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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04578418
Other study ID # H-16019857
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 16, 2020
Est. completion date June 1, 2023

Study information

Verified date January 2021
Source Bispebjerg Hospital
Contact Kasper Dideriksen, PhD
Phone +4524251989
Email kasperjuel@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date June 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Hydrolyzed collagen
Hydrolyzed collagen supplementation twice daily
Other:
Heavy slow resistance training
Heavy slow resistance training 3 times weekly
Dietary Supplement:
Placebo
Placebo supplementation twice daily

Locations

Country Name City State
Denmark Department of Physical and Occupational Therapy/Institute of Sports Medicine Copenhagen, Bispebjerg Hospital Copenhagen NV

Sponsors (2)

Lead Sponsor Collaborator
Bispebjerg Hospital Team Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Tendon thickness measured using Ultrasonography Baseline - 12 weeks
Secondary 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
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