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

• Sponsor: Bispebjerg Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03096067
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Actual Duration (Months): 54.1
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Patellar Tendinopathy; Jumper's Knee	Other: Heavy slow resistance training; Other: Moderate slow resistance training	N/A

Detailed Description

Randomized controlled intervention study with one year follow-up

Study Design

• Study Type: Interventional
• 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: Mar 29, 2017
• Actual Primary Completion Date: Jun 25, 2019
• Actual Study Completion Date: Oct 1, 2021

Arms and Interventions

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

Primary Outcome Measures

1. Change from baseline Victorian Institute of Sports Assessment - Patella Questionnaire (VISA-P) at 12 wks [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) [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) [0,6,12 wks + 1 yr follow up + Long-term follow-up (2-4 yr)]

   Questionnaire

3. Tendon thickness and Doppler activity [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 [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 [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 [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 [0 and 12 wks]

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

8. Tendon dimensions and structure [0 and 12 wks]

   Measured by MRI

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

   Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital	Copenhagen		Denmark	2400

Sponsors and Collaborators

• Bispebjerg Hospital

Investigators

• Study Director: Peter Magnusson, Professor, Bispebjerg Hospital, University of Copenhagen
• Principal Investigator: Anne-Sofie Agergaard, Phd.Student, Bispebjerg Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anne-Sofie Agergaard, PhD Student, MSc. in Physiotherapy, PT, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT03096067
• Other Study ID Numbers: BBH131
• First Posted: Mar 30, 2017
• Last Update Posted: Mar 8, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tendinopathy

Study Results

No Results Posted as of Mar 8, 2022