Effectiveness of Isometric vs. Eccentric Exercise in Chronic Achilles Tendinopathy

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732782
• Other study ID #: PR020151100167
• Secondary ID: AZ: ZMV14-070102
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: October 30, 2020

Study information

• Verified date: February 2021
• Source: Humboldt-Universität zu Berlin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 30, 2020
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Other:
• Isometric exercise

• Eccentric exercise

Locations

Country	Name	City	State
Germany	Humboldt Universität zu Berlin, Institut für Bewegungswissenschaften, Department Movement Sciences	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Humboldt-Universität zu Berlin	Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Arampatzis A, Karamanidis K, Mademli L, Albracht K. Plasticity of the human tendon to short- and long-term mechanical loading. Exerc Sport Sci Rev. 2009 Apr;37(2):66-72. doi: 10.1097/JES.0b013e31819c2e1d. Review. — View Citation

Legerlotz K, Jones ER, Screen HR, Riley GP. Increased expression of IL-6 family members in tendon pathology. Rheumatology (Oxford). 2012 Jul;51(7):1161-5. doi: 10.1093/rheumatology/kes002. Epub 2012 Feb 15. — View Citation

Mersmann F, Bohm S, Schroll A, Boeth H, Duda GN, Arampatzis A. Muscle and tendon adaptation in adolescent athletes: A longitudinal study. Scand J Med Sci Sports. 2017 Jan;27(1):75-82. doi: 10.1111/sms.12631. Epub 2015 Dec 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphological tendon properties, Tendon cross sectional area (CSA)	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
Primary	Mechanical tendon properties, Tendon stiffness	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
Primary	Mechanical tendon properties, Modulus	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
Primary	Morphological tendon properties, Tendon length	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
Primary	Morphological tendon properties, Tendon vascularization level	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	Clinical functional score	Victorian Institute of Sport (VISA) - Achilles (A) questionnaire scores from 0 points to 100 points.	At baseline, 12 weeks and six months after
Secondary	Interleukin 6 level	Interleukin 6 (IL- 6) detection in the blood plasma is measured in picogram per milliliter (pg/ml) unit.	At baseline and 12 weeks after
Secondary	Functional tendon properties, Ground contact time	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
Secondary	Functional tendon properties, Maximum jump height	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
Secondary	Pain level via Visual Analogue Scale (VAS)	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