NCT04578418

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 16, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 4, 2024

Status Verified

November 1, 2024

Enrollment Period

4.3 years

First QC Date

September 15, 2020

Last Update Submit

November 1, 2024

Conditions

Tendinopathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Maximal tendon pain during the past week at preferred sporting activity

    Baseline, 6 weeks + 6 month follow-up

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

    Baseline, 6 and 12 weeks + 6 month follow-up

  • Single-leg decline squat (SLDS) test

    Baseline - 12 weeks

  • Jump test

    Baseline - 12 weeks

  • Treatment satisfaction

    12 weeks

  • +8 more secondary outcomes

Study Arms (2)

Collagen + heavy slow resistance group

ACTIVE COMPARATOR

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

Dietary Supplement: Hydrolyzed collagenOther: Heavy slow resistance training

Placebo + heavy slow resistance group

EXPERIMENTAL

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

Other: Heavy slow resistance trainingDietary Supplement: Placebo

Interventions

Hydrolyzed collagenDIETARY_SUPPLEMENT

Hydrolyzed collagen supplementation twice daily

Collagen + heavy slow resistance group
Heavy slow resistance trainingOTHER

Heavy slow resistance training 3 times weekly

Collagen + heavy slow resistance groupPlacebo + heavy slow resistance group
PlaceboDIETARY_SUPPLEMENT

Placebo supplementation twice daily

Placebo + heavy slow resistance group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elite athletes
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Study Officials

  • Christian Couppé, PhD

    Institute of Sports Medicine

    STUDY DIRECTOR

  • Louis Lepetit Thomsen

    Institute of Sports Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2020

First Posted

October 8, 2020

Study Start

September 16, 2020

Primary Completion

January 1, 2025

Study Completion

May 1, 2025

Last Updated

November 4, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)