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

• ClinicalTrials.gov Identifier: NCT03917849
• Recruitment Status: Completed
• First Posted: April 17, 2019
• Last Update Posted: July 15, 2020
• Sponsor: Universidad Nacional de Córdoba
• Information provided by (Responsible Party): Diego Andres Ruffino, Universidad Nacional de Córdoba

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Inertial Flywheel vs Heavy Slow Resistance Training Among Athletes With Patellar Tendinopathy
• Actual Study Start Date: January 2, 2018
• Actual Primary Completion Date: March 22, 2020
• Actual Study Completion Date: March 22, 2020

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Argentina

Universidad Nacional de Cordoba

Córdoba, C, Argentina, 5000

Universidad Nacional de Cordoba

Cordoba, Argentina, 5000

Sponsors and Collaborators

Universidad Nacional de Córdoba

Investigators

• Study Director: Vilma Campana, Dr; Departments of Biomedical Physics - University of Cordoba Argentina

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Diego Andres Ruffino, Principal Investigator, Universidad Nacional de Córdoba
• ClinicalTrials.gov Identifier: NCT03917849
• Other Study ID Numbers: UCordoba
• First Posted: April 17, 2019
• Last Update Posted: July 15, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• 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; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries