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.
Randomized placebo-controlled intervention study with follow-up after one month
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
Hydrolyzed collagen supplementation twice daily
Heavy slow resistance training 3 times weekly
Placebo supplementation twice daily
Department of Physical and Occupational Therapy/Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Copenhagen NV, Denmark
Maximal tendon pain during the past week at preferred sporting activity
Change from baseline - 12 weeks using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
Time frame: Baseline-12 weeks
Maximal tendon pain during the past week at preferred sporting activity
Change from baseline - 6 weeks + 1 month follow-up using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
Time frame: Baseline, 6 weeks + 6 month follow-up
Self-reported activity level of sporting activities (hours/week)
Participants will self-report how many hours a week they are performing sporting activities: We will monitor to see if they decrease, maintain or increase hours per week of sporting activity
Time frame: Baseline, 6 and 12 weeks + 6 month follow-up
Single-leg decline squat (SLDS) test
A reliable patellar tendon pain provocation test, will be used to assess pain during function using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
Time frame: Baseline - 12 weeks
Jump test
A reliable Achilles/Plantaris tendon pain provocation test, will be used to assess pain during function using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
Time frame: Baseline - 12 weeks
Treatment satisfaction
Participants will be asked after the intervention period whether they were satisfied or not with the treatment (dichotomal : Yes vs. No)
Time frame: 12 weeks
Collagen supplement
Participants will be asked on a weekly basis if taken their collagen supplement : Questionnaire (dichotomal : Yes vs. No)
Time frame: Baseline - 12 weeks + 6 month follow-up
Adverse events (e.g. allergies, gastro-intestinal side effects) related to supplement ingestion
Participants will self-report adverse events during intervention period and at 6 month follow-up
Time frame: Baseline - 12 weeks + 6 month follow-up
Return-to-sport activities
Participants will self-report Return-to-sport activities during intervention period and at 6 month follow-up (dichotomal : Yes vs. No)
Time frame: Baseline - 12 weeks + 6 month follow-up
Change from baseline Victorian Institute of Sports Assessment - Patella/Achilles Questionnaire (VISA-P/A) at 12 wks
Patient reported outcome regarding symptoms, function and the ability to participate in sports
Time frame: Baseline, 6 and 12 weeks + 6 month follow-up
Change from baseline Foot function index - Plantaris questionnaire at 12 wks
Patient reported outcome regarding symptoms, function and the ability to participate in sports
Time frame: Baseline, 6 and 12 weeks + 6 month follow-up
Tendon Doppler activity using Ultrasonography power Doppler
Using Ultrasonography, we will measure Doppler activity within the affected tendon and use the program ImageJ for the analysis
Time frame: Baseline - 12 weeks
Tendon thickness measured using Ultrasonography
Time frame: Baseline - 12 weeks
Pain rating on Numeric Rating Scale (NRS; 0 = no pain; 10 = worst imaginable pain) during training.
Time frame: Baseline, 6 and 12 weeks + 6 month follow-up
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