- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02732782
Effectiveness of Isometric vs. Eccentric Exercise in Chronic Achilles Tendinopathy
Effectiveness of Eccentric Exercise Compared to Isometric Exercise in Athletes With Chronic Achilles Tendinopathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Berlin, Germany, 10117
- Humboldt Universität zu Berlin, Institut für Bewegungswissenschaften, Department Movement Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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)
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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)
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No Intervention: Control
Control, no intervention
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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
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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
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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
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Morphological tendon properties, Tendon length
Time Frame: At baseline and 12 weeks after
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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
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Morphological tendon properties, Tendon vascularization level
Time Frame: At baseline and 12 weeks after
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical functional score
Time Frame: At baseline, 12 weeks and six months after
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Victorian Institute of Sport (VISA) - Achilles (A) questionnaire scores from 0 points to 100 points.
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At baseline, 12 weeks and six months after
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Interleukin 6 level
Time Frame: At baseline and 12 weeks after
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Interleukin 6 (IL- 6) detection in the blood plasma is measured in picogram per milliliter (pg/ml) unit.
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At baseline and 12 weeks after
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Functional tendon properties, Ground contact time
Time Frame: At baseline and 12 weeks after
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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
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Functional tendon properties, Maximum jump height
Time Frame: At baseline and 12 weeks after
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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
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Pain level via Visual Analogue Scale (VAS)
Time Frame: At baseline, 12 weeks and six months after
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A Visual Analogue Scale (VAS) for pain reaching from 0mm to 100mm as part of the VISA - A questionnaire.
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At baseline, 12 weeks and six months after
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Kirsten Legerlotz, PhD, Prof, Humboldt Universität zu Berlin, Department of Movement Sciences
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR020151100167
- AZ: ZMV14-070102/16-17 (Other Grant/Funding Number: Bundesinstitut für Sportwissenschaft (BISp))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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