NCT07682051

Brief Summary

This study aims to investigate the effects of two different resistance training interventions on the structural, morphological, mechanical, and functional properties of the thigh muscles (in particular the quadriceps femoris) and the patellar tendon, in participants with current patellar tendinopathy.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Nov 2027

First Submitted

Initial submission to the registry

June 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

12 months

First QC Date

June 23, 2026

Last Update Submit

June 30, 2026

Conditions

Outcome Measures

Primary Outcomes (8)

  • Tendon Thickness

    Anteroposterior thickness of the patellar tendon (in milimiters) measures by B-Mode Ultrasound (Aixplorer V12.3 Supersonic Imaging, France) with a SuperLinear 15-4 MHz probe. Three images at the same position will be taken for further analysis with the software ImageJ.

    From enrollment to the end of training at 12 weeks

  • Tendon sitffness

    Stiffness of the patellar tendon (in kilopascal) will be measured with Shear-Wave Elastrography (Aixplorer V12.3, Supersonic Imaging, France). The measurement site is 0.5cm from the patellar apex, and five videos of 15 seconds will be recorded for further analysis with Matlab.

    From enrollment to the end of training at 12 weeks

  • Tendon CSA

    Cross-sectional area of the patellar tendon (in centimiters) on its proximal, middle and distal part, will be measured with B-Mode Ultrasound (Aixplorer V12.3, Supersonic Imaging, France). Three images per site, accounting for a total of 9 images, will be taken for further analysis with the software ImageJ.

    From enrollment to the end of training at 12 weeks

  • Fascicle length

    Length of the fascicles of the vastus lateralis muscle (in centimiters) will be measures with Extended Field of View (Panoramic) B-Mode Ultrasound (Aixplorer V12.3, Supersonic Imaging, France). Five images will be taken for further analysis with the software ImageJ.

    From enrollment to the end of training at 12 weeks

  • Muscle Strength

    Maximum voluntary isometric torque of the knee extensors (in newton per meters) will be measured with the Isomed2000, Germany device. Three trials will be performed, with three minutes of rest in between, and the trial with the maximum peak torque will be taken for analysis.

    From enrollment to the end of training at 12 weeks

  • 1 repetition maximum

    Maximum strength of the leg press and knee extension exercises (in kilograms) will be measured with the leg press and knee extension devices (compass540, Physiomed, Germany). Participants will perform repetitions with increasing weights, until they can perform a maximum of eight repetitions with a specific weight. This weight will be then used to estimate their maximum 1RM, to further calculate the training loads.

    From enrollment to the end of training at 12 weeks

  • Overall Pain

    Pain assessed at rest and during a single-leg-decline squat (SLDS) will be assessed with the numerical rating scale of 11 points called Visual Analogue Scale (VAS). Higher values mean higher pain levels.

    From enrollment to the end of training at 12 weeks

  • Functionality

    Functionality assessed with the VISA-P Questionnaire. This questionnaire includes 10 questions with a score from 0 to 10, for a maximum questionnaire score of 100 points. Higher scores mean better functionality.

    From enrollment to the end of training at 12 weeks

Secondary Outcomes (5)

  • Tendon Neovascularization

    From enrollment to the end of training at 12 weeks

  • Young's Modulus

    From enrollment to the end of training at 12 weeks

  • Muscle Thickness

    From enrollment to the end of training at 12 weeks

  • Muscle Stiffness

    From enrollment to the end of training at 12 weeks

  • Jump Height

    From enrollment to the end of training at 12 weeks

Study Arms (2)

Eccentric Training

EXPERIMENTAL

Participants between 18 and 50 years of age with patellar tendinopathy who will receive the eccentric intervention only.

Other: Eccentric Training

Heavy-Slow Resistance Training

EXPERIMENTAL

Participants between 18 and 50 years of age with patellar tendinopathy who will receive the heavy-slow resistance training intervention only.

Other: Heavy-Slow Resistance Training

Interventions

The intervention consists of 12 weeks of resistance training, with a frequency of three times per week. Participants in this group will perform two exercises on a leg press and knee extension machine at their own training facility. This intervention has a repetition time of four seconds, with only the eccentric phase of the movement being performed. They will rest between two and three minutes between sets and will perform the exercises as long as their pain level is less than or equal to four on a pain scale from 0-10. The training parameters are the following, applying to both leg press and knee extension exercises: Week 1: 3 sets of 15 repetitions at 60% of their 1-repetition maximum (1RM) Week 2 and 3: 3 sets of 12 repetitions at 70% of their 1RM Week 4 and 5: 3 sets of 10 repetitions at 75% of their 1RM Week 6 to 12: 4 sets of 8 repetitions at 80% of their 1RM.

Also known as: ECC
Eccentric Training

The intervention consists of 12 weeks of resistance training, with a frequency of three times per week. Participants in this group will perform two exercises on a leg press and knee extension machine at their own training facility. This intervention has a repetition time of four seconds, of which two seconds will be spent on the concentric phase and two seconds on the eccentric phase of the movement being performed. They will rest between two and three minutes between sets and will perform the exercises as long as their pain level is less than or equal to four on a pain scale from 0-10. The training parameters are the following, applying to both leg press and knee extension exercises: Week 1: 3 sets of 15 repetitions at 60% of their 1-repetition maximum (1RM) Week 2 and 3: 3 sets of 12 repetitions at 70% of their 1RM Week 4 and 5: 3 sets of 10 repetitions at 75% of their 1RM Week 6 to 12: 4 sets of 8 repetitions at 80% of their 1RM.

Also known as: HSRT
Heavy-Slow Resistance Training

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 50 years of age
  • Pain at the inferior pole of the patella, longer than 3 months
  • Active lifestyle (sport/exercise minimum 3 times per week)
  • No previous injuries or surgeries on the affected leg

You may not qualify if:

  • Corticoid injections in the last 6 months
  • Current intake of pain or non-steroidal anti-inflammatory drugs
  • Additional tendinopathy treatments in the last 6 months (i.e., physical therapy, shock-wave therapy, drug interventions, etc.)
  • Neuromuscular or cardiovascular associated diseases or conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Graz

Graz, Styria, 8010, Austria

Location

Study Officials

  • Josefina Manieu Seguel, M.Sc.

    University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is designed as a randomized controlled trial (RCT). This means the participants will be randomly assigned to one of two intervention groups: * Eccentric group: the intervention group will perform an eccentric resistance training protocol for 12 weeks. This means the focus is on the deceleration or "return" part of the movement. * Heavy-slow resistance training: this group will perform both the concentric and the eccentric parts of the exercises for 12 weeks. In simple words, a closer-to-normal strength training protocol.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant - PhD Student

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 2, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

July 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Metrics obtained from the outcome variables. No personal information will be shared (e.g., name, gender, anthropometrics)

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The IPD and supporting information will be available starting June 2026, archived and available to the specific members mentioned above for a period of 10 years (June 2036).
Access Criteria
The supervisor and the senior postdoctoral researcher will have access to the information. They will have access to the metrics of the outcome variables of each participant. This includes: tendon stiffness, tendon thickness, tendon cross-sectional area, tendon neovascularization, tendon Young's modulus, muscle thickness, muscle stiffness, fascicle length, strength test results, jump height, pain scores, and questionnaire scores. They will have access through a secure University server that stores the data under the principal investigator's name, which allows selective access to specified people.

Locations