Actively Recruiting
Led by Gelderse Vallei Hospital · Updated on 2024-09-26
76
Participants Needed
1
Research Sites
52 weeks
Total Duration
Patellar tendinopathy (PT) is a common overuse injury affecting the tendon in athletes, sometimes causing long breaks from sports and limiting performance and health benefits. This research evaluates whether adding oral hydrolysed collagen and vitamin C supplements to standard care, which includes education, load management, and tendon loading exercises, improves recovery in athletes with PT. The study is a randomized controlled trial designed to assess the effect of the supplement on tendon symptoms and function over time. The trial compares two groups: one receiving a nutritional supplement containing 10g hydrolysed collagen and 40mg vitamin C daily for 24 weeks, and the other receiving a placebo supplement made of maltodextrin. Both groups follow a structured progressive tendon loading exercise program and receive education and load management advice. The exercise program spans 24 weeks and is based on pain limits, aiming to improve tendon strength and function. Participants will complete questionnaires assessing tendon pain and function at multiple times up to one year, including the VISA-P score. Additional evaluations include functional tests, advanced imaging of the tendon, blood tests for amino acids and inflammation, dietary assessments, and weekly records of exercise and supplement adherence. These measures help researchers understand how the supplement and exercise program affect tendon health and recovery over time.
CONDITIONS
Effect of Collagen/Vitamin C in Jumper's Knee; a RCT
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants take a daily nutritional supplement of hydrolysed collagen and vitamin C or a placebo, combined with education, load management advice, and a progressive tendon loading exercise program performed three times per week.
Weekly visits for up to 24 weeks for compliance and progress monitoring
Duration - Up to 28 weeks after treatment ends, totaling 52 weeks from start
Participants complete assessments including VISA-P scores, pain tests, imaging, stiffness measurements, blood tests, and dietary habits up to 52 weeks after starting treatment.
Visits at 6, 12, 18, 24, and 52 weeks for assessments
Total: 1 location
1
Gelderse Vallei Hospital
Ede, Gelderland, Netherlands, 6716RP
Actively Recruiting
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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L van Dam, R Terink, M Mensink...
https://pubmed.ncbi.nlm.nih.gov/38017500