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Clinical Trials/NCT02732782
NCT02732782
Completed
N/A

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

Humboldt-Universität zu Berlin1 site in 1 country45 target enrollmentAugust 2016
ConditionsTendinopathy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tendinopathy
Sponsor
Humboldt-Universität zu Berlin
Enrollment
45
Locations
1
Primary Endpoint
Morphological tendon properties, Tendon cross sectional area (CSA)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
October 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Goran Radovanovic

Principal Investigator

Humboldt-Universität zu Berlin

Eligibility Criteria

Inclusion Criteria

  • Chronic (3 months or more) condition of unilateral Achilles tendinopathy confirmed by a medical doctor based on ultrasound
  • age 18-60
  • 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

Outcomes

Primary Outcomes

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.

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)

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)

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.

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).

Secondary Outcomes

  • Clinical functional score(At baseline, 12 weeks and six months after)
  • Interleukin 6 level(At baseline and 12 weeks after)
  • Functional tendon properties, Ground contact time(At baseline and 12 weeks after)
  • Functional tendon properties, Maximum jump height(At baseline and 12 weeks after)
  • Pain level via Visual Analogue Scale (VAS)(At baseline, 12 weeks and six months after)

Study Sites (1)

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