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TendinopathyNCT02732782

Effectiveness of Isometric vs. Eccentric Exercise in Chronic Achilles Tendinopathy

A study testing Isometric exercise and Eccentric exercise in people with Tendinopathy, run by Humboldt-Universität zu Berlin at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 20 to 50 years, men only
Conditions the study is for
Tendinopathy
What is being tested?
Isometric exercise and Eccentric exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteGermany
Study dates
Aug 2016to 30 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Berlin, 10117

Other trials in Germany

About this study

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

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.

Read the detailed description

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

Conditions
Tendinopathy
Being tested
Isometric exercise, Eccentric exercise
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
Medical subject headings
Tendinopathy, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isometric exerciseOther

  • Eccentric exerciseOther

Study groups in NCT02732782
Study groupRoleWhat they receive
Isometric exerciseExperimentalIsometric exercise (90% maximum voluntary contraction (MVC), 12 weeks, 4 times a week, 5 sets of 4 repetitions a 3 seconds)
Receives: Other: Isometric exercise
Eccentric exerciseActive comparatorEccentric training ("Alfredson" approach, 12 weeks, 2 sets per day with extended and two sets per day with bended knee, 15 repetitions per set)
Receives: Other: Eccentric exercise
ControlNo interventionControl, no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline and 12 weeks after

  2. 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)

    Measured: At baseline and 12 weeks after

  3. 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)

    Measured: At baseline and 12 weeks after

  4. 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.

    Measured: At baseline and 12 weeks after

  5. 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).

    Measured: At baseline and 12 weeks after

Secondary outcomes (5)

  1. Clinical functional score

    Victorian Institute of Sport (VISA) - Achilles (A) questionnaire scores from 0 points to 100 points.

    Measured: At baseline, 12 weeks and six months after

  2. Interleukin 6 level

    Interleukin 6 (IL- 6) detection in the blood plasma is measured in picogram per milliliter (pg/ml) unit.

    Measured: At baseline and 12 weeks after

  3. 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).

    Measured: At baseline and 12 weeks after

  4. 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)

    Measured: At baseline and 12 weeks after

  5. 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.

    Measured: At baseline, 12 weeks and six months after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion28 Feb 2019
  4. Study completion30 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02732782
Sponsor's protocol ID
PR020151100167
Other IDs
AZ: ZMV14-070102/16-17
Status last verified
Feb 2021
First submitted
22 Mar 2016
Last updated
10 Feb 2021
Results posted
No
Individual data sharing
Undecided

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.

    PubMed 22337942

  • 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.

    PubMed 26644277

  • 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.

    PubMed 19305197

  • 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.

    PubMed 36538166

Questions about this trial

What is this clinical trial studying?

A study testing Isometric exercise and Eccentric exercise in people with Tendinopathy, run by Humboldt-Universität zu Berlin at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morphological tendon properties, Tendon cross sectional area (CSA) (time frame: At baseline and 12 weeks after). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02732782, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.

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