Patella; TendinitisNCT05776485
Protein Turnover in Healthy and Overuse-diseased Tendon
A study testing Progressive resistance training and Cross-sectional comparison between healthy and tendinopathic group in people with Patella; Tendinitis, run by Bispebjerg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Patella; Tendinitis
- What is being tested?
- Progressive resistance training and Cross-sectional comparison between healthy and tendinopathic group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 10 May 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physical active men and women
- Body mass index 18,5 - 30 kg/m2
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine Copenhagen
Copenhagen, Capital Region, 2400
About this study
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.
- Conditions
- Patella; Tendinitis
- Being tested
- Progressive resistance training, Cross-sectional comparison between healthy and tendinopathic group
- Medical subject headings
- Patella Fracture, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance trainingOther
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 groupOther
Comparison of primary and secondary outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Chronic tendinopathy patients | Experimental | Not described Receives: Other: Cross-sectional comparison between healthy and tendinopathic group |
| Healthy controls | Experimental | Not described Receives: Other: Progressive resistance training; Other: Cross-sectional comparison between healthy and tendinopathic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 days
Secondary outcomes (9)
Tracer incorporation in isolated fractions of the tendon
15N hydroxyproline enrichment measured in Mole percent Excess in the trypsin-soluble and trypsin-insoluble fraction
Measured: 8 days
Tracer incorporation in isolated fractions of the tendon
15N proline enrichment measured in Mole percent Excess in the trypsin-soluble and trypsin-insoluble fraction
Measured: 8 days
Anterior-posterior dimensions of patella tendon
Measured in millimeter
Measured: 8 days
Doppler flow in patella tendon
Classified in grading system from 0-3.
Measured: 8 days
Subjective pain in patella tendon
Questionnaire
Measured: 8 days
Subjective measure of physical activity and function
Questionnaire
Measured: 1 day
Single-leg decline squat test
Subjective pain on a scale from 0-10
Measured: 1 day
One leg knee extension strength test
Only control-group.
Measured: 8 days
Leg press strength test
Only control-group.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start10 May 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patella; TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Damgaard, Bispebjerg Hospital
- Investigators
- Michael Kjær, Professor, Principal investigator, Institute of Sports Medicine, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776485
- Sponsor's protocol ID
- Project 159
- Status last verified
- May 2024
- First submitted
- 3 Mar 2023
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared with other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Turnover in Healthy and Overuse-diseased Tendon
- ClinicalTrials.gov ID
- NCT05776485
- Acronym / sponsor ID
- Project 159
- Conditions
- Patella; Tendinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic tendinopathy patients | Experimental | Other: Cross-sectional comparison between healthy and tendinopathic group |
| Healthy controls | Experimental | Other: Progressive resistance training, Other: Cross-sectional comparison between healthy and tendinopathic group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Physical active men and women
- Body mass index 18,5 - 30 kg/m2
- Debut of symptom > 90 days prior to inclusion.
- Subjective activity related pain in patella tendon.
- Clinical symptoms of patella tendinopathy.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive resistance trainingOnly the control group: 3 exercise bouts within the study period. Comparison between exercised and non-exercised leg. | Other | Healthy controls |
| Cross-sectional comparison between healthy and tendinopathic groupComparison of primary and secondary outcomes. | Other | Chronic tendinopathy patients, Healthy controls |
Primary outcome
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
9 secondary outcomes
Tracer incorporation in isolated fractions of the tendon
Time frame: 8 days
Tracer incorporation in isolated fractions of the tendon
Time frame: 8 days
Anterior-posterior dimensions of patella tendon
Time frame: 8 days
Doppler flow in patella tendon
Time frame: 8 days
Subjective pain in patella tendon
Time frame: 8 days
Subjective measure of physical activity and function
Time frame: 1 day
Single-leg decline squat test
Time frame: 1 day
One leg knee extension strength test
Time frame: 8 days
Leg press strength test
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No. Data will be shared with other researchers upon request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kjær, Professor principal investigator
Institute of Sports Medicine, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resistance training and Cross-sectional comparison between healthy and tendinopathic group in people with Patella; Tendinitis, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein turnover in tendon tissue from patients with chronic tendinopathy compared to healthy controls (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.