice.

排除标准

  • Volunteers that did not have Achilles tendon surgical reconstruction, that did not present medical and/or physiotherapeutic release for physical/sports activities, who have participated in strength training program for the plantar flexors in the last 6 months, patients with diabetic diseases, as well as those with difficulty for understanding and/or executing the test and training protocols in the isokinetic dynamometer will be excluded.

结局指标

主要结局

Tendon stiffness

时间窗: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training

Tendon stiffness will be obtained by calculating the slope in the last 40% of the linear region of the force-deformation curve.

Vertical countermovement jump

时间窗: First baseline evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training

Vertical jump will be recorded using cameras and maximal vertical height will be measured using Kinovea software.

Triple hop test

时间窗: First baseline evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training

Maximal distance of a triple unilateral jump will be measure with a metric tape.

Tendon Young's modulus

时间窗: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training

Tendon elastic modulus (Young's modulus) will be obtained by calculating the slope in the last 40% of the linear region of the stress-strain curve.

Resistance to plantar flexion test

时间窗: First baseline evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training

The number of times, as well as the elevation height, will be used for data analysis. Height will be recorded and will be analyzed with Kinovea software.

次要结局

  • Calf muscle perimetry(First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training)
  • Muscle echo-intensity(First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training)
  • Achilles tendon cross-sectional area(First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training)
  • Resistance to plantar flexion test(First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training)
  • Achilles tendon length(First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training)
  • Muscle strength(First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training)
  • Muscle Architecture(First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training)
  • Muscle Activation(First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training)

研究者

发起方
Federal University of Rio Grande do Sul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Aurélio Vaz, PhD

Principal Investigator

Federal University of Rio Grande do Sul

研究点 (2)

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