Skip to main content
OpenTrials
Completed

NCT Number: NCT05776485

Protein Turnover in Healthy and Overuse-diseased Tendon

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patella; Tendinitis Fractures, Bone Knee Fractures Muscular Diseases Musculoskeletal Diseases Patella Fracture Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sports Medicine Copenhagen

Copenhagen, Capital Region, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Progressive resistance training

Other

Only the control group: 3 exercise bouts within the study period. Comparison between exercised and non-exercised leg.

Cross-sectional comparison between healthy and tendinopathic group

Other

Comparison of primary and secondary outcomes.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Anterior-posterior dimensions of patella tendon

    Time frame: 8 days

    Measured in millimeter

  4. Doppler flow in patella tendon

    Time frame: 8 days

    Classified in grading system from 0-3.

  5. Subjective pain in patella tendon

    Time frame: 8 days

    Questionnaire

  6. Subjective measure of physical activity and function

    Time frame: 1 day

    Questionnaire

  7. Single-leg decline squat test

    Time frame: 1 day

    Subjective pain on a scale from 0-10

  8. One leg knee extension strength test

    Time frame: 8 days

    Only control-group.

  9. Leg press strength test

    Time frame: 8 days

    Only control-group.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2023
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.