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.

Study Overview

• Status: Completed
• Conditions: Jumper's Knee; Patellar Tendinitis
• Intervention / Treatment: Behavioral: Exercises program for patellar tendinopathy

Detailed Description

Randomized controlled intervention study

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, 5000
    • Universidad Nacional de Córdoba
  • C
    • Córdoba, C, Argentina, 5000
      • Universidad Nacional de Córdoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 - 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 - 12 weeks
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."	12 weeks
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.	12 weeks
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.	12 weeks
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.	0 - 12 weeks
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.	0 - 12 weeks
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.	0 - 12 weeks

Collaborators and Investigators

• Sponsor: Universidad Nacional de Córdoba
• Investigators: Study Director: Vilma Campana, Dr, Departments of Biomedical Physics - University of Cordoba Argentina

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): March 22, 2020
• Study Completion (Actual): March 22, 2020

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 13, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: UCordoba

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No