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

Primary Purpose

Patellar Tendinitis, Jumper's Knee

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Exercises program for patellar tendinopathy
Sponsored by
Universidad Nacional de Córdoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellar Tendinitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad Nacional de Cordoba
  • Universidad Nacional de Cordoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Heavy slow resistance training

Inertial flywheel resistance training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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."
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.
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.
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.
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.
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.

Full Information

First Posted
April 8, 2019
Last Updated
July 13, 2020
Sponsor
Universidad Nacional de Córdoba
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1. Study Identification

Unique Protocol Identification Number
NCT03917849
Brief Title
Efficacy of Inertial Flywheel vs Heavy Slow Resistance Training Among Athletes With Patellar Tendinopathy
Official Title
Efficacy of Inertial Flywheel vs Heavy Slow Resistance Training Among Athletes With Patellar Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
March 22, 2020 (Actual)
Study Completion Date
March 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional de Córdoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
Detailed Description
Randomized controlled intervention study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinitis, Jumper's Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heavy slow resistance training
Arm Type
Experimental
Arm Description
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.
Arm Title
Inertial flywheel resistance training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercises program for patellar tendinopathy
Intervention Description
To compare the effectiveness of the inertial flywheel resistance program versus slow heavy resistance in patients with chronic patellar tendinopathy
Primary Outcome Measure Information:
Title
Victorian Institute of Sports Assessment (VISA-P questionnaire)
Description
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.
Time Frame
0 - 12 weeks
Secondary Outcome Measure Information:
Title
Patient-Specific Functional Scale
Description
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.
Time Frame
0 - 12 weeks
Title
Patient Global Impression of Change
Description
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."
Time Frame
12 weeks
Title
Adverse events
Description
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.
Time Frame
12 weeks
Title
Adherence self-report questionnaire
Description
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.
Time Frame
12 weeks
Title
Single-leg decline squat (SLDS) test
Description
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.
Time Frame
0 - 12 weeks
Title
Knee extension machine test
Description
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.
Time Frame
0 - 12 weeks
Title
Jump test
Description
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.
Time Frame
0 - 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilma Campana, Dr
Organizational Affiliation
Departments of Biomedical Physics - University of Cordoba Argentina
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Nacional de Cordoba
City
Córdoba
State/Province
C
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Universidad Nacional de Cordoba
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34384941
Citation
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.
Results Reference
derived

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

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