NCT03096067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

March 29, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

2.2 years

First QC Date

March 17, 2017

Last Update Submit

March 7, 2022

Conditions

Patellar TendinopathyJumper's Knee

Outcome Measures

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

    0-12 wks

Secondary Outcomes (9)

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

    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)

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

  • Tendon thickness and Doppler activity

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

  • Single-leg decline squat (SLDS) test

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

  • Jump test

    0 and 12 wks

  • +4 more secondary outcomes

Study Arms (2)

Heavy slow resistance group

ACTIVE COMPARATOR

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

Other: Heavy slow resistance training

Moderate slow resistance group

EXPERIMENTAL

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

Other: Moderate slow resistance training

Interventions

Heavy slow resistance trainingOTHER

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

Heavy slow resistance group
Moderate slow resistance trainingOTHER

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

Moderate slow resistance group

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Uni- or bilateral patellar tendinopathy
  • Symptoms \> 3 months
  • Ultrasonographical tendon swelling
  • Ultrasonographical hypo-echoic area with doppler
  • BMI 18.5-30

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, 2400, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 33616456DERIVED

Study Officials

  • Peter Magnusson, Professor

    Bispebjerg Hospital, University of Copenhagen

    STUDY DIRECTOR

  • Anne-Sofie Agergaard, Phd.Student

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student, MSc. in Physiotherapy, PT

Study Record Dates

First Submitted

March 17, 2017

First Posted

March 30, 2017

Study Start

March 29, 2017

Primary Completion

June 25, 2019

Study Completion

October 1, 2021

Last Updated

March 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)