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Flywheel Inertial Resistance vs Heavy Slow Resistance in Patellar Tendinopathy

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ClinicalTrials.gov Identifier: NCT03917849
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Diego Andres Ruffino, Universidad Nacional de Córdoba

Brief 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.


Condition or disease Intervention/treatment Phase
Patellar Tendinitis Jumper's Knee Behavioral: Exercises program for patellar tendinopathy Not Applicable

Detailed Description:
Randomized controlled intervention study

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Flywheel Inertial Resistance vs Heavy Slow Resistance Training as Treatment for Chronic Patellar Tendinopathy
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917849


Contacts
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Contact: Diego Ruffino, PT (PhD Student) +5493516162201 licdiegoruffino@hotmail.com
Contact: Vilma Campana, Dr +5493515909500 campanav@hotmail.com

Locations
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Argentina
Universidad Nacional de Cordoba Recruiting
Córdoba, C, Argentina, 5000
Contact: Diego Ruffino, PT    +5493516162201    licdiegoruffino@hotmail.com   
Universidad Nacional de Cordoba Recruiting
Cordoba, Argentina, 5000
Contact: Diego Ruffino, PT         
Principal Investigator: Diego Ruffino, PT         
Sponsors and Collaborators
Universidad Nacional de Córdoba
Investigators
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Study Director: Vilma Campana, Dr Departments of Biomedical Physics - University of Cordoba Argentina

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Responsible Party: Diego Andres Ruffino, Principal Investigator, Universidad Nacional de Córdoba
ClinicalTrials.gov Identifier: NCT03917849     History of Changes
Other Study ID Numbers: UCordoba
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries