TendinopathyNCT04578418
Effect of Collagen Supplementation on Tendinopathy
A study testing Hydrolyzed collagen and Heavy slow resistance training in people with Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Hydrolyzed collagen and Heavy slow resistance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Sep 2020to 1 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Physical and Occupational Therapy/Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Copenhagen NV, 2400
About this study
Official title: 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.
Read the detailed description
Randomized placebo-controlled intervention study with follow-up after one month
- Conditions
- Tendinopathy
- Being tested
- Hydrolyzed collagen, Heavy slow resistance training, Placebo
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolyzed collagenDietary supplement
Hydrolyzed collagen supplementation twice daily
Heavy slow resistance trainingOther
Heavy slow resistance training 3 times weekly
PlaceboDietary supplement
Placebo supplementation twice daily
| Study group | Role | What they receive |
|---|---|---|
| Collagen + heavy slow resistance group | Active comparator | Daily collagen supplementation + heavy slow resistance training three times weekly for 12 weeks. Receives: Dietary Supplement: Hydrolyzed collagen; Other: Heavy slow resistance training |
| Placebo + heavy slow resistance group | Experimental | Daily placebo supplementation + heavy slow resistance training three times weekly for 12 weeks. Receives: Other: Heavy slow resistance training; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline-12 weeks
Secondary outcomes (13)
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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: Baseline - 12 weeks
Treatment satisfaction
Participants will be asked after the intervention period whether they were satisfied or not with the treatment (dichotomal : Yes vs. No)
Measured: 12 weeks
Collagen supplement
Participants will be asked on a weekly basis if taken their collagen supplement : Questionnaire (dichotomal : Yes vs. No)
Measured: 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
Measured: 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 (dichotomal : Yes vs. No)
Measured: 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
Measured: 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
Measured: 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 the program ImageJ for the analysis
Measured: Baseline - 12 weeks
Tendon thickness measured using Ultrasonography
Measured: Baseline - 12 weeks
Pain rating on Numeric Rating Scale (NRS; 0 = no pain; 10 = worst imaginable pain) during training.
Measured: Baseline, 6 and 12 weeks + 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start16 Sep 2020
- Primary completion1 Jan 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Team Denmark, University of Aarhus
- Responsible party
- Principal investigator, Christian Couppé, Bispebjerg Hospital
- Investigators
- Christian Couppé, PhD, Study director, Institute of Sports MedicineLouis Lepetit Thomsen, Principal investigator, Institute of Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578418
- Sponsor's protocol ID
- H-16019857
- Status last verified
- Nov 2024
- First submitted
- 15 Sep 2020
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Collagen Supplementation on Tendinopathy in Elite Athletes
- ClinicalTrials.gov ID
- NCT04578418
- Acronym / sponsor ID
- H-16019857
- Conditions
- Tendinopathy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Team Denmark, University of Aarhus
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen + heavy slow resistance group | Active comparator | Dietary Supplement: Hydrolyzed collagen, Other: Heavy slow resistance trainingDaily collagen supplementation + heavy slow resistance training three times weekly for 12 weeks. |
| Placebo + heavy slow resistance group | Experimental | Other: Heavy slow resistance training, Dietary Supplement: PlaceboDaily placebo supplementation + heavy slow resistance training three times weekly for 12 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Previous tendon surgery
- Diabetes
- Arthritis
- Corticosteroid injection for tendinopathy within the last 3 months
- Any form of tendon injection within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrolyzed collagenHydrolyzed collagen supplementation twice daily | Dietary supplement | Collagen + heavy slow resistance group |
| Heavy slow resistance trainingHeavy slow resistance training 3 times weekly | Other | Collagen + heavy slow resistance group, Placebo + heavy slow resistance group |
| PlaceboPlacebo supplementation twice daily | Dietary supplement | Placebo + heavy slow resistance group |
Primary outcome
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)
13 secondary outcomes
Maximal tendon pain during the past week at preferred sporting activity
Time frame: Baseline, 6 weeks + 6 month follow-up
Self-reported activity level of sporting activities (hours/week)
Time frame: Baseline, 6 and 12 weeks + 6 month follow-up
Single-leg decline squat (SLDS) test
Time frame: Baseline - 12 weeks
Jump test
Time frame: Baseline - 12 weeks
Treatment satisfaction
Time frame: 12 weeks
Collagen supplement
Time frame: Baseline - 12 weeks + 6 month follow-up
Adverse events (e.g. allergies, gastro-intestinal side effects) related to supplement ingestion
Time frame: Baseline - 12 weeks + 6 month follow-up
Return-to-sport activities
Time frame: Baseline - 12 weeks + 6 month follow-up
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
Change from baseline Foot function index - Plantaris questionnaire at 12 wks
Time frame: Baseline, 6 and 12 weeks + 6 month follow-up
Tendon Doppler activity using Ultrasonography power Doppler
Time frame: Baseline - 12 weeks
Tendon thickness measured using Ultrasonography
Time frame: Baseline - 12 weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Couppé, PhD study director
Institute of Sports Medicine
Louis Lepetit Thomsen principal investigator
Institute of Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolyzed collagen and Heavy slow resistance training in people with Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal tendon pain during the past week at preferred sporting activity (time frame: Baseline-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.