Protein Turnover in Healthy and Overuse-diseased Tendon

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05776485
Collaborator
(none)
36
1
2
20
1.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Progressive resistance training
  • Other: Cross-sectional comparison between healthy and tendinopathic group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Protein Turnover in Healthy and Overuse-diseased Tendon
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chronic tendinopathy patients

Other: Cross-sectional comparison between healthy and tendinopathic group
Comparison of primary and secondary outcomes.

Experimental: Healthy controls

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

Other: Cross-sectional comparison between healthy and tendinopathic group
Comparison of primary and secondary outcomes.

Outcome Measures

Primary Outcome Measures

  1. Protein turnover in tendon tissue from patients with chronic tendinopathy compared to healthy controls [8 days]

    Fractional synthesis rate (FSR) measured in % pr. day in the trypsin-soluble and trypsin-insoluble fraction

Secondary Outcome Measures

  1. Tracer incorporation in isolated fractions of the tendon [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 [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 [8 days]

    Measured in millimeter

  4. Doppler flow in patella tendon [8 days]

    Classified in grading system from 0-3.

  5. Subjective pain in patella tendon [8 days]

    Questionnaire

  6. Subjective measure of physical activity and function [1 day]

    Questionnaire

  7. Single-leg decline squat test [1 day]

    Subjective pain on a scale from 0-10

  8. One leg knee extension strength test [8 days]

    Only control-group.

  9. Leg press strength test [8 days]

    Only control-group.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Sports Medicine Copenhagen Copenhagen Capital Region Denmark 2400

Sponsors and Collaborators

  • Bispebjerg Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ann Damgaard, Medical Doctor, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT05776485
Other Study ID Numbers:
  • Project 159
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 20, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 20, 2023