Effectiveness of Eccentric Exercise Compared to Isometric Exercise in Athletes With Chronic Achilles Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Morphological tendon properties, Tendon cross sectional area (CSA)
研究概览
简要总结
This is a prospective single blinded randomised controlled trial with a 12-week intervention period and a half-year follow-up period. The main purpose is to determine the effects of isometric exercise on mechanical, morphological and functional tendon properties versus eccentric exercise in chronic Achilles tendinopathy.
详细描述
This research project was funded by means of the "Bundesinstitut für Sportwissenschaft" based on a resolution of the German Federal Parliament.
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 (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
- 否
入选标准
- •Chronic (3 months or more) condition of unilateral Achilles tendinopathy confirmed by a medical doctor based on ultrasound
- •age 18-60
- •VISA-A Score of at least 80
排除标准
- •bilateral tendinopathy
- •any systemic or inflammatory diseases (i. e. Diabetes, Arthritis)
- •surgery on lower extremities in the past
- •corticoid injections in the last 12 months
结局指标
主要结局
Morphological tendon properties, Tendon cross sectional area (CSA)
时间窗: At baseline and 12 weeks after
Equipment Magnetic resonance imaging (MRI) (0.25 T MR Scanner (Esaote, G-Scan, Italy), T1-Gewichtung, 3D HYCE (GR) Sequency, TR 10 ms, TE 5 ms, flip angle 80°, layer thickness 3 mm, 1 Anregung) Software OsiriX (Pixmeo SARL, Version 2.5.1., Schweiz) Tendon thickness / cross sectional area (CSA) in square millimeter (mm²) through MRI, manually outlined via Software OsiriX (Pixmeo SARL, Version 2.5.1., Schweiz). The mean value of three measurements of the same image will be used for analysis. In order to demonstrate local changes within the tendon, CSA will be shown in 10% intervals relative to the total length of the tendon.
Mechanical tendon properties, Tendon stiffness
时间窗: At baseline and 12 weeks after
Equipment Dynamometer (Biodex System 3, Medical Systems Inc., USA), optical motion capture system with eight cameras with a frequency of 250 Hertz (Hz) (Vicon Nexus, version 1.7.1., Vicon Motion Systems, UK), electromyography (Myon m320RX, Myon AG, Schweiz) and a linear ultrasound (7.5 Megahertz (MHz), ESAOTE MyLab 60) Tendon stiffness in Newton per mm (N/mm) with support of tendon force in Newton (N)
Mechanical tendon properties, Modulus
时间窗: At baseline and 12 weeks after
Equipment Dynamometer (Biodex System 3, Medical Systems Inc., USA), optical motion capture system with eight cameras with a frequency of 250 Hertz (Hz) (Vicon Nexus, version 1.7.1., Vicon Motion Systems, UK), electromyography (Myon m320RX, Myon AG, Schweiz) and a linear ultrasound (7.5 Megahertz (MHz), ESAOTE MyLab 60) Modulus in Pascal (Pa) based on tendon stress (Pa) and tendon elongation in millimeter (mm)
Morphological tendon properties, Tendon length
时间窗: At baseline and 12 weeks after
Equipment Magnetic resonance imaging (MRI) (0.25 T MR Scanner (Esaote, G-Scan, Italy), T1-Gewichtung, 3D HYCE (GR) Sequency, TR 10 ms, TE 5 ms, flip angle 80°, layer thickness 3 mm, 1 Anregung) Software OsiriX (Pixmeo SARL, Version 2.5.1., Schweiz) Tendon length im millimeter (mm) through MRI, manually outlined via Software OsiriX (Pixmeo SARL, Version 2.5.1., Schweiz).The mean value of three measurements of the same image will be used for analysis.
Morphological tendon properties, Tendon vascularization level
时间窗: At baseline and 12 weeks after
Equipment Linear ultrasound (7.5 Megahertz (MHz), ESAOTE MyLab 60) Software Doppler Flow Image Analyser version 1.01 Vascularization level of the tendon via Color Doppler (CD) ultrasound CD signals will be estimated through the total number of coloured pixels within the area of interest (3x7 centimeters (cm) with the help of Software Doppler Flow Image Analyser version 1.01 (http://www.gtech.dk).
次要结局
- Clinical functional score(At baseline, 12 weeks and six months after)
- Interleukin 6 level(At baseline and 12 weeks after)
- Functional tendon properties, Ground contact time(At baseline and 12 weeks after)
- Functional tendon properties, Maximum jump height(At baseline and 12 weeks after)
- Pain level via Visual Analogue Scale (VAS)(At baseline, 12 weeks and six months after)
研究者
Goran Radovanovic
Principal Investigator
Humboldt-Universität zu Berlin