Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03096067
Recruitment Status : Completed
First Posted : March 30, 2017
Last Update Posted : March 8, 2022
Sponsor:
Information provided by (Responsible Party):
Anne-Sofie Agergaard, Bispebjerg Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Patellar Tendinopathy Jumper's Knee Other: Heavy slow resistance training Other: Moderate slow resistance training Not Applicable

Detailed Description:
Randomized controlled intervention study with one year follow-up
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Heavy slow resistance group
Heavy slow resistance training. Three times weekly for 12 weeks.
 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.
 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).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Muscle strength [ Time Frame: 0 and 12 wks ]
    Maximal muscle strength of the knee extensors is obtained during a maximal voluntary contractions

  8. Tendon dimensions and structure [ Time Frame: 0 and 12 wks ]
    Measured by MRI

  9. Treatment satisfaction [ Time Frame: 12 wks + 1 yr follow-up + Long-term follow-up (2-4 yr) ]
    Questionnaire


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
Denmark
Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Layout table for investigator information
Study Director: Peter Magnusson, Professor Bispebjerg Hospital, University of Copenhagen
Principal Investigator: Anne-Sofie Agergaard, Phd.Student Bispebjerg Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries