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CompletedNCT03096067Updated Mar 8, 2022

Patellar Tendinopathy - The Effect of Load Magnitude in Exercise-based Treatment

An interventional study of Heavy slow resistance training and Moderate slow resistance training in Patellar Tendinopathy and Jumper's Knee, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to male participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-03-08.

Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study 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.

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

02

Conditions studied

  • Patellar Tendinopathy
  • Jumper's Knee

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03

In context

Tendinopathy

413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.

This study's enrollment of 44 is below the median of 50 across 339 interventional studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    Heavy slow resistance group

    Heavy slow resistance training. Three times weekly for 12 weeks.

    Other: Heavy slow resistance training

  • Experimental
    Moderate slow resistance group

    Moderate slow resistance training. Three times weekly for 12 weeks.

    Other: Moderate slow resistance training

Interventions

  • OtherHeavy slow resistance training

    Resistance training for knee extensors. The exercise will be performed at 90% of 1 RM and slowly (6 s/repetition).

  • OtherModerate slow resistance training

    Resistance training for knee extensors. The exercise will be performed at 55% of 1 RM and slowly (6 s/repetition).

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 0-12 wks

Secondary outcomes

  1. Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P)

    Patient reported outcome regarding symptoms, function and the ability to

    Time frame: 0 and 6 wks + 1 yr follow up + Long-term follow-up (2-4 yr)

  2. Pain rating on numeric rating scale (NRS) and activity level of sporting activities (h/wk)

    Questionnaire

    Time frame: 0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)

  3. Tendon thickness and Doppler activity

    Measured by ultrasound

    Time frame: 0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)

  4. Single-leg decline squat (SLDS) test

    A reliable patellar tendon pain provocation test, will be used to assess pain during function

    Time frame: 0,6, 12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)

  5. 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

    Time frame: 0 and 12 wks

  6. Mechanical properties

    Synchronized tendon elongation with the use of ultrasonography along with force measures, will be used during voluntary contractions to determine mechanical properties

    Time frame: 0 and 12 wks

  7. Muscle strength

    Maximal muscle strength of the knee extensors is obtained during a maximal voluntary contractions

    Time frame: 0 and 12 wks

  8. Tendon dimensions and structure

    Measured by MRI

    Time frame: 0 and 12 wks

  9. Treatment satisfaction

    Questionnaire

    Time frame: 12 wks + 1 yr follow-up + Long-term follow-up (2-4 yr)

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Study locations

1 site
  • Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
    Copenhagen, 2400, Denmark
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03096067
Lead sponsor
Bispebjerg Hospital
Responsible party
Anne-Sofie Agergaard (PhD Student, MSc. in Physiotherapy, PT, Bispebjerg Hospital) — Principal investigator
First posted
Mar 30, 2017
Start date
Mar 29, 2017
Primary completion
Jun 25, 2019
Completion
Oct 1, 2021
Last update
Mar 8, 2022

Study contacts

Peter Magnusson, Professor
study director · Bispebjerg Hospital, University of Copenhagen
Anne-Sofie Agergaard, Phd.Student
principal investigator · Bispebjerg Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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