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| ID | Type | Description | Link |
|---|---|---|---|
| AZ: ZMV14-070102/16-17 | Other Grant/Funding Number | Bundesinstitut für Sportwissenschaft (BISp) |
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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
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.
This research project was funded by means of the "Bundesinstitut für Sportwissenschaft" based on a resolution of the German Federal Parliament.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isometric exercise | Experimental | Isometric exercise (90% maximum voluntary contraction (MVC), 12 weeks, 4 times a week, 5 sets of 4 repetitions a 3 seconds) |
|
| Eccentric exercise | Active Comparator | Eccentric training ("Alfredson" approach, 12 weeks, 2 sets per day with extended and two sets per day with bended knee, 15 repetitions per set) |
|
| Control | No Intervention | Control, no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isometric exercise | Other |
| ||
| Eccentric exercise |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Interleukin 6 level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten Legerlotz, PhD, Prof | Humboldt Universität zu Berlin, Department of Movement Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humboldt Universität zu Berlin, Institut für Bewegungswissenschaften, Department Movement Sciences | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22337942 | Background | 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. | |
| 26644277 | Background | 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. |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| At baseline and 12 weeks after |
| 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 |
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 | 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 | 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) | 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 |
| 19305197 | Background | 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. |
| 36538166 | Derived | Radovanovic G, Bohm S, Peper KK, Arampatzis A, Legerlotz K. Evidence-Based High-Loading Tendon Exercise for 12 Weeks Leads to Increased Tendon Stiffness and Cross-Sectional Area in Achilles Tendinopathy: A Controlled Clinical Trial. Sports Med Open. 2022 Dec 20;8(1):149. doi: 10.1186/s40798-022-00545-5. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |