Patellar TendinopathyTEREXNCT05731037
Influence of Restitution Time in Treatment of Patellar Tendinopathy
A study testing Resistance training for knee extensors in people with Patellar Tendinopathy and Jumper's Knee, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of the present project is to investigate if the restitution time from loading in an exercise-based 12 weeks rehabilitation regime for patellar tendinopathy influences the clinical outcome, tendon structure and function. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Patellar Tendinopathy, Jumper's Knee
- What is being tested?
- Resistance training for knee extensors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Mar 2023to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sports active men and women.
- Age (18-60) years old.
- BMI (18.5-30)
- Understand and read Danish
- Uni- or bilateral patellar tendinopathy
- Symptom onset >90 days ago
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- Five patients from the main study, rating "improved" and "not improved" respectively, will be invited to participate in sub-study one.
- Patients from the main study, that rate themselves 'not improved' in symptoms after 12 week.
- Patients who have not achieved Patient Acceptable Symptom State (PASS) after week 20, 24, 28, 32, 36 and 40, will be invited to participate in sub- study two.
Who cannot join
- Patellar tendinopathy longer than 24 months
- Smoking
- Previous surgery in the knee on the ipsilateral side.
- Corticosteroid injection in the patellar tendon on the ipsilateral side within the last 6 months.
- Any confounding diagnosis to the knee joint
- Known arthritis
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- Known diabetes
- Inability to follow rehabilitation or complete follow-ups
- Enrolled in a resistance based-rehabilitation program for the affected patellar tendon within the previous three month
- Have a work were it is not feasible to avoid pain provoking tasks
- Extra criteria sub-study one
- Claustrophobia
- Pregnancy
- Breastfeeding
- Extra criteria sub-study two:
- Pregnancy
- Breastfeeding
- Previously had an allergic reaction for steroid (Depomedrol).
- Previously had an allergic reaction for local anesthesia treatment.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Physical & Occupational Therapy/ Institute of Sports Medicine, Bispebjerg Hospital
Copenhagen, NV, 2400
About this study
Official title: Patellar Tendinopathy - The Role of Restitution Time in Exercise- Based Treatment: A Randomized Controlled Trial (the TEREX Trial)
The purpose of the present project is to investigate if the restitution time from loading in an exercise-based 12 weeks rehabilitation regime for patellar tendinopathy influences the clinical outcome, tendon structure and function.
The investigators hypothesize that greater restitution from loading (1 exercise day per week) will yield a greater positive clinical outcome, and tissue structure and function in patients with patellar tendinopathy compared to less restitution (3 exercise days per week), when impact activities are restricted in both groups.
Read the detailed description
This study is designed as a prospective, randomized, controlled, open label, superiority trial with a two-group parallel design and primary endpoint after 12 weeks. The study has two phases; The first phase includes the main trial in which a 12-week intervention period will be undertaken to test the hypotheses in patients with chronic patellar tendinopathy (symptoms > 3 months).
At 12 weeks, a smaller group of patients (responding and not-responding to the 12-week intervention period) will be offered to participate in sub-study 1. In this explorative cross-sectional study, the feasibility of mapping brain structure, function and metabolism using Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique in chronic patellar tendinopathy patients will be assessed.
The second phase in the main study includes the follow-up from 12 week to the secondary endpoint at 52 weeks after baseline. During this period the participants will be monitored via questionnaires for treatment satisfaction and improvements at 4-week intervals. What treatment and the duration of treatment patients will receive in this phase is based on the concept of personalized medicine. We expect the majority of patient to continue in the group with loading-based intervention. A smaller group of the 52 patients from the main study is expected to be included in sub-study two.
Sub study two is designed as an observational cohort study. In this sub study, patients reporting no self-evaluated improvement after 12 weeks of loading-based treatment will be asked to be part of a group receiving corticosteroid injection treatment followed by continued exercise-based treatment and avoidance of impact loading. The cohort will further include patients that after week 20, 24, 28, 32, 36 and 40 respond that they have not achieved their Patient Acceptable Symptom State (PASS).
- Conditions
- Patellar Tendinopathy, Jumper's Knee
- Being tested
- Resistance training for knee extensors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance training for knee extensorsOther
The exercise will be started at 60% of 1 repetition maximum (RM) and progressed to 75% of 1 RM during the first 3 weeks and maintained throughout the intervention period. The exercise will be performed slowly (6 s/ repetition).
| Study group | Role | What they receive |
|---|---|---|
| Short restitution group (SR) | Active comparator | Resistance training for knee extensors three training session per week. Receives: Other: Resistance training for knee extensors |
| Extended restitution group (ER) | Experimental | Resistance training for knee extensors on training session per week (greater restitution from loading). Receives: Other: Resistance training for knee extensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient perception VISA-P
Change in Victorian Institute of Sports Assessment - patella (VISA-P) total score. The VISA-P asses symptoms, function and the ability to participate in sport. It consists of 8 questions, with a maximum score of 100 indicating the person is asymptomatic and fully per-forming and lower scores indicating more symptoms and limitations of function and activity.
Measured: Change from baseline at week 12
Secondary outcomes (18)
Patient perception VISA-P secondary
Change in Victorian Institute of Sports Assessment - patella (VISA-P) total score. The VISA-P asses symptoms, function and the ability to participate in sport. It consists of 8 questions, with a maximum score of 100 indicating the person is asymptomatic and fully per-forming and lower scores indicating more symptoms and limitations of function and activity.
Measured: Change from baseline at week 16 and 52
Patient perception VISA-P truncated
Change in Victorian Institute of Sports Assessment - patella (VISA-P) truncated score. The truncated score only including questions 2-6, with a maximum score of 50. Lower scores indicating more symptoms and limitations of function and activity.
Measured: Change from baseline at week 12, 16 and 52
Self-reported pain (NRS) - Preferred sport
Change in pain rating on an 11 point numeric rating scale (NRS) during preferred sport, with 10 being the worst imaginable pain and 0 denoting no pain.
Measured: Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Self-reported pain (NRS) - Rest
Change in pain rating on an 11 point numeric rating scale (NRS) during rest, with 10 being the worst imaginable pain and 0 denoting no pain.
Measured: Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Self-reported pain (NRS) - Daily activities
Change in pain rating on an 11 point numeric rating scale (NRS) during daily activities, with 10 being the worst imaginable pain and 0 denoting no pain.
Measured: Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Self-reported improvement (GROC)
Self-reported improvement after treatment will be evaluated by the Global Rating of change (GROC) on a 7-point Likert scale ranging from 'much improved' to 'much worse'.
Measured: Change from baseline at week 12, 16 and 52.
Sports participation
Number of sports participation hours per week (training and competition).
Measured: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Sports types
Typer of sports performed.
Measured: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Sports intensity
Intensity of sport performed registred in a self-reported questianaire and categorized as; light, moderate or vigorous.
Measured: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Self-reported satisfaction (PASS)
Self-evaluated satisfaction with treatment result will be evaluated by Patient Acceptable Symptom State (PASS) on a 5-point Likert scale ranging from 'very satisfied' to 'very unsaticfied'
Measured: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Treatment received
Registration of any additive treatment received from last follow-up measured with self-reported questionnaire.
Measured: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Care-seeking behavior
Registration of any additive care-seeking behavior from last follow-up measured with self-reported questionnaire.
Measured: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
The single-leg decline squat (SLDS) will be used to assess pain during function
Participants performed a decline squat on a 25°decline board and reported pain using an 11 point numeric rating scale (NRS) upon completion, with 10 being the worst imaginable pain and 0 denoting no pain.
Measured: Change from baseline at week 12 and 52.
Muscle strength
Maximal muscle strength is obtained during standardized maximal voluntary contractions.
Measured: Change from baseline at week 12 and 52.
Ultrasonography - tendon thickness
Grey scale ultrasonography will be used for evaluation of patellar tendon thickness.
Measured: Change from baseline at week 12 and 52.
Ultrasonography - tendon neovascularization
Doppler ultrasonography will be used for evaluation of patellar tendon neovascularization.
Measured: Change from baseline at week 12 and 52.
Ultrasonography - tendon microvascularisation
B-Flow ultrasonography will be used for evaluation of patellar tendon microvascularisation.
Measured: Change from baseline at week 12 and 52.
Counter movement Jump height
Jump height during Counter movement Jump test will be used to assess patellar tendinopathy caused functional deficits.
Measured: Change from baseline at week 12 and 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start2 Mar 2023
- Primary completion10 Feb 2025 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar TendinopathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Sofie Agergaard, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731037
- Sponsor's protocol ID
- The TEREX trial
- Acronym
- TEREX
- Status last verified
- Sep 2024
- First submitted
- 27 Jan 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patellar Tendinopathy - The Role of Restitution Time in Exercise- Based Treatment: A Randomized Controlled Trial (the TEREX Trial)
- ClinicalTrials.gov ID
- NCT05731037
- Acronym / sponsor ID
- TEREX / The TEREX trial
- Conditions
- Patellar Tendinopathy, Jumper's Knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 10 Feb 2025 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 16 Feb 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 purpose of the present project is to investigate if the restitution time from loading in an exercise-based 12 weeks rehabilitation regime for patellar tendinopathy influences the clinical outcome, tendon structure and function.
The investigators hypothesize that greater restitution from loading (1 exercise day per week) will yield a greater positive clinical outcome, and tissue structure and function in patients with patellar tendinopathy compared to less restitution (3 exercise days per week), when impact activities are restricted in both groups.
Detailed description
This study is designed as a prospective, randomized, controlled, open label, superiority trial with a two-group parallel design and primary endpoint after 12 weeks. The study has two phases; The first phase includes the main trial in which a 12-week intervention period will be undertaken to test the hypotheses in patients with chronic patellar tendinopathy (symptoms > 3 months).
At 12 weeks, a smaller group of patients (responding and not-responding to the 12-week intervention period) will be offered to participate in sub-study 1. In this explorative cross-sectional study, the feasibility of mapping brain structure, function and metabolism using Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique in chronic patellar tendinopathy patients will be assessed.
The second phase in the main study includes the follow-up from 12 week to the secondary endpoint at 52 weeks after baseline. During this period the participants will be monitored via questionnaires for treatment satisfaction and improvements at 4-week intervals. What treatment and the duration of treatment patients will receive in this phase is based on the concept of personalized medicine. We expect the majority of patient to continue in the group with loading-based intervention. A smaller group of the 52 patients from the main study is expected to be included in sub-study two.
Sub study two is designed as an observational cohort study. In this sub study, patients reporting no self-evaluated improvement after 12 weeks of loading-based treatment will be asked to be part of a group receiving corticosteroid injection treatment followed by continued exercise-based treatment and avoidance of impact loading. The cohort will further include patients that after week 20, 24, 28, 32, 36 and 40 respond that they have not achieved their Patient Acceptable Symptom State (PASS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short restitution group (SR) | Active comparator | Other: Resistance training for knee extensorsResistance training for knee extensors three training session per week. |
| Extended restitution group (ER) | Experimental | Other: Resistance training for knee extensorsResistance training for knee extensors on training session per week (greater restitution from loading). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Sports active men and women.
- Age (18-60) years old.
- BMI (18.5-30)
- Understand and read Danish
- Uni- or bilateral patellar tendinopathy
Key exclusion criteria (19 listed)
- Patellar tendinopathy longer than 24 months
- Smoking
- Previous surgery in the knee on the ipsilateral side.
- Corticosteroid injection in the patellar tendon on the ipsilateral side within the last 6 months.
- Any confounding diagnosis to the knee joint
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 |
|---|---|---|
| Resistance training for knee extensorsThe exercise will be started at 60% of 1 repetition maximum (RM) and progressed to 75% of 1 RM during the first 3 weeks and maintained throughout the intervention period. The exercise will be performed slowly (6 s/ repetition). | Other | Extended restitution group (ER), Short restitution group (SR) |
Primary outcome
Patient perception VISA-P
Time frame: Change from baseline at week 12
Change in Victorian Institute of Sports Assessment - patella (VISA-P) total score. The VISA-P asses symptoms, function and the ability to participate in sport. It consists of 8 questions, with a maximum score of 100 indicating the person is asymptomatic and fully per-forming and lower scores indicating more symptoms and limitations of function and activity.
18 secondary outcomes
Patient perception VISA-P secondary
Time frame: Change from baseline at week 16 and 52
Patient perception VISA-P truncated
Time frame: Change from baseline at week 12, 16 and 52
Self-reported pain (NRS) - Preferred sport
Time frame: Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Self-reported pain (NRS) - Rest
Time frame: Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Self-reported pain (NRS) - Daily activities
Time frame: Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Self-reported improvement (GROC)
Time frame: Change from baseline at week 12, 16 and 52.
Sports participation
Time frame: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Sports types
Time frame: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Sports intensity
Time frame: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Self-reported satisfaction (PASS)
Time frame: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Treatment received
Time frame: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
Care-seeking behavior
Time frame: Week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.
The single-leg decline squat (SLDS) will be used to assess pain during function
Time frame: Change from baseline at week 12 and 52.
Muscle strength
Time frame: Change from baseline at week 12 and 52.
Ultrasonography - tendon thickness
Time frame: Change from baseline at week 12 and 52.
Ultrasonography - tendon neovascularization
Time frame: Change from baseline at week 12 and 52.
Ultrasonography - tendon microvascularisation
Time frame: Change from baseline at week 12 and 52.
Counter movement Jump height
Time frame: Change from baseline at week 12 and 52.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training for knee extensors in people with Patellar Tendinopathy and Jumper's Knee, 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 9 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient perception VISA-P (time frame: Change from baseline at week 12). 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 1 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.