Effect of Collagen Supplementation on Tendinopathy in Elite Athletes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- Maximal tendon pain during the past week at preferred sporting activity
Study Overview
Brief Summary
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.
Detailed Description
Randomized placebo-controlled intervention study with follow-up after one month
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Previous tendon surgery
- •Arthritis
- •Corticosteroid injection for tendinopathy within the last 3 months
- •Any form of tendon injection within the last 3 months
Outcomes
Primary Outcomes
Maximal tendon pain during the past week at preferred sporting activity
Time Frame: Baseline-12 weeks
Change from baseline - 12 weeks using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
Secondary Outcomes
- 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)
Investigators
Christian Couppé
Principal Investigator
Bispebjerg Hospital