Effect of Collagen Supplementation on Tendinopathy

Effect of Collagen Supplementation on Tendinopathy in Elite Athletes

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.

Study Overview

• Status: Recruiting
• Conditions: Tendinopathy
• Intervention / Treatment: Dietary supplement: Hydrolyzed collagen; Other: Heavy slow resistance training; Dietary supplement: Placebo

Detailed Description

Randomized placebo-controlled intervention study with follow-up after one month

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kasper Dideriksen, PhD; Phone Number: +4524251989; Email: kasperjuel@hotmail.com
• Study Contact Backup: Name: Christian Couppé, PhD; Phone Number: +4560660825; Email: christian.couppe@regionh.dk

Study Locations

• Denmark
  • Copenhagen NV, Denmark, 2400
    • Recruiting
    • Department of Physical and Occupational Therapy/Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
    • Contact: Christian Couppé, PhD; Phone Number: 60660825; Email: christian.couppe@regionh.dk
    • Principal Investigator: Christian Couppé, PhD
    • Principal Investigator: Kasper Dideriksen, PhD
    • Principal Investigator: Christoffer Brushøj, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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)	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)	Baseline - 12 weeks
Treatment satisfaction	Participants will be asked after the intervention period whether they were satisfied or not with the treatment (dichotom : Yes vs. No)	12 weeks
Collagen supplement	Participants will be asked on a weekly basis if taken their collagen supplement : Questionnaire (dichotom : Yes vs. No)	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	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 (dichotom : Yes vs. No)	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	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	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 ImageJ for the analysis	Baseline - 12 weeks
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

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: Team Denmark
• Investigators: Study Director: Christian Couppé, PhD, Institute of Sports Medicine; Principal Investigator: Kasper Dideriksen, PhD, Team Denmark

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: H-16019857

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No