Clinical trial NCT04578418: Effect of Collagen Supplementation on Tendinopathy
Official title: Effect of Collagen Supplementation on Tendinopathy in Elite Athletes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tendinopathy
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Team Denmark
name: University of Aarhus
First posted: 2020-10-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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
* Uni- or bilateral tendinopathy symptoms \> 3 months

Exclusion Criteria:

* Previous tendon surgery
* Diabetes
* Arthritis
* Corticosteroid injection for tendinopathy within the last 3 months
* Any form of tendon injection within the last 3 months
* Smoking

Primary outcomes:
measure: Maximal tendon pain during the past week at preferred sporting activity
timeFrame: Baseline-12 weeks
Secondary outcomes:
measure: Maximal tendon pain during the past week at preferred sporting activity
timeFrame: Baseline, 6 weeks + 6 month follow-up
measure: Self-reported activity level of sporting activities (hours/week)
timeFrame: Baseline, 6 and 12 weeks + 6 month follow-up
measure: Single-leg decline squat (SLDS) test
timeFrame: Baseline - 12 weeks
measure: Jump test
timeFrame: Baseline - 12 weeks
measure: Treatment satisfaction
timeFrame: 12 weeks
measure: Collagen supplement
timeFrame: Baseline - 12 weeks + 6 month follow-up
measure: Adverse events (e.g. allergies, gastro-intestinal side effects) related to supplement ingestion
timeFrame: Baseline - 12 weeks + 6 month follow-up
measure: Return-to-sport activities
timeFrame: Baseline - 12 weeks + 6 month follow-up
measure: Change from baseline Victorian Institute of Sports Assessment - Patella/Achilles Questionnaire (VISA-P/A) at 12 wks
timeFrame: Baseline, 6 and 12 weeks + 6 month follow-up
measure: Change from baseline Foot function index - Plantaris questionnaire at 12 wks
timeFrame: Baseline, 6 and 12 weeks + 6 month follow-up
measure: Tendon Doppler activity using Ultrasonography power Doppler
timeFrame: Baseline - 12 weeks
measure: Tendon thickness measured using Ultrasonography
timeFrame: Baseline - 12 weeks
measure: Pain rating on Numeric Rating Scale (NRS; 0 = no pain; 10 = worst imaginable pain) during training.
timeFrame: Baseline, 6 and 12 weeks + 6 month follow-up
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Department of Physical and Occupational Therapy/Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Study officials:
affiliation: Institute of Sports Medicine
name: Christian Couppé, PhD
role: STUDY_DIRECTOR
affiliation: Institute of Sports Medicine
name: Louis Lepetit Thomsen
role: PRINCIPAL_INVESTIGATOR
References: