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

Primary Purpose

Patellar Tendinopathy, Jumper's Knee

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Heavy slow resistance training
Moderate slow resistance training
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellar Tendinopathy

Eligibility Criteria

20 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Heavy slow resistance group

Moderate slow resistance group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P)
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)
Questionnaire
Tendon thickness and Doppler activity
Measured by ultrasound
Single-leg decline squat (SLDS) test
A reliable patellar tendon pain provocation test, will be used to assess pain during function
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
Mechanical properties
Synchronized tendon elongation with the use of ultrasonography along with force measures, will be used during voluntary contractions to determine mechanical properties
Muscle strength
Maximal muscle strength of the knee extensors is obtained during a maximal voluntary contractions
Tendon dimensions and structure
Measured by MRI
Treatment satisfaction
Questionnaire

Full Information

First Posted
March 17, 2017
Last Updated
March 7, 2022
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03096067
Brief Title
Patellar Tendinopathy - The Effect of Load Magnitude in Exercise-based Treatment
Official Title
Treatment of Patellar Tendinopathy; Influence of Load Magnitude on Clinical Outcome, Tendon Structure and Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
June 25, 2019 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Randomized controlled intervention study with one year follow-up

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinopathy, Jumper's Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heavy slow resistance group
Arm Type
Active Comparator
Arm Description
Heavy slow resistance training. Three times weekly for 12 weeks.
Arm Title
Moderate slow resistance group
Arm Type
Experimental
Arm Description
Moderate slow resistance training. Three times weekly for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Heavy slow resistance training
Intervention Description
Resistance training for knee extensors. The exercise will be performed at 90% of 1 RM and slowly (6 s/repetition).
Intervention Type
Other
Intervention Name(s)
Moderate slow resistance training
Intervention Description
Resistance training for knee extensors. The exercise will be performed at 55% of 1 RM and slowly (6 s/repetition).
Primary Outcome Measure Information:
Title
Change from baseline Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P) at 12 wks
Description
Patient reported outcome regarding symptoms, function and the ability to participate in sports
Time Frame
0-12 wks
Secondary Outcome Measure Information:
Title
Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P)
Description
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)
Title
Pain rating on numeric rating scale (NRS) and activity level of sporting activities (h/wk)
Description
Questionnaire
Time Frame
0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
Title
Tendon thickness and Doppler activity
Description
Measured by ultrasound
Time Frame
0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)
Title
Single-leg decline squat (SLDS) test
Description
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)
Title
Jump test
Description
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
Title
Mechanical properties
Description
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
Title
Muscle strength
Description
Maximal muscle strength of the knee extensors is obtained during a maximal voluntary contractions
Time Frame
0 and 12 wks
Title
Tendon dimensions and structure
Description
Measured by MRI
Time Frame
0 and 12 wks
Title
Treatment satisfaction
Description
Questionnaire
Time Frame
12 wks + 1 yr follow-up + Long-term follow-up (2-4 yr)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Magnusson, Professor
Organizational Affiliation
Bispebjerg Hospital, University of Copenhagen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anne-Sofie Agergaard, Phd.Student
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33616456
Citation
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.
Results Reference
derived

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

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