Back to resultsProtein Turnover in Healthy and Overuse-diseased Tendon
Primary Purpose
Patella; Tendinitis
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Progressive resistance training
Cross-sectional comparison between healthy and tendinopathic group
Sponsored by
About this trial
This is an interventional basic science trial for Patella; Tendinitis
Eligibility Criteria
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.
Sites / Locations
- Institute of Sports Medicine CopenhagenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Chronic tendinopathy patients
Healthy controls
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Tracer incorporation in isolated fractions of the tendon
15N hydroxyproline enrichment measured in Mole percent Excess in the trypsin-soluble and trypsin-insoluble fraction
Tracer incorporation in isolated fractions of the tendon
15N proline enrichment measured in Mole percent Excess in the trypsin-soluble and trypsin-insoluble fraction
Anterior-posterior dimensions of patella tendon
Measured in millimeter
Doppler flow in patella tendon
Classified in grading system from 0-3.
Subjective pain in patella tendon
Questionnaire
Subjective measure of physical activity and function
Questionnaire
Single-leg decline squat test
Subjective pain on a scale from 0-10
One leg knee extension strength test
Only control-group.
Leg press strength test
Only control-group.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05776485
Brief Title
Protein Turnover in Healthy and Overuse-diseased Tendon
Official Title
Protein Turnover in Healthy and Overuse-diseased Tendon
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patella; Tendinitis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chronic tendinopathy patients
Arm Type
Experimental
Arm Title
Healthy controls
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Progressive resistance training
Intervention Description
Only the control group: 3 exercise bouts within the study period. Comparison between exercised and non-exercised leg.
Intervention Type
Other
Intervention Name(s)
Cross-sectional comparison between healthy and tendinopathic group
Intervention Description
Comparison of primary and secondary outcomes.
Primary Outcome Measure Information:
Title
Protein turnover in tendon tissue from patients with chronic tendinopathy compared to healthy controls
Description
Fractional synthesis rate (FSR) measured in % pr. day in the trypsin-soluble and trypsin-insoluble fraction
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Tracer incorporation in isolated fractions of the tendon
Description
15N hydroxyproline enrichment measured in Mole percent Excess in the trypsin-soluble and trypsin-insoluble fraction
Time Frame
8 days
Title
Tracer incorporation in isolated fractions of the tendon
Description
15N proline enrichment measured in Mole percent Excess in the trypsin-soluble and trypsin-insoluble fraction
Time Frame
8 days
Title
Anterior-posterior dimensions of patella tendon
Description
Measured in millimeter
Time Frame
8 days
Title
Doppler flow in patella tendon
Description
Classified in grading system from 0-3.
Time Frame
8 days
Title
Subjective pain in patella tendon
Description
Questionnaire
Time Frame
8 days
Title
Subjective measure of physical activity and function
Description
Questionnaire
Time Frame
1 day
Title
Single-leg decline squat test
Description
Subjective pain on a scale from 0-10
Time Frame
1 day
Title
One leg knee extension strength test
Description
Only control-group.
Time Frame
8 days
Title
Leg press strength test
Description
Only control-group.
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Damgaard
Phone
004522278320
Email
ann.damgaard.02@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kjær, Professor
Organizational Affiliation
Institute of Sports Medicine, Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Sports Medicine Copenhagen
City
Copenhagen
State/Province
Capital Region
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Damgaard
Phone
004522278320
Email
ann.damgaard.02@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared with other researchers upon request.
Learn more about this trial
Protein Turnover in Healthy and Overuse-diseased Tendon
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