Patellar TendinopathyNCT03096067
Patellar Tendinopathy - The Effect of Load Magnitude in Exercise-based Treatment
A study testing Heavy slow resistance training and Moderate slow resistance training in people with Patellar Tendinopathy and Jumper's Knee, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of this project is to investigate if the magnitude of a loading based 12 weeks rehabilitation regime for patellar tendinopathy influence the clinical outcome, tendon structure and function. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Patellar Tendinopathy, Jumper's Knee
- What is being tested?
- Heavy slow resistance training and Moderate slow resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Mar 2017to 1 Oct 2021
- 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 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Uni- or bilateral patellar tendinopathy
- Symptoms > 3 months
- Ultrasonographical tendon swelling
- Ultrasonographical hypo-echoic area with doppler
- BMI 18.5-30
Who cannot join
- Patellar tendinopathy > 12 month
- Previous knee surgery
- Confounding diagnosis to the knee joint
- Diabetes or arthritis
- Previous corticosteroid injection for patellar tendinopathy
- Smoking
- Being elite volleyball players
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Copenhagen, 2400
About this study
Official title: Treatment of Patellar Tendinopathy; Influence of Load Magnitude on Clinical Outcome, Tendon Structure and Function
The purpose of this project is to investigate if the magnitude of a loading based 12 weeks rehabilitation regime for patellar tendinopathy influence the clinical outcome, tendon structure and function.
The investigators hypothesize that a greater magnitude (90% of 1RM) of loading will yield a more positive clinical outcome, tendon structure and function in patients with patellar tendinopathy compared to a lower magnitude of loading (55% of 1 RM) when total exercise volume is equal in both groups.
Read the detailed description
Randomized controlled intervention study with one year follow-up
- Conditions
- Patellar Tendinopathy, Jumper's Knee
- Being tested
- Heavy slow resistance training, Moderate slow resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy slow resistance trainingOther
Resistance training for knee extensors. The exercise will be performed at 90% of 1 RM and slowly (6 s/repetition).
Moderate slow resistance trainingOther
Resistance training for knee extensors. The exercise will be performed at 55% of 1 RM and slowly (6 s/repetition).
| Study group | Role | What they receive |
|---|---|---|
| Heavy slow resistance group | Active comparator | Heavy slow resistance training. Three times weekly for 12 weeks. Receives: Other: Heavy slow resistance training |
| Moderate slow resistance group | Experimental | Moderate slow resistance training. Three times weekly for 12 weeks. Receives: Other: Moderate slow resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P) at 12 wks
Patient reported outcome regarding symptoms, function and the ability to participate in sports
Measured: 0-12 wks
Secondary outcomes (9)
Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P)
Patient reported outcome regarding symptoms, function and the ability to
Measured: 0 and 6 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
Pain rating on numeric rating scale (NRS) and activity level of sporting activities (h/wk)
Questionnaire
Measured: 0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
Tendon thickness and Doppler activity
Measured by ultrasound
Measured: 0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
Single-leg decline squat (SLDS) test
A reliable patellar tendon pain provocation test, will be used to assess pain during function
Measured: 0,6, 12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
Jump test
Squat jump and Counter movement Jump will be used to assess patellar tendinopathy caused functional deficits on the injured site compared with the non-injured site
Measured: 0 and 12 wks
Mechanical properties
Synchronized tendon elongation with the use of ultrasonography along with force measures, will be used during voluntary contractions to determine mechanical properties
Measured: 0 and 12 wks
Muscle strength
Maximal muscle strength of the knee extensors is obtained during a maximal voluntary contractions
Measured: 0 and 12 wks
Tendon dimensions and structure
Measured by MRI
Measured: 0 and 12 wks
Treatment satisfaction
Questionnaire
Measured: 12 wks + 1 yr follow-up + Long-term follow-up (2-4 yr)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start29 Mar 2017
- Primary completion25 Jun 2019
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Sofie Agergaard, Bispebjerg Hospital
- Investigators
- Peter Magnusson, Professor, Study director, Bispebjerg Hospital, University of CopenhagenAnne-Sofie Agergaard, Phd.Student, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096067
- Sponsor's protocol ID
- BBH131
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2017
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agergaard AS, Svensson RB, Malmgaard-Clausen NM, Couppe C, Hjortshoej MH, Doessing S, Kjaer M, Magnusson SP. Clinical Outcomes, Structure, and Function Improve With Both Heavy and Moderate Loads in the Treatment of Patellar Tendinopathy: A Randomized Clinical Trial. Am J Sports Med. 2021 Mar;49(4):982-993. doi: 10.1177/0363546520988741. Epub 2021 Feb 22.
PubMed 33616456
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patellar Tendinopathy; Influence of Load Magnitude on Clinical Outcome, Tendon Structure and Function
- ClinicalTrials.gov ID
- NCT03096067
- Acronym / sponsor ID
- BBH131
- Conditions
- Patellar Tendinopathy, Jumper's Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 30 Mar 2017 (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 this project is to investigate if the magnitude of a loading based 12 weeks rehabilitation regime for patellar tendinopathy influence the clinical outcome, tendon structure and function.
The investigators hypothesize that a greater magnitude (90% of 1RM) of loading will yield a more positive clinical outcome, tendon structure and function in patients with patellar tendinopathy compared to a lower magnitude of loading (55% of 1 RM) when total exercise volume is equal in both groups.
Detailed description
Randomized controlled intervention study with one year follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy slow resistance group | Active comparator | Other: Heavy slow resistance trainingHeavy slow resistance training. Three times weekly for 12 weeks. |
| Moderate slow resistance group | Experimental | Other: Moderate slow resistance trainingModerate slow resistance training. Three times weekly for 12 weeks. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Uni- or bilateral patellar tendinopathy
- Symptoms > 3 months
- Ultrasonographical tendon swelling
- Ultrasonographical hypo-echoic area with doppler
- BMI 18.5-30
Key exclusion criteria (7 listed)
- Patellar tendinopathy > 12 month
- Previous knee surgery
- Confounding diagnosis to the knee joint
- Diabetes or arthritis
- Previous corticosteroid injection for patellar tendinopathy
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 |
|---|---|---|
| Heavy slow resistance trainingResistance training for knee extensors. The exercise will be performed at 90% of 1 RM and slowly (6 s/repetition). | Other | Heavy slow resistance group |
| Moderate slow resistance trainingResistance training for knee extensors. The exercise will be performed at 55% of 1 RM and slowly (6 s/repetition). | Other | Moderate slow resistance group |
Primary outcome
Change from baseline Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P) at 12 wks
Time frame: 0-12 wks
Patient reported outcome regarding symptoms, function and the ability to participate in sports
9 secondary outcomes
Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P)
Time frame: 0 and 6 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
Pain rating on numeric rating scale (NRS) and activity level of sporting activities (h/wk)
Time frame: 0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
Tendon thickness and Doppler activity
Time frame: 0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
Single-leg decline squat (SLDS) test
Time frame: 0,6, 12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
Jump test
Time frame: 0 and 12 wks
Mechanical properties
Time frame: 0 and 12 wks
Muscle strength
Time frame: 0 and 12 wks
Tendon dimensions and structure
Time frame: 0 and 12 wks
Treatment satisfaction
Time frame: 12 wks + 1 yr follow-up + Long-term follow-up (2-4 yr)
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 8 Mar 2022.
- Derived from this study: PubMed 33616456Agergaard AS, Svensson RB, Malmgaard-Clausen NM, Couppe C, Hjortshoej MH, Doessing S, Kjaer M, Magnusson SP. Clinical Outcomes, Structure, and Function Improve With Both Heavy and Moderate Loads in the Treatment of Patellar Tendinopathy: A Randomized Clinical Trial. Am J Sports Med. 2021 Mar;49(4):982-993. doi: 10.1177/0363546520988741. Epub 2021 Feb 22.
- 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.
Peter Magnusson, Professor study director
Bispebjerg Hospital, University of Copenhagen
Anne-Sofie Agergaard, Phd.Student principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heavy slow resistance training and Moderate slow resistance training 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 5 inclusion and 7 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 8 Mar 2022. 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?
Change from baseline Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P) at 12 wks (time frame: 0-12 wks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03096067, which also lists 1 linked publication.
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 8 Mar 2022.