CClinicalTrials.gg
CompletedNCT03917849Updated Jul 15, 2020

Efficacy of Inertial Flywheel vs Heavy Slow Resistance Training Among Athletes With Patellar Tendinopathy

An interventional study of Exercises program for patellar tendinopathy in Patellar Tendinitis and Jumper's Knee, sponsored by Universidad Nacional de Córdoba. Completed at 2 sites in Argentina. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-07-15.

Sponsored by Universidad Nacional de Córdoba · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2018, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of this project is to investigate the efficacy of Inertial Flywheel Resistance program vs Heavy slow resistance in patients with chronic patellar tendinopathy.

The investigators hypothesize that Inertial Flywheel Resistance program will yield a more positive clinical outcome and function in patients with patellar tendinopathy compared to heavy slow resistance group.

Read the detailed description

Randomized controlled intervention study

02

Conditions studied

  • Patellar Tendinitis
  • Jumper's Knee

Browse trials for

03

In context

Tendinopathy

413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.

This study's enrollment of 42 is below the median of 50 across 339 interventional studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

Universidad Nacional de Córdoba is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of patellar tendinopathy
  • Symptoms > 3 months
  • Pain localized to the inferior pole of the patella
  • Victorian Institute of Sport Assessment (VISA) score less than 80 points
  • Palpation tenderness of the patellar tendon
  • Abnormal tendon (hypoechoic) confirmed by ultrasonography.

Exclusion criteria

Exclusion Criteria:

  • Previous knee surgery
  • Confounding diagnosis to the knee joint
  • Previous corticosteroids injections
  • Arthritis or diabetes
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Heavy slow resistance training

    The program is performed 3 times per week using resistance equipment in a fitness center. Each session consists of three 2-legged loaded quadriceps and lower limb kinetic chain exercises. The patients complete 3 or 4 sets in each exercise with a 2- to 3-minute rest between sets and a 5-minute rest period between the 3 exercises. The number of repetitions decreases, and load gradually increases, every week. The repetitions and loads are as follows: 3 times, 15-repetition maximum (15RM ), in week 1; 3 times, 12RM , in weeks 2 to 3; 4 times, 10RM , in weeks 4 to 5; 4 times, 8RM , in weeks 6 to 8; and 4 times, 6RM , in weeks 9 to 12.

    Behavioral: Exercises program for patellar tendinopathy

  • Experimental
    Inertial flywheel resistance training

    The program is performed 3 times per week using resistance equipment in a fitness center. Inertial flywheel resistance is a type of strength training; which is based on the increasing demands on eccentric action (breaking) after a concentric action (acceleration), due to the inertial load caused during the return movement. The patients complete 12 repetition máximum (RM) with moment inertia 0.05 m² from week 1-6 and 8 repetition máximum (RM) with moment inertia = 0.10 m² from week 6-12.

    Behavioral: Exercises program for patellar tendinopathy

Interventions

  • BehavioralExercises program for patellar tendinopathy

    To compare the effectiveness of the inertial flywheel resistance program versus slow heavy resistance in patients with chronic patellar tendinopathy

06

What researchers measure

Primary outcomes

  1. Victorian Institute of Sports Assessment (VISA-P questionnaire)

    Self-administered questionnaire. Consists of 8 items; 6 are used to evaluate pain levels or disability in daily activities and specific functional tests and 2 provide information regarding ability to play sport. Response options for each item are provided on a numeric rating scale (from 0 to 10), with higher scores indicating lower levels of pain or disability for all items other than 7 and 8, for which options have weighted scores.

    Time frame: 0 - 12 weeks

Secondary outcomes

  1. Patient-Specific Functional Scale

    Self-reported patient-specific outcome measure assess functional change, primarily in patients presenting with musculoskeletal disorders. Patients are asked to identify up to 3 important activities they are unable to perform or are having difficulty with as a result of their problem. In addition to identifying the activities, patients are asked to rate, on an 11-point scale, the current level of difficulty associated with each activity. Following the intervention, patients are asked again to rate the activities previously identified.

    Time frame: 0 - 12 weeks

  2. Patient Global Impression of Change

    Register patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."

    Time frame: 12 weeks

  3. Adverse events

    To capture all adverse events and side effects that occurred after exercises protocol. Patients reported any changes or any symptoms. If a question was answered "yes", we asked for further comments.

    Time frame: 12 weeks

  4. Adherence self-report questionnaire

    Patients were asked to choose one of six descriptions (from level 1 = perfect adherence to level 6 = nonadherence) to express exercise treatment at the end of the twelve weeks study period.

    Time frame: 12 weeks

  5. Single-leg decline squat (SLDS) test

    A reliable patellar tendon pain provocation test, will be used to assess pain. Pain is rated on an 11-point numeric rating scale, where 0 is no pain and 10 is the worst pain imaginable.

    Time frame: 0 - 12 weeks

  6. Knee extension machine test

    A reliable patellar tendon pain provocation test, will be used to assess pain. Pain is rated on an 11-point numeric rating scale, where 0 is no pain and 10 is the worst pain imaginable.

    Time frame: 0 - 12 weeks

  7. Jump test

    Counter movement Jump and Triple hop for distance will be used to assess patellar tendinopathy caused functional deficits on the injured site compared with the non-injured site. The distance is measured in centimeters.

    Time frame: 0 - 12 weeks

07

Study locations

2 sites
  • Universidad Nacional de Cordoba
    Córdoba, C 5000, Argentina
  • Universidad Nacional de Cordoba
    Cordoba, 5000, Argentina
08

References and documents

Publications

  • Ruffino D, Malliaras P, Marchegiani S, Campana V. Inertial flywheel vs heavy slow resistance training among athletes with patellar tendinopathy: A randomised trial. Phys Ther Sport. 2021 Nov;52:30-37. doi: 10.1016/j.ptsp.2021.08.002. Epub 2021 Aug 4. PubMed 34384941 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03917849
Lead sponsor
Universidad Nacional de Córdoba
Responsible party
Diego Andres Ruffino (Principal Investigator, Universidad Nacional de Córdoba) — Principal investigator
First posted
Apr 17, 2019
Start date
Jan 2, 2018
Primary completion
Mar 22, 2020
Completion
Mar 22, 2020
Last update
Jul 15, 2020

Study contacts

Vilma Campana, Dr
study director · Departments of Biomedical Physics - University of Cordoba Argentina

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion