Achilles Tendon RuptureNCT03861572
Eccentric Training Effects on Functionality and Neuromechanical Properties After Achilles Tendon Surgical Repair
A study testing Isokinetic eccentric training and Traditional eccentric training in people with Achilles Tendon Rupture, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
Early rehabilitation protocols have been studied in Achilles tendon (AT) rupture patients, but deficits in tendon biomechanical properties have been observed several years after the injury. AT rupture patients are unable to return to their previous levels of physical activity. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Isokinetic eccentric training and Traditional eccentric training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Feb 2019to 1 Aug 2022
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants will be male and female subjects who suffered total acute Achilles tendon rupture, and which underwent surgical repair. In addition, to participate in this study all volunteers will need to present medical and/or physiotherapeutic release for physical/sports activities practice.
Who cannot join
- Volunteers that did not have Achilles tendon surgical reconstruction, that did not present medical and/or physiotherapeutic release for physical/sports activities, who have participated in strength training program for the plantar flexors in the last 6 months, patients with diabetic diseases, as well as those with difficulty for understanding and/or executing the test and training protocols in the isokinetic dynamometer will be excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Exercise Research Laboratory, School of Physical Education, Physical Therapy and Dance, Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200
About this study
Official title: Eccentric Training Effects on Functionality and on Triceps Surae Neuromechanical Properties After Achilles Tendon Surgical Repair
Early rehabilitation protocols have been studied in Achilles tendon (AT) rupture patients, but deficits in tendon biomechanical properties have been observed several years after the injury. AT rupture patients are unable to return to their previous levels of physical activity. They present deleterious adaptations in the plantar flexor muscles that lead to functional deficits, and deficits in the tendon's structural and mechanical properties. Eccentric contractions have been suggested to recover these muscle properties. This contraction is known to produce higher force compared to isometric and concentric contractions, and increases tendon stiffness. However, there is a lack of studies showing the effects of the eccentric training in AT rupture rehabilitation. We want to know if an isokinetic eccentric training program will determine the desired adaptations on triceps surae muscle-tendon unit's properties in patients subjected to the AT surgical repair. More specifically, the aim of this study is verifying the effects of a 12-week eccentric training program on triceps surae muscle-tendon unit's properties in subjects that were subjected to the AT surgical repair. 30 subjects will be randomized in two groups: (1) isokinetic eccentric training; and (2) traditional eccentric training control group. All participants will be submitted to a four-week control period, followed by a 12-week period of training for the plantar flexor muscles. Neuromuscular system properties, AT biomechanical properties and functional tests will be evaluated. Participants will be evaluated in four moments: at baseline; after 4, 8 and 12 weeks of rehabilitation. Tendon mechanical (stiffness, stress, strain), material (Young's modulus) and morphological (cross-sectional area and tendon length) properties; muscle architecture (thickness, pennation angle and fascicle length); and functional tests (heel rise resistance and height) will be analyzed between groups and periods. Effects and interactions will be analyzed with ANOVA two-way. Clinical effects will be analyzed using effect size and magnitude-based inferences.
Read the detailed description
Detailed Description: Early rehabilitation protocols have been studied in Achilles tendon (AT) rupture patients, but deficits in tendon biomechanical properties have been observed several years after the injury. AT rupture patients are unable to return to their previous levels of physical activity. They present deleterious adaptations in the plantar flexor muscles that lead to functional deficits and deficits in the tendon structural and mechanical properties. Deficits in calf muscle endurance and strength remained 7 years after the injury. In this regards, eccentric contractions are recommended to recover muscle morphology and mechanical properties. This contraction type produces higher force compared to isometric and concentric contractions, and increases tendon stiffness. However, there is a lack of studies showing the effect of the eccentric training in AT rupture rehabilitation. We want to know if an isokinetic eccentric training program will determine the desired adaptations on triceps surae muscle-tendon unit's properties in patients subjected to the AT surgical repair. More specifically, the aim of this study is verifying the effects of a 12-week eccentric training program on triceps surae muscle-tendon unit's properties in subjects that were subjected to the AT surgical repair. Our hypothesis is that the eccentric training program will (1) increase the ability to produce muscular strength; (2) will produce an increase in gastrocnemius and soleus muscles thickness, fascicle length, and pennation angle; (3) will increase AT stiffness and Young's modulus; (4) will increase ankle functionality; (5) will improve the patient's quality of life. Finally, we expect that the abovementioned changes from isokinetic eccentric training will be greater than those from the traditional eccentric control group that will be subjected to 12 weeks of plantar flexor training with weights. 30 subjects will be randomized in two groups: (1) isokinetic eccentric training; and (2) traditional eccentric training control group. All participants will be submitted to a four-week control period, followed by a 12- week period of training for the plantar flexor muscles. Neuromuscular system properties, AT biomechanical properties and functional tests will be evaluated. Participants will be evaluated in four moments: at baseline; after 4, 8 and 12 weeks of rehabilitation. Tendon mechanical (stiffness, stress, strain), material (Young's modulus) and morphological (cross sectional area and tendon length) properties; muscle architecture (thickness, pennation angle and fascicle length); and functional tests (heel rise resistance and height) will be analyzed between groups and periods. Effects and interactions will be analyzed with ANOVA two- way (group x period). Clinical effects will be analyzed using effect size (Cohen's d) and magnitude-based inferences.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Isokinetic eccentric training, Traditional eccentric training
- Keywords
- Achilles tendon, physical therapy, eccentric training, Achilles tendon rupture, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic eccentric trainingOther
Training sessions will be performed in the same isokinetic dynamometer used in previous evaluations, twice a week, with a minimum interval of 72 hours between sessions.
Traditional eccentric trainingOther
Training sessions will be performed at university gym, twice a week, with a minimum interval of 72 hours between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Isokinetic eccentric group | Experimental | The isokinetic eccentric training will be carried out with the volunteers positioned seated on the dynamometer with the apparent axis of the ankle joint rotation aligned with the dynamometer's axis of rotation. Movement will be executed in the angular velocity of 30°·s-1. Ankle range of motion (ROM) will be standardized for all participants in 50º, which shall respect each individual's maximal dorsiflexion amplitude. The 50° eccentric training ROM will start from each subject's 80% of the maximal dorsiflexion. This procedure will be used to ensure that all subjects perform training on the same plantar flexor muscular length, which should promote the same level of muscular requirement among the participants. This methodology was recently used by GEREMIA and VAZ (2016) study. Receives: Other: Isokinetic eccentric training |
| Traditional eccentric training | Active comparator | Participants will be engaged in an intervention program consisting of 12 weeks of traditional eccentric training. The training will be carried out with the volunteers at gym in stand position. Concentric phase will be realized with both legs and the eccentric one only with one of them. Training progression will be the same from de isokinetic eccentric group. The same periodization from eccentric group will be used to permit us a posteriori comparison between groups. Training sessions will be performed at university gym, twice a week, with a minimum interval of 72 hours between sessions. Each training session will comprise the same specific warming protocol for the ankle joint from the eccentric training. Receives: Other: Traditional eccentric training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon Young's modulus
Tendon elastic modulus (Young's modulus) will be obtained by calculating the slope in the last 40% of the linear region of the stress-strain curve.
Measured: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Tendon stiffness
Tendon stiffness will be obtained by calculating the slope in the last 40% of the linear region of the force-deformation curve.
Measured: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Resistance to plantar flexion test
The number of times, as well as the elevation height, will be used for data analysis. Height will be recorded and will be analyzed with Kinovea software.
Measured: First baseline evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Vertical countermovement jump
Vertical jump will be recorded using cameras and maximal vertical height will be measured using Kinovea software.
Measured: First baseline evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Triple hop test
Maximal distance of a triple unilateral jump will be measure with a metric tape.
Measured: First baseline evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Secondary outcomes (8)
Achilles tendon cross-sectional area
To obtain the Achilles tendon cross-sectional area (CSA), the US probe (GE Healthcare, Waukesha, Washington, USA) will be placed perpendicular to the tendon (in the transverse plane), and 3 images will be obtained with reference to the distances of 2, 4, 6, 8 and 10 cm of the muscle insertion in the calcaneus bone (ARYA and KULIG, 2010). Area values will be obtained for each image, and the final value of the area will be calculated by the average of these five values.
Measured: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Achilles tendon length
To obtain Achilles tendon length, the US (LOGIQ P6, GE Healthcare, Waukesha, Washington, USA) and a linear matrix array transducer (GE Healthcare, Waukesha, Washington, USA) will be placed longitudinally to the tendon (in the sagittal plane). The most distal portion of the Achilles tendon, inserted into the calcaneus bone, will be determined by US, and the respective point will be marked on the skin. After this, the probe will be moved to a proximal position until the visualization of the medial gastrocnemius myotendinous junction (MTJ), which is also marked on the skin. The distance between the two marked points on the skin will be measured with a measuring tape, this distance being considered representative of the tendon length (ARYA and KULIG, 2010; GEREMIA et al., 2015; GEREMIA and VAZ, 2016).
Measured: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Muscle strength
The plantar flexor capacity of force production will be obtained during isometric and isokinetic tests using an isokinetic dynamometer (Biodex System 3 Pro, Biodex Medical Systems, USA). Firstly, the isometric tests will be performed, followed by the concentric and eccentric tests.
Measured: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Muscle Architecture
Muscular architecture will be evaluated with an US system and a linear matrix array probe (GE Healthcare, Waukesha, Washington, USA). Muscle architecture parameters will involve fascicle length, pennation angle and muscle thickness (NARICI, 1999). Echo-intensity of the medial gastrocnemius will also be evaluated. The images will be obtained with the subjects in the ventral decubitus position on a stretcher, with the knees extended and the ankle in neutral position (heel line at a 90° angle with respect to the longitudinal axis of the leg, 0° of plantarflexion). A custom system will be used to secure the ankle in the neutral position. The probe will be positioned longitudinally to the muscle fibers at 30% proximal for medial and lateral gastrocnemius, and 50% for soleus, of the distance between the popliteal fold and the lateral malleolus center (KAWAKAMI et al., 1998).
Measured: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Resistance to plantar flexion test
The number of times, as well as the elevation height, will be used for data analysis.
Measured: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Calf muscle perimetry
To calculate the calf muscles perimetry, the leg length will be determined from the distance between the center of the lateral malleolus and the popliteal fossa at the knee. From the determination of this distance, the value corresponding to 30% of the distance from the articular line of the knee will be calculated for the measurement of the leg perimetry (MIYATANI et al., 2004)
Measured: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Muscle echo-intensity
For the echo-intensity evaluation, the probe will be positioned transversally at the proximal 30% of the lower leg length (AKAGI et al., 2018). Three images will be recorded in the same position of the muscle architecture. Echo-intensity has been associated with force production (CADORE et al., 2012; RECH et al., 2014; AKAGI et al., 2018), an aspect that we want to analyze is if there is some correlation among structural and functional variables
Measured: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Muscle Activation
Gastrocnemius and sóleo muscles electromyography (EMG) signals will be measured through pairs of passive surface electrodes (Ag/AgCl, Meditrace, Kendall, Canada) in bipolar configuration. A reference electrode will be placed on the skin covering the anterior surface of the tibia, according to the procedures proposed by the Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM, 2018). The electrodes will be fixed on the skin and a slight pressure will be applied on them to increase the contact between the electrode gel and the skin. The electrodes placement will respect the recommendations proposed by (SENIAM, 2018).
Measured: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start25 Feb 2019
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
- Investigators
- Marco A Vaz, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861572
- Sponsor's protocol ID
- UFRGS 3.046.049
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2019
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barfod KW, Hansen MS, Holmich P, Troelsen A, Kristensen MT. Efficacy of early controlled motion of the ankle compared with no motion after non-operative treatment of an acute Achilles tendon rupture: study protocol for a randomized controlled trial. Trials. 2016 Nov 29;17(1):564. doi: 10.1186/s13063-016-1697-2.
PubMed 27894329Baroni BM, Geremia JM, Rodrigues R, De Azevedo Franke R, Karamanidis K, Vaz MA. Muscle architecture adaptations to knee extensor eccentric training: rectus femoris vs. vastus lateralis. Muscle Nerve. 2013 Oct;48(4):498-506. doi: 10.1002/mus.23785. Epub 2013 Jul 15.
PubMed 23852989Baroni BM, Rodrigues R, Franke RA, Geremia JM, Rassier DE, Vaz MA. Time course of neuromuscular adaptations to knee extensor eccentric training. Int J Sports Med. 2013 Oct;34(10):904-11. doi: 10.1055/s-0032-1333263. Epub 2013 Mar 22.
PubMed 23526592Batterham AM, Hopkins WG. Making meaningful inferences about magnitudes. Int J Sports Physiol Perform. 2006 Mar;1(1):50-7.
PubMed 19114737BENJAMIN, M.; THEOBALD, P.; SUZUKI, D. et al. The Anatomy of the Achilles Tendon. In: MAFFULLI, N. e ALMEKINDERS, L. C. (Ed.). The Achilles Tendon. London, UK: Springer, 2007. cap. 2,
Brorsson A, Gravare Silbernagel K, Olsson N, Nilsson Helander K. Calf Muscle Performance Deficits Remain 7 Years After an Achilles Tendon Rupture. Am J Sports Med. 2018 Feb;46(2):470-477. doi: 10.1177/0363546517737055. Epub 2017 Oct 25.
PubMed 29068725Brorsson A, Willy RW, Tranberg R, Gravare Silbernagel K. Heel-Rise Height Deficit 1 Year After Achilles Tendon Rupture Relates to Changes in Ankle Biomechanics 6 Years After Injury. Am J Sports Med. 2017 Nov;45(13):3060-3068. doi: 10.1177/0363546517717698. Epub 2017 Aug 7.
PubMed 28783473Chalmers J. Review article: Treatment of Achilles tendon ruptures. J Orthop Surg (Hong Kong). 2000 Jun;8(1):97-99. doi: 10.1177/230949900000800118. No abstract available.
PubMed 12468884COHEN, J. Statistical Power Analysis for the Behavioral Sciences. 2nd. USA: Lawrence Erlbaum Associates, Publishers, 1988.
Duclay J, Martin A, Duclay A, Cometti G, Pousson M. Behavior of fascicles and the myotendinous junction of human medial gastrocnemius following eccentric strength training. Muscle Nerve. 2009 Jun;39(6):819-27. doi: 10.1002/mus.21297.
PubMed 19301364El-Akkawi AI, Joanroy R, Barfod KW, Kallemose T, Kristensen SS, Viberg B. Effect of Early Versus Late Weightbearing in Conservatively Treated Acute Achilles Tendon Rupture: A Meta-Analysis. J Foot Ankle Surg. 2018 Mar-Apr;57(2):346-352. doi: 10.1053/j.jfas.2017.06.006. Epub 2017 Sep 30.
PubMed 28974345Frankewycz B, Krutsch W, Weber J, Ernstberger A, Nerlich M, Pfeifer CG. Rehabilitation of Achilles tendon ruptures: is early functional rehabilitation daily routine? Arch Orthop Trauma Surg. 2017 Mar;137(3):333-340. doi: 10.1007/s00402-017-2627-9. Epub 2017 Jan 17.
PubMed 28097423Frizziero A, Trainito S, Oliva F, Nicoli Aldini N, Masiero S, Maffulli N. The role of eccentric exercise in sport injuries rehabilitation. Br Med Bull. 2014 Jun;110(1):47-75. doi: 10.1093/bmb/ldu006. Epub 2014 Apr 15.
PubMed 24736013Frizziero A, Vittadini F, Fusco A, Giombini A, Masiero S. Efficacy of eccentric exercise in lower limb tendinopathies in athletes. J Sports Med Phys Fitness. 2016 Nov;56(11):1352-1358. Epub 2015 Nov 26.
PubMed 26609968Geremia JM, Bobbert MF, Casa Nova M, Ott RD, Lemos Fde A, Lupion Rde O, Frasson VB, Vaz MA. The structural and mechanical properties of the Achilles tendon 2 years after surgical repair. Clin Biomech (Bristol). 2015 Jun;30(5):485-92. doi: 10.1016/j.clinbiomech.2015.03.005. Epub 2015 Mar 11.
PubMed 25828432
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Training Effects on Functionality and on Triceps Surae Neuromechanical Properties After Achilles Tendon Surgical Repair
- ClinicalTrials.gov ID
- NCT03861572
- Acronym / sponsor ID
- UFRGS 3.046.049
- Conditions
- Achilles Tendon Rupture
- Keywords
- Achilles tendon, physical therapy, eccentric training, Achilles tendon rupture, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early rehabilitation protocols have been studied in Achilles tendon (AT) rupture patients, but deficits in tendon biomechanical properties have been observed several years after the injury. AT rupture patients are unable to return to their previous levels of physical activity. They present deleterious adaptations in the plantar flexor muscles that lead to functional deficits, and deficits in the tendon's structural and mechanical properties. Eccentric contractions have been suggested to recover these muscle properties. This contraction is known to produce higher force compared to isometric and concentric contractions, and increases tendon stiffness. However, there is a lack of studies showing the effects of the eccentric training in AT rupture rehabilitation. We want to know if an isokinetic eccentric training program will determine the desired adaptations on triceps surae muscle-tendon unit's properties in patients subjected to the AT surgical repair. More specifically, the aim of this study is verifying the effects of a 12-week eccentric training program on triceps surae muscle-tendon unit's properties in subjects that were subjected to the AT surgical repair. 30 subjects will be randomized in two groups: (1) isokinetic eccentric training; and (2) traditional eccentric training control group. All participants will be submitted to a four-week control period, followed by a 12-week period of training for the plantar flexor muscles. Neuromuscular system properties, AT biomechanical properties and functional tests will be evaluated. Participants will be evaluated in four moments: at baseline; after 4, 8 and 12 weeks of rehabilitation. Tendon mechanical (stiffness, stress, strain), material (Young's modulus) and morphological (cross-sectional area and tendon length) properties; muscle architecture (thickness, pennation angle and fascicle length); and functional tests (heel rise resistance and height) will be analyzed between groups and periods. Effects and interactions will be analyzed with ANOVA two-way. Clinical effects will be analyzed using effect size and magnitude-based inferences.
Detailed description
Detailed Description: Early rehabilitation protocols have been studied in Achilles tendon (AT) rupture patients, but deficits in tendon biomechanical properties have been observed several years after the injury. AT rupture patients are unable to return to their previous levels of physical activity. They present deleterious adaptations in the plantar flexor muscles that lead to functional deficits and deficits in the tendon structural and mechanical properties. Deficits in calf muscle endurance and strength remained 7 years after the injury. In this regards, eccentric contractions are recommended to recover muscle morphology and mechanical properties. This contraction type produces higher force compared to isometric and concentric contractions, and increases tendon stiffness. However, there is a lack of studies showing the effect of the eccentric training in AT rupture rehabilitation. We want to know if an isokinetic eccentric training program will determine the desired adaptations on triceps surae muscle-tendon unit's properties in patients subjected to the AT surgical repair. More specifically, the aim of this study is verifying the effects of a 12-week eccentric training program on triceps surae muscle-tendon unit's properties in subjects that were subjected to the AT surgical repair. Our hypothesis is that the eccentric training program will (1) increase the ability to produce muscular strength; (2) will produce an increase in gastrocnemius and soleus muscles thickness, fascicle length, and pennation angle; (3) will increase AT stiffness and Young's modulus; (4) will increase ankle functionality; (5) will improve the patient's quality of life. Finally, we expect that the abovementioned changes from isokinetic eccentric training will be greater than those from the traditional eccentric control group that will be subjected to 12 weeks of plantar flexor training with weights. 30 subjects will be randomized in two groups: (1) isokinetic eccentric training; and (2) traditional eccentric training control group. All participants will be submitted to a four-week control period, followed by a 12- week period of training for the plantar flexor muscles. Neuromuscular system properties, AT biomechanical properties and functional tests will be evaluated. Participants will be evaluated in four moments: at baseline; after 4, 8 and 12 weeks of rehabilitation. Tendon mechanical (stiffness, stress, strain), material (Young's modulus) and morphological (cross sectional area and tendon length) properties; muscle architecture (thickness, pennation angle and fascicle length); and functional tests (heel rise resistance and height) will be analyzed between groups and periods. Effects and interactions will be analyzed with ANOVA two- way (group x period). Clinical effects will be analyzed using effect size (Cohen's d) and magnitude-based inferences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isokinetic eccentric group | Experimental | Other: Isokinetic eccentric trainingThe isokinetic eccentric training will be carried out with the volunteers positioned seated on the dynamometer with the apparent axis of the ankle joint rotation aligned with the dynamometer's axis of rotation. Movement will be executed in the angular velocity of 30°·s-1. Ankle range of motion (ROM) will be standardized for all participants in 50º, which shall respect each individual's maximal dorsiflexion amplitude. The 50° eccentric training ROM will start from each subject's 80% of the maximal dorsiflexion. This procedure will be used to ensure that all subjects perform training on the same plantar flexor muscular length, which should promote the same level of muscular requirement among the participants. This methodology was recently used by GEREMIA and VAZ (2016) study. |
| Traditional eccentric training | Active comparator | Other: Traditional eccentric trainingParticipants will be engaged in an intervention program consisting of 12 weeks of traditional eccentric training. The training will be carried out with the volunteers at gym in stand position. Concentric phase will be realized with both legs and the eccentric one only with one of them. Training progression will be the same from de isokinetic eccentric group. The same periodization from eccentric group will be used to permit us a posteriori comparison between groups. Training sessions will be performed at university gym, twice a week, with a minimum interval of 72 hours between sessions. Each training session will comprise the same specific warming protocol for the ankle joint from the eccentric training. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants will be male and female subjects who suffered total acute Achilles tendon rupture, and which underwent surgical repair. In addition, to participate in this study all volunteers will need to present medical and/or physiotherapeutic release for physical/sports activities practice.
Key exclusion criteria (1 listed)
- Volunteers that did not have Achilles tendon surgical reconstruction, that did not present medical and/or physiotherapeutic release for physical/sports activities, who have participated in strength training program for the plantar flexors in the last 6 months, patients with diabetic diseases, as well as those with difficulty for understanding and/or executing the test and training protocols in the isokinetic dynamometer will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isokinetic eccentric trainingTraining sessions will be performed in the same isokinetic dynamometer used in previous evaluations, twice a week, with a minimum interval of 72 hours between sessions. | Other | Isokinetic eccentric group |
| Traditional eccentric trainingTraining sessions will be performed at university gym, twice a week, with a minimum interval of 72 hours between sessions. | Other | Traditional eccentric training |
Primary outcome
Tendon Young's modulus
Time frame: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Tendon elastic modulus (Young's modulus) will be obtained by calculating the slope in the last 40% of the linear region of the stress-strain curve.
Tendon stiffness
Time frame: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Tendon stiffness will be obtained by calculating the slope in the last 40% of the linear region of the force-deformation curve.
Resistance to plantar flexion test
Time frame: First baseline evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
The number of times, as well as the elevation height, will be used for data analysis. Height will be recorded and will be analyzed with Kinovea software.
Vertical countermovement jump
Time frame: First baseline evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Vertical jump will be recorded using cameras and maximal vertical height will be measured using Kinovea software.
Triple hop test
Time frame: First baseline evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Maximal distance of a triple unilateral jump will be measure with a metric tape.
8 secondary outcomes
Achilles tendon cross-sectional area
Time frame: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Achilles tendon length
Time frame: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Muscle strength
Time frame: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Muscle Architecture
Time frame: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Resistance to plantar flexion test
Time frame: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Calf muscle perimetry
Time frame: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Muscle echo-intensity
Time frame: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Muscle Activation
Time frame: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Background: PubMed 27894329Barfod KW, Hansen MS, Holmich P, Troelsen A, Kristensen MT. Efficacy of early controlled motion of the ankle compared with no motion after non-operative treatment of an acute Achilles tendon rupture: study protocol for a randomized controlled trial. Trials. 2016 Nov 29;17(1):564. doi: 10.1186/s13063-016-1697-2.
- Background: PubMed 23852989Baroni BM, Geremia JM, Rodrigues R, De Azevedo Franke R, Karamanidis K, Vaz MA. Muscle architecture adaptations to knee extensor eccentric training: rectus femoris vs. vastus lateralis. Muscle Nerve. 2013 Oct;48(4):498-506. doi: 10.1002/mus.23785. Epub 2013 Jul 15.
- Background: PubMed 23526592Baroni BM, Rodrigues R, Franke RA, Geremia JM, Rassier DE, Vaz MA. Time course of neuromuscular adaptations to knee extensor eccentric training. Int J Sports Med. 2013 Oct;34(10):904-11. doi: 10.1055/s-0032-1333263. Epub 2013 Mar 22.
- Background: PubMed 19114737Batterham AM, Hopkins WG. Making meaningful inferences about magnitudes. Int J Sports Physiol Perform. 2006 Mar;1(1):50-7.
- BackgroundBENJAMIN, M.; THEOBALD, P.; SUZUKI, D. et al. The Anatomy of the Achilles Tendon. In: MAFFULLI, N. e ALMEKINDERS, L. C. (Ed.). The Achilles Tendon. London, UK: Springer, 2007. cap. 2,
- Background: PubMed 29068725Brorsson A, Gravare Silbernagel K, Olsson N, Nilsson Helander K. Calf Muscle Performance Deficits Remain 7 Years After an Achilles Tendon Rupture. Am J Sports Med. 2018 Feb;46(2):470-477. doi: 10.1177/0363546517737055. Epub 2017 Oct 25.
- Background: PubMed 28783473Brorsson A, Willy RW, Tranberg R, Gravare Silbernagel K. Heel-Rise Height Deficit 1 Year After Achilles Tendon Rupture Relates to Changes in Ankle Biomechanics 6 Years After Injury. Am J Sports Med. 2017 Nov;45(13):3060-3068. doi: 10.1177/0363546517717698. Epub 2017 Aug 7.
- Background: PubMed 12468884Chalmers J. Review article: Treatment of Achilles tendon ruptures. J Orthop Surg (Hong Kong). 2000 Jun;8(1):97-99. doi: 10.1177/230949900000800118. No abstract available.
- BackgroundCOHEN, J. Statistical Power Analysis for the Behavioral Sciences. 2nd. USA: Lawrence Erlbaum Associates, Publishers, 1988.
- Background: PubMed 19301364Duclay J, Martin A, Duclay A, Cometti G, Pousson M. Behavior of fascicles and the myotendinous junction of human medial gastrocnemius following eccentric strength training. Muscle Nerve. 2009 Jun;39(6):819-27. doi: 10.1002/mus.21297.
- Background: PubMed 28974345El-Akkawi AI, Joanroy R, Barfod KW, Kallemose T, Kristensen SS, Viberg B. Effect of Early Versus Late Weightbearing in Conservatively Treated Acute Achilles Tendon Rupture: A Meta-Analysis. J Foot Ankle Surg. 2018 Mar-Apr;57(2):346-352. doi: 10.1053/j.jfas.2017.06.006. Epub 2017 Sep 30.
- Background: PubMed 28097423Frankewycz B, Krutsch W, Weber J, Ernstberger A, Nerlich M, Pfeifer CG. Rehabilitation of Achilles tendon ruptures: is early functional rehabilitation daily routine? Arch Orthop Trauma Surg. 2017 Mar;137(3):333-340. doi: 10.1007/s00402-017-2627-9. Epub 2017 Jan 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco A Vaz, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isokinetic eccentric training and Traditional eccentric training in people with Achilles Tendon Rupture, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 1 inclusion and 1 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 29 Mar 2024. 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 Brazil. 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?
Tendon Young's modulus (time frame: First evaluation, change from baseline to 4 weeks of training, change from baseline to 8 weeks of training and change from baseline to 12 weeks of training). 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 NCT03861572, which also lists 38 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 29 Mar 2024.