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Effect of Collagen Supplementation on Tendinopathy

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ClinicalTrials.gov Identifier: NCT04578418
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Team Denmark
Information provided by (Responsible Party):
Kasper Dideriksen, 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.

Condition or disease Intervention/treatment Phase
Tendinopathy Dietary Supplement: Hydrolyzed collagen Other: Heavy slow resistance training Dietary Supplement: Placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Collagen Supplementation on Tendinopathy in Elite Athletes
Actual Study Start Date : September 16, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis
Drug Information available for: Collagen

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Maximal tendon pain during the past week at preferred sporting activity [ Time Frame: Baseline, 6 weeks + 1 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 + 1 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 and at 1 month follow-up whether they were satisfied or not with the treatment (dichotom : Yes vs. No)

  6. Collagen supplement [ Time Frame: Baseline - 12 weeks + 1 month follow-up ]
    Participants will be asked on a weekly basis if taken their collagen supplement : Questionnaire (dichotom : Yes vs. No)

  7. Adverse events (e.g. allergies, gastro-intestinal side effects) related to supplement ingestion [ Time Frame: Baseline - 12 weeks + 1 month follow-up ]
    Participants will self-report adverse events during intervention period and at 1 month follow-up

  8. Return-to-sport activities [ Time Frame: Baseline - 12 weeks + 1 monthe follow-up ]
    Participants will self-report Return-to-sport activities during intervention period and at 1 month follow-up (dichotom : 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 + 1 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 + 1 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 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 + 1 month follow-up ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578418


Contacts
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Contact: Kasper Dideriksen, PhD +4524251989 kasperjuel@hotmail.com
Contact: Christian Couppé, PhD +4560660825 christian.couppe@regionh.dk

Locations
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Denmark
Department of Physical and Occupational Therapy/Institute of Sports Medicine Copenhagen, Bispebjerg Hospital Recruiting
Copenhagen NV, Denmark, 2400
Contact: Christian Couppé, PhD    60660825    christian.couppe@regionh.dk   
Principal Investigator: Christian Couppé, PhD         
Principal Investigator: Kasper Dideriksen, PhD         
Principal Investigator: Christoffer Brushøj, MD         
Sponsors and Collaborators
Bispebjerg Hospital
Team Denmark
Investigators
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Study Director: Christian Couppé, PhD Institute of Sports Medicine
Principal Investigator: Kasper Dideriksen, PhD Team Denmark
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Responsible Party: Kasper Dideriksen, Principal Investigator, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT04578418    
Other Study ID Numbers: H-16019857
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries