Effect of Collagen Supplementation on Tendinopathy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Randomized placebo-controlled intervention study with follow-up after one month
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Collagen + heavy slow resistance group Daily collagen supplementation + heavy slow resistance training three times weekly for 12 weeks. |
Dietary Supplement: Hydrolyzed collagen
Hydrolyzed collagen supplementation twice daily
Other: Heavy slow resistance training
Heavy slow resistance training 3 times weekly
|
| Experimental: Placebo + heavy slow resistance group Daily placebo supplementation + heavy slow resistance training three times weekly for 12 weeks. |
Other: Heavy slow resistance training
Heavy slow resistance training 3 times weekly
Dietary Supplement: Placebo
Placebo supplementation twice daily
|
Outcome Measures
Primary Outcome Measures
- Maximal tendon pain during the past week at preferred sporting activity [Baseline-12 weeks]
Change from baseline - 12 weeks using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
Secondary Outcome Measures
- Maximal tendon pain during the past week at preferred sporting activity [Baseline, 6 weeks + 6 month follow-up]
Change from baseline - 6 weeks + 1 month follow-up using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
- Self-reported activity level of sporting activities (hours/week) [Baseline, 6 and 12 weeks + 6 month follow-up]
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
- Single-leg decline squat (SLDS) test [Baseline - 12 weeks]
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)
- Jump test [Baseline - 12 weeks]
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)
- Treatment satisfaction [12 weeks]
Participants will be asked after the intervention period whether they were satisfied or not with the treatment (dichotom : Yes vs. No)
- Collagen supplement [Baseline - 12 weeks + 6 month follow-up]
Participants will be asked on a weekly basis if taken their collagen supplement : Questionnaire (dichotom : Yes vs. No)
- Adverse events (e.g. allergies, gastro-intestinal side effects) related to supplement ingestion [Baseline - 12 weeks + 6 month follow-up]
Participants will self-report adverse events during intervention period and at 6 month follow-up
- Return-to-sport activities [Baseline - 12 weeks + 6 month follow-up]
Participants will self-report Return-to-sport activities during intervention period and at 6 month follow-up (dichotom : Yes vs. No)
- 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]
Patient reported outcome regarding symptoms, function and the ability to participate in sports
- Change from baseline Foot function index - Plantaris questionnaire at 12 wks [Baseline, 6 and 12 weeks + 6 month follow-up]
Patient reported outcome regarding symptoms, function and the ability to participate in sports
- Tendon Doppler activity using Ultrasonography power Doppler [Baseline - 12 weeks]
Using Ultrasonography, we will measure Doppler activity within the affected tendon and use ImageJ for the analysis
- 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]
Eligibility Criteria
Criteria
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
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Uni- or bilateral tendinopathy symptoms > 3 months
Exclusion Criteria:
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Previous tendon surgery
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Diabetes
-
Arthritis
-
Corticosteroid injection for tendinopathy within the last 3 months
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Any form of tendon injection within the last 3 months
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Smoking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Physical and Occupational Therapy/Institute of Sports Medicine Copenhagen, Bispebjerg Hospital | Copenhagen NV | Denmark | 2400 |
Sponsors and Collaborators
- Bispebjerg Hospital
- Team Denmark
Investigators
- Study Director: Christian Couppé, PhD, Institute of Sports Medicine
- Principal Investigator: Kasper Dideriksen, PhD, Team Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-16019857