Effectiveness of Isometric vs. Eccentric Exercise in Chronic Achilles Tendinopathy

February 9, 2021 updated by: Goran Radovanovic, Humboldt-Universität zu Berlin

Effectiveness of Eccentric Exercise Compared to Isometric Exercise in Athletes With Chronic Achilles Tendinopathy

This is a prospective single blinded randomised controlled trial with a 12-week intervention period and a half-year follow-up period. The main purpose is to determine the effects of isometric exercise on mechanical, morphological and functional tendon properties versus eccentric exercise in chronic Achilles tendinopathy.

Study Overview

Status

Completed

Conditions

Detailed Description

This research project was funded by means of the "Bundesinstitut für Sportwissenschaft" based on a resolution of the German Federal Parliament.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 10117
        • Humboldt Universität zu Berlin, Institut für Bewegungswissenschaften, Department Movement Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Chronic (3 months or more) condition of unilateral Achilles tendinopathy confirmed by a medical doctor based on ultrasound
  • age 18-60
  • male
  • VISA-A Score of at least 80

Exclusion Criteria:

  • bilateral tendinopathy
  • any systemic or inflammatory diseases (i. e. Diabetes, Arthritis)
  • surgery on lower extremities in the past
  • corticoid injections in the last 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Isometric exercise
Isometric exercise (90% maximum voluntary contraction (MVC), 12 weeks, 4 times a week, 5 sets of 4 repetitions a 3 seconds)
Active Comparator: Eccentric exercise
Eccentric training ("Alfredson" approach, 12 weeks, 2 sets per day with extended and two sets per day with bended knee, 15 repetitions per set)
No Intervention: Control
Control, no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphological tendon properties, Tendon cross sectional area (CSA)
Time Frame: At baseline and 12 weeks after

Equipment Magnetic resonance imaging (MRI) (0.25 T MR Scanner (Esaote, G-Scan, Italy), T1-Gewichtung, 3D HYCE (GR) Sequency, TR 10 ms, TE 5 ms, flip angle 80°, layer thickness 3 mm, 1 Anregung) Software OsiriX (Pixmeo SARL, Version 2.5.1., Schweiz)

Tendon thickness / cross sectional area (CSA) in square millimeter (mm²) through MRI, manually outlined via Software OsiriX (Pixmeo SARL, Version 2.5.1., Schweiz). The mean value of three measurements of the same image will be used for analysis. In order to demonstrate local changes within the tendon, CSA will be shown in 10% intervals relative to the total length of the tendon.

At baseline and 12 weeks after
Mechanical tendon properties, Tendon stiffness
Time Frame: At baseline and 12 weeks after

Equipment Dynamometer (Biodex System 3, Medical Systems Inc., USA), optical motion capture system with eight cameras with a frequency of 250 Hertz (Hz) (Vicon Nexus, version 1.7.1., Vicon Motion Systems, UK), electromyography (Myon m320RX, Myon AG, Schweiz) and a linear ultrasound (7.5 Megahertz (MHz), ESAOTE MyLab 60)

Tendon stiffness in Newton per mm (N/mm) with support of tendon force in Newton (N)

At baseline and 12 weeks after
Mechanical tendon properties, Modulus
Time Frame: At baseline and 12 weeks after

Equipment Dynamometer (Biodex System 3, Medical Systems Inc., USA), optical motion capture system with eight cameras with a frequency of 250 Hertz (Hz) (Vicon Nexus, version 1.7.1., Vicon Motion Systems, UK), electromyography (Myon m320RX, Myon AG, Schweiz) and a linear ultrasound (7.5 Megahertz (MHz), ESAOTE MyLab 60)

Modulus in Pascal (Pa) based on tendon stress (Pa) and tendon elongation in millimeter (mm)

At baseline and 12 weeks after
Morphological tendon properties, Tendon length
Time Frame: At baseline and 12 weeks after

Equipment Magnetic resonance imaging (MRI) (0.25 T MR Scanner (Esaote, G-Scan, Italy), T1-Gewichtung, 3D HYCE (GR) Sequency, TR 10 ms, TE 5 ms, flip angle 80°, layer thickness 3 mm, 1 Anregung) Software OsiriX (Pixmeo SARL, Version 2.5.1., Schweiz)

Tendon length im millimeter (mm) through MRI, manually outlined via Software OsiriX (Pixmeo SARL, Version 2.5.1., Schweiz).The mean value of three measurements of the same image will be used for analysis.

At baseline and 12 weeks after
Morphological tendon properties, Tendon vascularization level
Time Frame: At baseline and 12 weeks after

Equipment Linear ultrasound (7.5 Megahertz (MHz), ESAOTE MyLab 60) Software Doppler Flow Image Analyser version 1.01

Vascularization level of the tendon via Color Doppler (CD) ultrasound CD signals will be estimated through the total number of coloured pixels within the area of interest (3x7 centimeters (cm) with the help of Software Doppler Flow Image Analyser version 1.01 (http://www.gtech.dk).

At baseline and 12 weeks after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical functional score
Time Frame: At baseline, 12 weeks and six months after
Victorian Institute of Sport (VISA) - Achilles (A) questionnaire scores from 0 points to 100 points.
At baseline, 12 weeks and six months after
Interleukin 6 level
Time Frame: At baseline and 12 weeks after
Interleukin 6 (IL- 6) detection in the blood plasma is measured in picogram per milliliter (pg/ml) unit.
At baseline and 12 weeks after
Functional tendon properties, Ground contact time
Time Frame: At baseline and 12 weeks after

Drop jumps and counter movement jumps on a three dimensional force plate (AMTI, BP400600-2000, 60x40 cm, 1000 Hz)

Ground contact time is estimated through ground reaction forces (N or kN).

At baseline and 12 weeks after
Functional tendon properties, Maximum jump height
Time Frame: At baseline and 12 weeks after

Drop jumps and counter movement jumps on a three dimensional force plate (AMTI, BP400600-2000, 60x40 cm, 1000 Hz)

Maximum jump height is estimated through the vertical impulse / component of the ground reaction force in Newton (N) or Kilo Newton (kN)

At baseline and 12 weeks after
Pain level via Visual Analogue Scale (VAS)
Time Frame: At baseline, 12 weeks and six months after
A Visual Analogue Scale (VAS) for pain reaching from 0mm to 100mm as part of the VISA - A questionnaire.
At baseline, 12 weeks and six months after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Kirsten Legerlotz, PhD, Prof, Humboldt Universität zu Berlin, Department of Movement Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (Estimate)

April 11, 2016

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tendinopathy

Clinical Trials on Isometric exercise

Subscribe