Patellar Tendinopathy - The Effect of Load Magnitude in Exercise-based Treatment
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ClinicalTrials.gov Identifier: NCT03096067 |
Recruitment Status :
Completed
First Posted : March 30, 2017
Last Update Posted : March 8, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Patellar Tendinopathy Jumper's Knee | Other: Heavy slow resistance training Other: Moderate slow resistance training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Patellar Tendinopathy; Influence of Load Magnitude on Clinical Outcome, Tendon Structure and Function |
Actual Study Start Date : | March 29, 2017 |
Actual Primary Completion Date : | June 25, 2019 |
Actual Study Completion Date : | October 1, 2021 |
Arm | Intervention/treatment |
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Active Comparator: Heavy slow resistance group
Heavy slow resistance training. Three times weekly for 12 weeks.
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Other: Heavy slow resistance training
Resistance training for knee extensors. The exercise will be performed at 90% of 1 RM and slowly (6 s/repetition). |
Experimental: Moderate slow resistance group
Moderate slow resistance training. Three times weekly for 12 weeks.
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Other: Moderate slow resistance training
Resistance training for knee extensors. The exercise will be performed at 55% of 1 RM and slowly (6 s/repetition). |
- 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
- 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) ]Patient reported outcome regarding symptoms, function and the ability to
- 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) ]Questionnaire
- Tendon thickness and Doppler activity [ Time Frame: 0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr) ]Measured by ultrasound
- Single-leg decline squat (SLDS) test [ Time Frame: 0,6, 12 wks + 1 yr follow up + Long-term follow-up (2-4 yr) ]A reliable patellar tendon pain provocation test, will be used to assess pain during function
- Jump test [ Time Frame: 0 and 12 wks ]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
- Mechanical properties [ Time Frame: 0 and 12 wks ]Synchronized tendon elongation with the use of ultrasonography along with force measures, will be used during voluntary contractions to determine mechanical properties
- Muscle strength [ Time Frame: 0 and 12 wks ]Maximal muscle strength of the knee extensors is obtained during a maximal voluntary contractions
- Tendon dimensions and structure [ Time Frame: 0 and 12 wks ]Measured by MRI
- Treatment satisfaction [ Time Frame: 12 wks + 1 yr follow-up + Long-term follow-up (2-4 yr) ]Questionnaire

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Ages Eligible for Study: | 20 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Uni- or bilateral patellar tendinopathy
- Symptoms > 3 months
- Ultrasonographical tendon swelling
- Ultrasonographical hypo-echoic area with doppler
- BMI 18.5-30
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096067
Denmark | |
Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital | |
Copenhagen, Denmark, 2400 |
Study Director: | Peter Magnusson, Professor | Bispebjerg Hospital, University of Copenhagen | |
Principal Investigator: | Anne-Sofie Agergaard, Phd.Student | Bispebjerg Hospital |
Responsible Party: | Anne-Sofie Agergaard, PhD Student, MSc. in Physiotherapy, PT, Bispebjerg Hospital |
ClinicalTrials.gov Identifier: | NCT03096067 |
Other Study ID Numbers: |
BBH131 |
First Posted: | March 30, 2017 Key Record Dates |
Last Update Posted: | March 8, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries |