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Completed

NCT Number: NCT03917849

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Nacional de Cordoba, Córdoba, C, Argentina

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About this study

Randomized controlled intervention study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Exercises program for patellar tendinopathy

Behavioral

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

Primary outcomes

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

    Time frame: 0 - 12 weeks

    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.

Secondary outcomes

  1. Patient-Specific Functional Scale

    Time frame: 0 - 12 weeks

    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.

  2. Patient Global Impression of Change

    Time frame: 12 weeks

    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."

  3. Adverse events

    Time frame: 12 weeks

    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.

  4. Adherence self-report questionnaire

    Time frame: 12 weeks

    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.

  5. Single-leg decline squat (SLDS) test

    Time frame: 0 - 12 weeks

    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.

  6. Knee extension machine test

    Time frame: 0 - 12 weeks

    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.

  7. Jump test

    Time frame: 0 - 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Córdoba

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 17, 2019
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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