Tendinopathy: Optimal Time for Management Through Exercise (TENDOTIME) - a Randomised Controlled Study Comparing Targeted Training Performed Morning and Late Afternoon in a 12-week Intervention Program on Chronic Patellar Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Patient perception VISA-P
研究概览
简要总结
The study is a 12-week human study where 60 participants with chronic patellar tendinopathy (more than 3 months symptoms duration) are randomised to undergo 12 weeks of targeted resistance exercise either in the morning or in the late afternoon. The overall aim is to investigate when the best time of the day to perform muscular strength training therapy towards tendinopathy is. The study will also include 10 healthy controls who will not perform any exercise training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sports active men and women
- •Age (18-55) years old
- •BMI (18.5-30)
- •Uni- or bilateral patellar tendinopathy
- •Symptom onset >90 days ago
排除标准
- •Patellar tendinopathy longer than 24 months
- •Previous surgery in the knee on the ipsilateral side
- •Corticosteroid injection in the patellar tendon on the ipsilateral side within the last 6 months
- •Any confounding diagnosis to the knee joint
- •Known arthritis
- •Known diabetes
- •Known rheumatic disorders
- •Inability to follow rehabilitation or complete follow-ups
- •Enrolled in a resistance based-rehabilitation program for the affected patellar tendon within the previous 3 months
- •Have an occupation where it is not feasible to avoid pain provoking tasks
- •Pregnancy
- •Have sleeping disorders or disruptions, e.g., night shift work
- •Use of medicines or supplements known to affect collagen synthesis or sleep
研究组 & 干预措施
Morning exercise
Three sessions per week of targeted resistance exercise targeting the quadriceps muscles performed between 6:00 and 8:00 for 12 weeks.
干预措施: Resistance training for knee extensors (Other)
Late afternoon exercise
Three sessions per week of targeted resistance exercise targeting the quadriceps muscles performed between 16:00 and 18:00 for 12 weeks.
干预措施: Resistance training for knee extensors (Other)
Healthy control
Healthy individuals without tendinopathy as controls for the transcriptomics and proteomics analyses.
结局指标
主要结局
Patient perception VISA-P
时间窗: Change from baseline at week 12.
Change in Victorian Institute of Sports Assessment - patella (VISA-P) total score. The VISA-P asses symptoms, function and the ability to participate in sport. It consists of 8 questions, with a maximum score of 100 indicating the person is asymptomatic and fully per-forming and lower scores indicating more symptoms and limitations of function and activity.
次要结局
- Patient perception VISA-P truncated(Change from baseline at week 12 and 52.)
- Patient perception VISA-P(Change from baseline at week 52.)
- Self-reported satisfaction (PASS)(Change from baseline at week 12 and 52.)
- Counter movement jump height(Change from baseline at week 52.)
- Pain during single-leg decline squat (SLDS)(Change from baseline at week 12 and 52.)
- Self-reported improvement (GROC)(Change from baseline at week 12 and 52.)
- Ultrasonography - tendon thickness(Change from baseline at week 12 and 52.)
- Ultrasonography - power Doppler(Change from baseline at week 12 and 52.)
- Global expression of genes(Change from baseline at week 12, compared to healthy controls.)
- Lean mass by dual-energy X-ray absorptiometry(Change from baseline at week 12.)
- Blood samples(Change from baseline at week 12, compared to healthy controls.)
- Expression of circadian clock genes(Change from baseline at week 12, compared to healthy controls.)
- Expression of extracellular matrix (ECM) and ECM regulator genes(Change from baseline at week 12, compared to healthy controls.)
- Histochemical staining of tendon sections(Change from baseline at week 12, compared to healthy controls.)
- Spatial changes of gene expression(Change from baseline at week 12, compared to healthy controls.)
- Spatial changes of extracellular matrix protein levels(Change from baseline at week 12, compared to healthy controls.)
研究者
Chloé Yeung
Senior Researcher
Bispebjerg Hospital