NCT03917849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

April 8, 2019

Last Update Submit

July 13, 2020

Conditions

Patellar TendinitisJumper's Knee

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Patient-Specific Functional Scale

    0 - 12 weeks

  • Patient Global Impression of Change

    12 weeks

  • Adverse events

    12 weeks

  • Adherence self-report questionnaire

    12 weeks

  • Single-leg decline squat (SLDS) test

    0 - 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Heavy slow resistance training

EXPERIMENTAL

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

Inertial flywheel resistance training

EXPERIMENTAL

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

Interventions

Exercises program for patellar tendinopathyBEHAVIORAL

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

Heavy slow resistance trainingInertial flywheel resistance training

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous knee surgery
  • Confounding diagnosis to the knee joint
  • Previous corticosteroids injections
  • Arthritis or diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad Nacional de Cordoba

Córdoba, C, 5000, Argentina

Location

Universidad Nacional de Cordoba

Córdoba, 5000, Argentina

Location

Related Publications (1)

  • 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.

    PMID: 34384941DERIVED

Study Officials

  • Vilma Campana, Dr

    Departments of Biomedical Physics - University of Cordoba Argentina

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 17, 2019

Study Start

January 2, 2018

Primary Completion

March 22, 2020

Study Completion

March 22, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

AR(2)