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Effect of Collagen Supplementation on Tendinopathy

Primary Purpose

Tendinopathy

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Hydrolyzed collagen
Heavy slow resistance training
Placebo
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy

Eligibility Criteria

18 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Collagen + heavy slow resistance group

Placebo + heavy slow resistance group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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
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)
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)
Treatment satisfaction
Participants will be asked after the intervention period whether they were satisfied or not with the treatment (dichotom : Yes vs. No)
Collagen supplement
Participants will be asked on a weekly basis if taken their collagen supplement : Questionnaire (dichotom : Yes vs. No)
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
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)
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
Change from baseline Foot function index - Plantaris questionnaire at 12 wks
Patient reported outcome regarding symptoms, function and the ability to participate in sports
Tendon Doppler activity using Ultrasonography power Doppler
Using Ultrasonography, we will measure Doppler activity within the affected tendon and use ImageJ for the analysis
Tendon thickness measured using Ultrasonography
Pain rating on Numeric Rating Scale (NRS; 0 = no pain; 10 = worst imaginable pain) during training.

Full Information

First Posted
September 15, 2020
Last Updated
January 14, 2021
Sponsor
Bispebjerg Hospital
Collaborators
Team Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04578418
Brief Title
Effect of Collagen Supplementation on Tendinopathy
Official Title
Effect of Collagen Supplementation on Tendinopathy in Elite Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
Team Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Collagen + heavy slow resistance group
Arm Type
Active Comparator
Arm Description
Daily collagen supplementation + heavy slow resistance training three times weekly for 12 weeks.
Arm Title
Placebo + heavy slow resistance group
Arm Type
Experimental
Arm Description
Daily placebo supplementation + heavy slow resistance training three times weekly for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydrolyzed collagen
Intervention Description
Hydrolyzed collagen supplementation twice daily
Intervention Type
Other
Intervention Name(s)
Heavy slow resistance training
Intervention Description
Heavy slow resistance training 3 times weekly
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo supplementation twice daily
Primary Outcome Measure Information:
Title
Maximal tendon pain during the past week at preferred sporting activity
Description
Change from baseline - 12 weeks using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
Time Frame
Baseline-12 weeks
Secondary Outcome Measure Information:
Title
Maximal tendon pain during the past week at preferred sporting activity
Description
Change from baseline - 6 weeks + 1 month follow-up using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
Time Frame
Baseline, 6 weeks + 6 month follow-up
Title
Self-reported activity level of sporting activities (hours/week)
Description
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
Time Frame
Baseline, 6 and 12 weeks + 6 month follow-up
Title
Single-leg decline squat (SLDS) test
Description
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)
Time Frame
Baseline - 12 weeks
Title
Jump test
Description
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)
Time Frame
Baseline - 12 weeks
Title
Treatment satisfaction
Description
Participants will be asked after the intervention period whether they were satisfied or not with the treatment (dichotom : Yes vs. No)
Time Frame
12 weeks
Title
Collagen supplement
Description
Participants will be asked on a weekly basis if taken their collagen supplement : Questionnaire (dichotom : Yes vs. No)
Time Frame
Baseline - 12 weeks + 6 month follow-up
Title
Adverse events (e.g. allergies, gastro-intestinal side effects) related to supplement ingestion
Description
Participants will self-report adverse events during intervention period and at 6 month follow-up
Time Frame
Baseline - 12 weeks + 6 month follow-up
Title
Return-to-sport activities
Description
Participants will self-report Return-to-sport activities during intervention period and at 6 month follow-up (dichotom : Yes vs. No)
Time Frame
Baseline - 12 weeks + 6 month follow-up
Title
Change from baseline Victorian Institute of Sports Assessment - Patella/Achilles Questionnaire (VISA-P/A) at 12 wks
Description
Patient reported outcome regarding symptoms, function and the ability to participate in sports
Time Frame
Baseline, 6 and 12 weeks + 6 month follow-up
Title
Change from baseline Foot function index - Plantaris questionnaire at 12 wks
Description
Patient reported outcome regarding symptoms, function and the ability to participate in sports
Time Frame
Baseline, 6 and 12 weeks + 6 month follow-up
Title
Tendon Doppler activity using Ultrasonography power Doppler
Description
Using Ultrasonography, we will measure Doppler activity within the affected tendon and use ImageJ for the analysis
Time Frame
Baseline - 12 weeks
Title
Tendon thickness measured using Ultrasonography
Time Frame
Baseline - 12 weeks
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kasper Dideriksen, PhD
Phone
+4524251989
Email
kasperjuel@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Couppé, PhD
Phone
+4560660825
Email
christian.couppe@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Couppé, PhD
Organizational Affiliation
Institute of Sports Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kasper Dideriksen, PhD
Organizational Affiliation
Team Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical and Occupational Therapy/Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
City
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Couppé, PhD
Phone
60660825
Email
christian.couppe@regionh.dk
First Name & Middle Initial & Last Name & Degree
Christian Couppé, PhD
First Name & Middle Initial & Last Name & Degree
Kasper Dideriksen, PhD
First Name & Middle Initial & Last Name & Degree
Christoffer Brushøj, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Collagen Supplementation on Tendinopathy

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