NCT03861572

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

3.3 years

First QC Date

February 25, 2019

Last Update Submit

March 27, 2024

Conditions

Keywords

Achilles tendonphysical therapyeccentric trainingAchilles tendon rupturerehabilitation

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    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

    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

    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

    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

    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

    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

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Other: Traditional eccentric training

Interventions

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.

Isokinetic eccentric group

Training sessions will be performed at university gym, twice a week, with a minimum interval of 72 hours between sessions.

Traditional eccentric training

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, Brazil

Location

Related Publications (38)

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Study Officials

  • Marco A Vaz, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Raters will be blinded to the participants' allocation in each group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 4, 2019

Study Start

February 25, 2019

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

March 29, 2024

Record last verified: 2024-03

Locations