Effect of Collagen Supplementation on Tendinopathy

NCT ID: NCT04578418

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2025-05-01

Brief Summary

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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

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

Conditions

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Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Collagen + heavy slow resistance group

Daily collagen supplementation + heavy slow resistance training three times weekly for 12 weeks.

Group Type ACTIVE_COMPARATOR

Hydrolyzed collagen

Intervention Type DIETARY_SUPPLEMENT

Hydrolyzed collagen supplementation twice daily

Heavy slow resistance training

Intervention Type OTHER

Heavy slow resistance training 3 times weekly

Placebo + heavy slow resistance group

Daily placebo supplementation + heavy slow resistance training three times weekly for 12 weeks.

Group Type EXPERIMENTAL

Heavy slow resistance training

Intervention Type OTHER

Heavy slow resistance training 3 times weekly

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo supplementation twice daily

Interventions

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Hydrolyzed collagen

Hydrolyzed collagen supplementation twice daily

Intervention Type DIETARY_SUPPLEMENT

Heavy slow resistance training

Heavy slow resistance training 3 times weekly

Intervention Type OTHER

Placebo

Placebo supplementation twice daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Team Denmark

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christian Couppé

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Couppé, PhD

Role: STUDY_DIRECTOR

Institute of Sports Medicine

Louis Lepetit Thomsen

Role: PRINCIPAL_INVESTIGATOR

Institute of Sports Medicine

Locations

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

Copenhagen NV, , Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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H-16019857

Identifier Type: -

Identifier Source: org_study_id

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