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Active, Not Recruiting

NCT Number: NCT04578418

Effect of Collagen Supplementation on Tendinopathy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical and Occupational Therapy/Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrolyzed collagen

Dietary Supplement

Hydrolyzed collagen supplementation twice daily

Heavy slow resistance training

Other

Heavy slow resistance training 3 times weekly

Placebo

Dietary Supplement

Placebo supplementation twice daily

Primary outcomes

  1. Maximal tendon pain during the past week at preferred sporting activity

    Time frame: Baseline-12 weeks

    Change from baseline - 12 weeks using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)

Secondary outcomes

  1. Maximal tendon pain during the past week at preferred sporting activity

    Time frame: 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)

  2. Self-reported activity level of sporting activities (hours/week)

    Time frame: 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

  3. Single-leg decline squat (SLDS) test

    Time frame: 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)

  4. Jump test

    Time frame: 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)

  5. Treatment satisfaction

    Time frame: 12 weeks

    Participants will be asked after the intervention period whether they were satisfied or not with the treatment (dichotomal : Yes vs. No)

  6. Collagen supplement

    Time frame: 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)

  7. Adverse events (e.g. allergies, gastro-intestinal side effects) related to supplement ingestion

    Time frame: Baseline - 12 weeks + 6 month follow-up

    Participants will self-report adverse events during intervention period and at 6 month follow-up

  8. Return-to-sport activities

    Time frame: 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)

  9. Change from baseline Victorian Institute of Sports Assessment - Patella/Achilles Questionnaire (VISA-P/A) at 12 wks

    Time frame: Baseline, 6 and 12 weeks + 6 month follow-up

    Patient reported outcome regarding symptoms, function and the ability to participate in sports

  10. Change from baseline Foot function index - Plantaris questionnaire at 12 wks

    Time frame: Baseline, 6 and 12 weeks + 6 month follow-up

    Patient reported outcome regarding symptoms, function and the ability to participate in sports

  11. Tendon Doppler activity using Ultrasonography power Doppler

    Time frame: Baseline - 12 weeks

    Using Ultrasonography, we will measure Doppler activity within the affected tendon and use the program ImageJ for the analysis

  12. Tendon thickness measured using Ultrasonography

    Time frame: Baseline - 12 weeks

  13. 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

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Team Denmark
  • University of Aarhus

Registry information

Official study title

Effect of Collagen Supplementation on Tendinopathy in Elite Athletes

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2020
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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