Effect of Collagen Supplementation on Tendinopathy

Not Applicable

Active, not recruiting

• Conditions: Tendinopathy
• Interventions: Dietary Supplement: Hydrolyzed collagen; Dietary Supplement: Placebo; Other: Heavy slow resistance training

• Registration Number: NCT04578418
• Lead Sponsor: Bispebjerg Hospital

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 Timeline

• Study First Submitted: 2020-09-15
• Study Start: 2020-09-16
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2025-01-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen + heavy slow resistance group	Hydrolyzed collagen	Daily collagen supplementation + heavy slow resistance training three times weekly for 12 weeks.
Placebo + heavy slow resistance group	Placebo	Daily placebo supplementation + heavy slow resistance training three times weekly for 12 weeks.
Collagen + heavy slow resistance group	Heavy slow resistance training	Daily collagen supplementation + heavy slow resistance training three times weekly for 12 weeks.
Placebo + heavy slow resistance group	Heavy slow resistance training	Daily placebo supplementation + heavy slow resistance training three times weekly for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 (dichotomal : 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 (dichotomal : 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 (dichotomal : 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 the program 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

Trial Locations

Locations (1)

Department of Physical and Occupational Therapy/Institute of Sports Medicine Copenhagen, Bispebjerg Hospital; 🇩🇰 Copenhagen NV, Denmark