Effectiveness of Isometric vs. Eccentric Exercise in Chronic Achilles Tendinopathy

NCT02732782 | Completed

• 2 other identifiers: PR020151100167AZ: ZMV14-070102/16-17
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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

Secondary Outcomes (5)

• Clinical functional score

  At baseline, 12 weeks and six months after

• Interleukin 6 level

  At baseline and 12 weeks after

• Functional tendon properties, Ground contact time

  At baseline and 12 weeks after

• Functional tendon properties, Maximum jump height

  At baseline and 12 weeks after

• Pain level via Visual Analogue Scale (VAS)

  At baseline, 12 weeks and six months after

Study Arms (3)

Isometric exercise

EXPERIMENTAL

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

Other: Isometric exercise

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)

Other: Eccentric exercise

Control

NO INTERVENTION

Control, no intervention

Interventions

Isometric exercise OTHER

Isometric exercise

Eccentric exercise OTHER

Eccentric exercise

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Humboldt-Universität zu Berlin: lead
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

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

Berlin, 10117, Germany

Location

Related Publications (4)

• 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.

  PMID: 22337942 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.

  PMID: 26644277 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.

  PMID: 19305197 BACKGROUND

• 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.

  PMID: 36538166 DERIVED

MeSH Terms

Conditions

Tendinopathy; Chronic Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kirsten Legerlotz, PhD, Prof

  Humboldt Universität zu Berlin, Department of Movement Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 11, 2016
• Study Start: August 1, 2016
• Primary Completion: February 28, 2019
• Study Completion: October 30, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

DE (1)