Effect of Collagen Supplementation on Tendinopathy in Elite Athletes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Maximal tendon pain during the past week at preferred sporting activity
研究概览
简要总结
Tendon injuries represent a significant problem in elite athletes. Therefore, prevention and effective treatment of tendon overload injury/tendinopathy is important. Among different treatment options, heavy-slow loading based rehabilitation is considered among the most efficient treatments in athletes. In this study, we will investigate if supplementation with hydrolyzed collagen in combination with a heavy-slow loading based 12 weeks rehabilitation regime can improve treatment of tendon overload injury/tendinopathy. The investigators will examine elite athletes with overload injury/tendinopathy with regards to symptoms (pain, function), tendon morphology (ultrasonography), and vascularization (Doppler US). The investigators hypothesize that collagen supplementation can have an improving effect on tendon pain and function. Thus, the investigation will show if a rehabilitation regime of collagen supplementation combined with heavy-slow mechanical loading can improve tendon healing compared to mechanical loading alone.
详细描述
Randomized placebo-controlled intervention study with follow-up after one month
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Elite athletes
- •18-40 years old
- •Exercise related tendon pain on one or both legs
- •Soreness during physical examination of tendon upon palpation
- •Uni- or bilateral tendinopathy symptoms > 3 months
排除标准
- •Previous tendon surgery
- •Arthritis
- •Corticosteroid injection for tendinopathy within the last 3 months
- •Any form of tendon injection within the last 3 months
结局指标
主要结局
Maximal tendon pain during the past week at preferred sporting activity
时间窗: Baseline-12 weeks
Change from baseline - 12 weeks using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
次要结局
- Maximal tendon pain during the past week at preferred sporting activity(Baseline, 6 weeks + 6 month follow-up)
- Self-reported activity level of sporting activities (hours/week)(Baseline, 6 and 12 weeks + 6 month follow-up)
- Single-leg decline squat (SLDS) test(Baseline - 12 weeks)
- Jump test(Baseline - 12 weeks)
- Treatment satisfaction(12 weeks)
- Collagen supplement(Baseline - 12 weeks + 6 month follow-up)
- Adverse events (e.g. allergies, gastro-intestinal side effects) related to supplement ingestion(Baseline - 12 weeks + 6 month follow-up)
- Return-to-sport activities(Baseline - 12 weeks + 6 month follow-up)
- Change from baseline Victorian Institute of Sports Assessment - Patella/Achilles Questionnaire (VISA-P/A) at 12 wks(Baseline, 6 and 12 weeks + 6 month follow-up)
- Change from baseline Foot function index - Plantaris questionnaire at 12 wks(Baseline, 6 and 12 weeks + 6 month follow-up)
- Tendon Doppler activity using Ultrasonography power Doppler(Baseline - 12 weeks)
- Tendon thickness measured using Ultrasonography(Baseline - 12 weeks)
- Pain rating on Numeric Rating Scale (NRS; 0 = no pain; 10 = worst imaginable pain) during training.(Baseline, 6 and 12 weeks + 6 month follow-up)
研究者
Christian Couppé
Principal Investigator
Bispebjerg Hospital