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临床试验/NCT05659134
NCT05659134Unknown不适用

Comparison of Alfredson Eccentric and Silbernagel Concentric-eccentric Therapeutical Protocol in Competitive Athletes With Chronic Achilles Tendinopathy

Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年12月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Victorian Institute of Sport Assessment - Achilles (VISA-A)

研究概览

简要总结

A 6-week randomized clinical trial (RCT) with a 46-week follow-up compared the effect of Alfredson and Silbernagel eccentric programs for the treatment of AT. The primary outcome was a change in the Victorian Institute of Sport Assessment - Achilles (VISA-A) scale from baseline to 12 months. The study was approved by the Ethics Committee of the Faculty of Physical Education and Sport, Charles University (Project number: 254/2021). All participants provided written informed consent before participation.

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
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Athletes performing track and field, tennis or football at the competitive level
  • •Age 18 to 40 years
  • •Unilateral Achilles tendinopathy
  • •Pain lasting more than 2 months
  • •Diagnosis of Achilles tendinopathy established by pain on function at the Achilles region and ultrasound assessment (tendon thickening, swollen tendon) by one researcher
  • •Participants trained at least 3 times per week before the onset of Achilles tendinopathy
  • •Less than 3 months without training and less than 6 months from the last competition/match
  • •Wish to return to original sport level
  • •Willing to stop with other treatments 2 weeks before the start of the clinical trial

排除标准

  • •Achilles tendon rupture in past
  • •Corticosteroid injection in Achilles tendon region in last 6 months
  • •Having other lower limb musculoskeletal injuries or surgery in the last 6 months (e.g., muscle rupture, bone fracture)
  • •Having a neurological, systemic or autoimmune disease (e.g., neuropathy, type 1 diabetes, rheumatoid arthritis)

研究组 & 干预措施

Alfredson group (A)

Active Comparator

Participants allocated to the Alfredson exercise program were instructed to exercise twice a day on both legs for 12 months. They performed concentric calf rises (CR) on both legs up and eccentric CR on one leg down.

The protocol contained 15 repetitions and 3 sets on each leg with extended and flexed knee. One session contained 45 reps in the flexed position and 45 reps in the extended position, the total daily number of reps was 180. At the start, the exercises were performed with body weight. Participants could progress by adding the 5, 10 and 15 kg, if they met the criteria. The criteria for adding weight was at least one week of training at the same weight and no disabling pain during or after the exercise during the week.

干预措施: Alfredson protocol (Other)

Silbernagel group (B)

Active Comparator

Participants allocated to the Silbernagel exercise program were instructed to exercise every day with exception of the first week (every other day) for 12 months. The protocol contained 4 phases, which were based on a variety of CR exercises.

The protocol contained concentric and eccentric CR on both legs, CR on one leg, CR in sitting, CR on the step, CR without step, quick rebound CR, CR with added weight and hops on the forefoot.

The daily number of reps for 1st phase was 135, for the 2nd phase was 240, for the 3rd phase was 255 and for the 4th phase was 150. It's performed with body weight, added weight and plyometric loading progressively through all phases (maximal added weight is 15 kilos). To progress to the next phase participant needs to reach pain intensity during and after exercise under 5 from the 10 on the visual analogue scale, morning stiffness should not increase as well as pain during the week.

干预措施: Silbernagel protocol (Other)

结局指标

主要结局

Victorian Institute of Sport Assessment - Achilles (VISA-A)

时间窗: 1 year

The VISA-A questionnaire is the most commonly used outcome in clinical trials of Achilles tendinopathy treatment with proven reliability and validity. It consists of eight questions covering pain, function, daily living and sports activities. The score ranges from 0-100 where 0 means disability (impairment of function and pain of Achilles tendon) and 100 represents no disability.

次要结局

  • Biomechanical properties - stiffness(6 weeks)
  • Structure - micromorphology(6 weeks)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kryštof Voleský

Principal Investigator

Charles University, Czech Republic

研究点 (1)

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