Effectiveness of Isometric vs. Eccentric Exercise in Chronic Achilles Tendinopathy

Not Applicable

Completed

• Conditions: Tendinopathy
• Interventions: Other: Isometric exercise; Other: Eccentric exercise

• Registration Number: NCT02732782
• Lead Sponsor: Humboldt-Universität zu Berlin

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.

Study Timeline

• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-11
• Study Start: 2016-08
• Primary Completion: 2019-02-28
• Study Completion: 2020-10-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isometric exercise	Isometric exercise	Isometric exercise (90% maximum voluntary contraction (MVC), 12 weeks, 4 times a week, 5 sets of 4 repetitions a 3 seconds)
Eccentric exercise	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)

Primary Outcome Measures

Name	Time	Method
Morphological tendon properties, Tendon cross sectional area (CSA)	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	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	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	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	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 Outcome Measures

Name	Time	Method
Clinical functional score	At baseline, 12 weeks and six months after	Victorian Institute of Sport (VISA) - Achilles (A) questionnaire scores from 0 points to 100 points.
Interleukin 6 level	At baseline and 12 weeks after	Interleukin 6 (IL- 6) detection in the blood plasma is measured in picogram per milliliter (pg/ml) unit.
Functional tendon properties, Ground contact time	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).
Functional tendon properties, Maximum jump height	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)
Pain level via Visual Analogue Scale (VAS)	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.

Trial Locations

Locations (1)

Humboldt Universität zu Berlin, Institut für Bewegungswissenschaften, Department Movement Sciences; 🇩🇪 Berlin, Germany