Protein Turnover in Healthy and Overuse-diseased Tendon

Patella; Tendinitis Clinical Trial

Official title:

Protein Turnover in Healthy and Overuse-diseased Tendon

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776485
• Other study ID #: Project 159
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2023
• Source: Bispebjerg Hospital
• Contact: Ann Damgaard
• Phone: 004522278320
• Email: ann.damgaard.02[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patella; Tendinitis
• Tendinopathy

Intervention

Other:
• Progressive resistance training
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
Comparison of primary and secondary outcomes.

Locations

Country	Name	City	State
Denmark	Institute of Sports Medicine Copenhagen	Copenhagen	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein turnover in tendon tissue from patients with chronic tendinopathy compared to healthy controls	Fractional synthesis rate (FSR) measured in % pr. day in the trypsin-soluble and trypsin-insoluble fraction	8 days
Secondary	Tracer incorporation in isolated fractions of the tendon	15N hydroxyproline enrichment measured in Mole percent Excess in the trypsin-soluble and trypsin-insoluble fraction	8 days
Secondary	Tracer incorporation in isolated fractions of the tendon	15N proline enrichment measured in Mole percent Excess in the trypsin-soluble and trypsin-insoluble fraction	8 days
Secondary	Anterior-posterior dimensions of patella tendon	Measured in millimeter	8 days
Secondary	Doppler flow in patella tendon	Classified in grading system from 0-3.	8 days
Secondary	Subjective pain in patella tendon	Questionnaire	8 days
Secondary	Subjective measure of physical activity and function	Questionnaire	1 day
Secondary	Single-leg decline squat test	Subjective pain on a scale from 0-10	1 day
Secondary	One leg knee extension strength test	Only control-group.	8 days
Secondary	Leg press strength test	Only control-group.	8 days