Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Tendon Diameter at the Place of Maximum Tendon Width
研究概览
简要总结
This work is designed as a prospective cohort study, in which the effects of a protocol of 12-week resistance training loading the Achilles tendon in patients with Achilles tendinopathy (AT) will be monitored. It is estimated that at least 20 patients will participate. In addition, there will be a small control group of healthy participants which will not complete the same protocol, but will be monitored for natural changes in same objectives. Group of patients will be instructed to perform a training protocol.
详细描述
The research within one participant will last a total of 26 weeks from the initial to the final examination and will include control measurements at 6 and 12 weeks from the beginning of therapy. Potential participants will be selected based on the recommendation of a specialist doctor and their suitability will be assessed according to the inclusion criteria. They will then be invited to an initial examination. This will include an objective examination by a physiotherapist, a subjective assessment by the patient and an ultrasonographic (USG) examination followed by a micromorphological analysis using special software. At the end of the initial examination, the participant will be informed about training protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •the patient shows symptoms of Achilles tendinopathy (pain, swelling and dysfunction in the area of Achilles tendon), which at least partially limit his quality of life during normal or sporting activities,
- •the patient is in the age group of 18-60 years,
- •the patient has difficulties in only one lower limb; the second, asymptomatic limb will be considered the reference,
- •the patient is not aware of any mechanical damage to the tendon in symptomatic limb in the past (e.g. partial or complete rupture as a result of an injury),
- •the patient has not undergone any treatment aimed at AS in the last 3 months (surgery, corticoid application, plasma therapy, shock waves, physiotherapy, etc.), objective US examination of AS shows structural changes (expansion, neovascularization, focal hypoechoic areas, etc.).
排除标准
- •patient has been diagnosed with a rheumatic disease or a disease of the central nervous system
- •patient is aware of mechanical damage to the Achilles tendon as a result of an injury in the past.
研究组 & 干预措施
Resistance training protocol
Participants in this group will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
干预措施: Achilles Tendon Loading Exercise Protocol According to Silbernagel (Other)
Participants with healthy tendons
Participants in this group are considered healthy based on subjective judgment followed by clinical and ultrasound examination of the Achilles tendon.
In this group, no specific treatment will be performed, only Achilles tendon will be monitored through time.
结局指标
主要结局
Change in Tendon Diameter at the Place of Maximum Tendon Width
时间窗: Change of initial values at 26 weeks follow up after beginning of the therapy.
Measured by tools in ultrasound machine in mm2. In linear view is selected maximal width place, then the tendon diameter is measured using device tools.
Change in Peak Spatial Frequency Radius at the site of Pathology
时间窗: Change of initial values at 26 weeks follow up after beginning of the therapy.
Measured by spatial frequency analysis software from ultrasound picture in mm-1. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the PSFR parameter.
次要结局
- Change in VISA-A Questionnaire Score(Change of initial values at 39 weeks follow up after beginning of the therapy.)
研究者
Stanislav Machač, Ph.D
Academic woorker
University Hospital, Motol