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Effectiveness of Isometric vs. Eccentric Exercise in Chronic Achilles Tendinopathy

Primary Purpose

Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Isometric exercise
Eccentric exercise
Sponsored by
Humboldt-Universität zu Berlin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring 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

Eligibility Criteria

20 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Humboldt Universität zu Berlin, Institut für Bewegungswissenschaften, Department Movement Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Isometric exercise

Eccentric exercise

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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)
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)
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.
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).

Secondary Outcome Measures

Clinical functional score
Victorian Institute of Sport (VISA) - Achilles (A) questionnaire scores from 0 points to 100 points.
Interleukin 6 level
Interleukin 6 (IL- 6) detection in the blood plasma is measured in picogram per milliliter (pg/ml) unit.
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).
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)
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.

Full Information

First Posted
March 22, 2016
Last Updated
February 9, 2021
Sponsor
Humboldt-Universität zu Berlin
Collaborators
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02732782
Brief Title
Effectiveness of Isometric vs. Eccentric Exercise in Chronic Achilles Tendinopathy
Official Title
Effectiveness of Eccentric Exercise Compared to Isometric Exercise in Athletes With Chronic Achilles Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Humboldt-Universität zu Berlin
Collaborators
Charite University, Berlin, Germany

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isometric exercise
Arm Type
Experimental
Arm Description
Isometric exercise (90% maximum voluntary contraction (MVC), 12 weeks, 4 times a week, 5 sets of 4 repetitions a 3 seconds)
Arm Title
Eccentric exercise
Arm Type
Active Comparator
Arm Description
Eccentric training ("Alfredson" approach, 12 weeks, 2 sets per day with extended and two sets per day with bended knee, 15 repetitions per set)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control, no intervention
Intervention Type
Other
Intervention Name(s)
Isometric exercise
Intervention Type
Other
Intervention Name(s)
Eccentric exercise
Primary Outcome Measure Information:
Title
Morphological tendon properties, Tendon cross sectional area (CSA)
Description
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.
Time Frame
At baseline and 12 weeks after
Title
Mechanical tendon properties, Tendon stiffness
Description
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)
Time Frame
At baseline and 12 weeks after
Title
Mechanical tendon properties, Modulus
Description
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)
Time Frame
At baseline and 12 weeks after
Title
Morphological tendon properties, Tendon length
Description
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.
Time Frame
At baseline and 12 weeks after
Title
Morphological tendon properties, Tendon vascularization level
Description
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).
Time Frame
At baseline and 12 weeks after
Secondary Outcome Measure Information:
Title
Clinical functional score
Description
Victorian Institute of Sport (VISA) - Achilles (A) questionnaire scores from 0 points to 100 points.
Time Frame
At baseline, 12 weeks and six months after
Title
Interleukin 6 level
Description
Interleukin 6 (IL- 6) detection in the blood plasma is measured in picogram per milliliter (pg/ml) unit.
Time Frame
At baseline and 12 weeks after
Title
Functional tendon properties, Ground contact time
Description
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).
Time Frame
At baseline and 12 weeks after
Title
Functional tendon properties, Maximum jump height
Description
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)
Time Frame
At baseline and 12 weeks after
Title
Pain level via Visual Analogue Scale (VAS)
Description
A Visual Analogue Scale (VAS) for pain reaching from 0mm to 100mm as part of the VISA - A questionnaire.
Time Frame
At baseline, 12 weeks and six months after

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Legerlotz, PhD, Prof
Organizational Affiliation
Humboldt Universität zu Berlin, Department of Movement Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Humboldt Universität zu Berlin, Institut für Bewegungswissenschaften, Department Movement Sciences
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22337942
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.
Results Reference
background
PubMed Identifier
26644277
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.
Results Reference
background
PubMed Identifier
19305197
Citation
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.
Results Reference
background

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Effectiveness of Isometric vs. Eccentric Exercise in Chronic Achilles Tendinopathy

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