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

Patellar Tendinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917849
• Other study ID #: UCordoba
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: March 22, 2020

Study information

• Verified date: July 2020
• Source: Universidad Nacional de Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Randomized controlled intervention study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 22, 2020
• Est. primary completion date: March 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Jumper's Knee
• Patellar Tendinitis
• Tendinopathy

Intervention

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

Locations

Country	Name	City	State
Argentina	Universidad Nacional de Cordoba	Cordoba
Argentina	Universidad Nacional de Cordoba	Córdoba	C

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Córdoba

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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