Protein Turnover in Healthy and Overuse-diseased Tendon

Not Applicable

Completed

• Conditions: Patella; Tendinitis
• Interventions: Other: Cross-sectional comparison between healthy and tendinopathic group; Other: Progressive resistance training

• Registration Number: NCT05776485
• Lead Sponsor: Bispebjerg Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-17
• Study First Posted: 2023-03-20
• Study Start: 2023-05-10
• Status Verified: 2024-05
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronic tendinopathy patients	Cross-sectional comparison between healthy and tendinopathic group	-
Healthy controls	Cross-sectional comparison between healthy and tendinopathic group	-
Healthy controls	Progressive resistance training	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Leg press strength test	8 days	Only control-group.
Doppler flow in patella tendon	8 days	Classified in grading system from 0-3.
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
Anterior-posterior dimensions of patella tendon	8 days	Measured in millimeter
Subjective pain in patella tendon	8 days	Questionnaire
Single-leg decline squat test	1 day	Subjective pain on a scale from 0-10
Subjective measure of physical activity and function	1 day	Questionnaire
One leg knee extension strength test	8 days	Only control-group.

Trial Locations

Locations (1)

Institute of Sports Medicine Copenhagen; 🇩🇰 Copenhagen, Capital Region, Denmark