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Effectiveness of Isometric vs. Eccentric Exercise in Chronic Achilles Tendinopathy

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ClinicalTrials.gov Identifier: NCT02732782
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : February 10, 2021
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Goran Radovanovic, 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.

Condition or disease Intervention/treatment Phase
Tendinopathy Other: Isometric exercise Other: Eccentric exercise Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Eccentric Exercise Compared to Isometric Exercise in Athletes With Chronic Achilles Tendinopathy
Study Start Date : August 2016
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


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)
Other: Isometric exercise
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)
Other: Eccentric exercise
No Intervention: Control
Control, no intervention



Primary Outcome Measures :
  1. 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.


  2. 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)


  3. 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)


  4. 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.


  5. 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 Outcome Measures :
  1. Clinical functional score [ Time Frame: At baseline, 12 weeks and six months after ]
    Victorian Institute of Sport (VISA) - Achilles (A) questionnaire scores from 0 points to 100 points.

  2. Interleukin 6 level [ Time Frame: At baseline and 12 weeks after ]
    Interleukin 6 (IL- 6) detection in the blood plasma is measured in picogram per milliliter (pg/ml) unit.

  3. Functional tendon properties, Ground contact time [ Time Frame: 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).


  4. Functional tendon properties, Maximum jump height [ Time Frame: 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)


  5. Pain level via Visual Analogue Scale (VAS) [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732782


Locations
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Germany
Humboldt Universität zu Berlin, Institut für Bewegungswissenschaften, Department Movement Sciences
Berlin, Germany, 10117
Sponsors and Collaborators
Humboldt-Universität zu Berlin
Charite University, Berlin, Germany
Investigators
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Study Director: Kirsten Legerlotz, PhD, Prof Humboldt Universität zu Berlin, Department of Movement Sciences
Publications:
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Responsible Party: Goran Radovanovic, Principal Investigator, Humboldt-Universität zu Berlin
ClinicalTrials.gov Identifier: NCT02732782    
Other Study ID Numbers: PR020151100167
AZ: ZMV14-070102/16-17 ( Other Grant/Funding Number: Bundesinstitut für Sportwissenschaft (BISp) )
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Goran Radovanovic, Humboldt-Universität zu Berlin:
Achilles tendon
isometric muscle training
competitive sports
strength training
eccentric exercise
isometric exercise
chronic condition
regeneration
tendon
tendon properties
tendinopathy
tendinosis
intervention
training load
high performance sports
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries