Protein Turnover in Healthy and Overuse-diseased Tendon

May 31, 2024 updated by: Ann Damgaard, Bispebjerg Hospital
The goal of this clinical trial is to examine the regional protein turnover in tendon tissue from patients with chronic patellar tendinopathy and comparing this to healthy controls. Further we will examine the effect of resistance training on protein turnover in healthy individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2400
        • Institute of Sports Medicine Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Physical active men and women
  • Body mass index 18,5 - 30 kg/m2

Inclusion Criteria for the chronic tendinopathy group:

  • Debut of symptom > 90 days prior to inclusion.
  • Subjective activity related pain in patella tendon.
  • Clinical symptoms of patella tendinopathy.
  • Ultrasound verification of at least 1 in three of the following: Enchanced anterior-posterior diameter, increased Doppler signal and/or a hypoechoic area in the diseased part of the tendon.

Exclusion Criteria for all participants:

  • Former knee surgery or injuries to the patella tendon.
  • Local injection of corticosteroids within 12 months.
  • Medication that affects protein synthesis in tendon tissue.
  • Former/current use of anabolic steroids or growth hormone.
  • Smoking
  • Known rheumatoid disease or diabetes.
  • Former participation in trials using deuterated water and 15N tracers.
  • Treatment for patella tendinopathy within 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy controls
Other: Cross-sectional comparison between healthy and tendinopathic group
Comparison of primary and secondary outcomes.
Other: Progressive resistance training
Only the control group: 3 exercise bouts within the study period. Comparison between exercised and non-exercised leg.
Experimental: Chronic tendinopathy patients
Other: Cross-sectional comparison between healthy and tendinopathic group
Comparison of primary and secondary outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protein turnover in tendon tissue from patients with chronic tendinopathy compared to healthy controls
Time Frame: 8 days
Fractional synthesis rate (FSR) measured in % pr. day in the trypsin-soluble and trypsin-insoluble fraction
8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tracer incorporation in isolated fractions of the tendon
Time Frame: 8 days
15N hydroxyproline enrichment measured in Mole percent Excess in the trypsin-soluble and trypsin-insoluble fraction
8 days
Tracer incorporation in isolated fractions of the tendon
Time Frame: 8 days
15N proline enrichment measured in Mole percent Excess in the trypsin-soluble and trypsin-insoluble fraction
8 days
Anterior-posterior dimensions of patella tendon
Time Frame: 8 days
Measured in millimeter
8 days
Doppler flow in patella tendon
Time Frame: 8 days
Classified in grading system from 0-3.
8 days
Subjective pain in patella tendon
Time Frame: 8 days
Questionnaire
8 days
Subjective measure of physical activity and function
Time Frame: 1 day
Questionnaire
1 day
Single-leg decline squat test
Time Frame: 1 day
Subjective pain on a scale from 0-10
1 day
One leg knee extension strength test
Time Frame: 8 days
Only control-group.
8 days
Leg press strength test
Time Frame: 8 days
Only control-group.
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Michael Kjær, Professor, Institute of Sports Medicine, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project 159

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared with other researchers upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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