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Clinical Trials/NCT06912269
NCT06912269RecruitingNot Applicable

Effects of Strength Training at Different Intensities on the Plantar Flexors' Functional, Neuromuscular, and Tendon Properties After Achilles Tendon Rupture

Federal University of Rio Grande do Sul1 site in 1 country67 target enrollmentStarted: October 10, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
67
Locations
1
Primary Endpoint
Changes in foot and ankle joint function

Study Overview

Brief Summary

Among the injuries that affect the Achilles tendon, rupture is one of the most frequent. This injury can generate functional, neuromuscular, and tendon deficits that can last for long periods or even be permanent. In the long term (i.e., more than a year after the injury), individuals present functional impairments related to the lower limb, deficits in the capacity to produce muscle force, as well as higher levels of muscle activation (as a compensatory response). Such changes may be due to injury adaptations in the plantar flexor muscles' architecture, which may have shorter, more pennate fibers, leading to reduced muscle thickness. Furthermore, the Achilles tendon may be elongated, with a greater cross-sectional area, presenting lower stiffness and quality (i.e., lower Young's modulus). Strength training can play an important role in recovering from Achilles tendon ruptures, as it promotes functional, neuromuscular, and tendon adaptations that can minimize deficits caused by the injury. However, there is a gap in the literature regarding strength training, as well as the dose vs response relationship, regarding functional, neuromuscular, and tendon adaptations after Achilles tendon rupture. Thus, the aim of the present study is to compare the effects of a strength training program of different intensities on plantar flexors' functional, neuromuscular, and tendon outcomes after Achilles tendon rupture. Men aged between 20 and 50 years old who suffered a total unilateral rupture of the Achilles tendon between one and five years after the rupture will be included in the study, as well as healthy men who did not suffer the rupture (control group). Participants who have suffered an Achilles tendon rupture will undergo a progressive lower limb strength training program twice a week for a total duration of 12 weeks, which will be randomized between two groups: low intensity (G55 - 55% of 1-RM) and moderate intensity (G70 - 70% of 1-RM). The following outcomes will be evaluated: a) Achilles tendon's morphological (length and cross-sectional area), mechanical (force-elongation relationship and stiffness) and material (stress-strain relationship and Young's modulus) properties; b) triceps surae muscles' morphological (architecture [fascicle length, pennation angle and thickness] and quality [measured by echointensity and specific tension]) properties; c) ankle functionality (maximum height in the heel raise test); d) the plantar flexors' force production capacity (peak and rate of torque development in different joint positions); e) the plantar flexors' muscle voluntary activation; and f) triceps suraes' neuromuscular capacity (i.e., recruitment curves). Assessments will be performed at two times (pre-training; and after 12 weeks of training [post-12]) through functional tests, ultrasound techniques, isokinetic dynamometry, electromyography, and percutaneous electrical stimulation. An intraclass correlation coefficient will be used to verify the test-retest reproducibility of ultrasound measurements. The Chi-Square test will be used to compare the level of physical activity (pre-training) between the groups. The results of the intervention will be expressed using descriptive statistics (mean, standard deviation, and standard error). The normality and sphericity of the data will be tested using the Shapiro-Wilk and Mauchly tests, respectively. A generalized estimating equation, followed by Bonferroni post-hoc, will be used to compare the effects of groups (G55 and G70) and times (pre-training, Post-6, and Post-12). A one-way ANOVA, followed by a Bonferroni post-hoc, will be used to compare the control group participants' limbs with the healthy and injured limbs from both intervention groups (G55 and G70) in the Pre and Post-12 times. The effect size will be estimated for each outcome. All statistical analyzes will be performed using SPSS software.

Detailed Description

Among the injuries that affect the Achilles tendon, rupture is one of the most frequent. This injury can generate functional, neuromuscular, and tendon deficits that can last for long periods or even be permanent. In the long term (i.e., more than a year after the injury), individuals present functional impairments related to the lower limb, deficits in the capacity to produce muscle force, as well as higher levels of muscle activation (as a compensatory response). Such changes may be due to injury adaptations in the plantar flexor muscles' architecture, which may have shorter, more pennate fibers, leading to reduced muscle thickness. Furthermore, the Achilles tendon may be elongated, with a greater cross-sectional area, presenting lower stiffness and quality (i.e., lower Young's modulus). Strength training can play an important role in recovering from Achilles tendon ruptures, as it promotes functional, neuromuscular, and tendon adaptations that can minimize deficits caused by the injury. However, there is a gap in the literature regarding strength training, as well as the dose vs response relationship, regarding functional, neuromuscular, and tendon adaptations after Achilles tendon rupture. Thus, the aim of the present study is to compare the effects of a strength training program of different intensities on plantar flexors' functional, neuromuscular, and tendon outcomes after Achilles tendon rupture. Men aged between 20 and 50 years old who suffered a total unilateral rupture of the Achilles tendon between one and five years after the rupture will be included in the study, as well as healthy men who did not suffer the rupture (control group). Participants who have suffered an Achilles tendon rupture will undergo a progressive lower limb strength training program twice a week for a total duration of 12 weeks, which will be randomized between two groups: low intensity (G55 - 55% of 1-RM) and moderate intensity (G70 - 70% of 1-RM). The following outcomes will be evaluated: a) Achilles tendon's morphological (length and cross-sectional area), mechanical (force-elongation relationship and stiffness) and material (stress-strain relationship and Young's modulus) properties; b) triceps surae muscles' morphological (architecture [fascicle length, pennation angle and thickness] and quality [measured by echointensity and specific tension]) properties; c) ankle functionality (maximum height in the heel raise test); d) the plantar flexors' force production capacity (peak and rate of torque development in different joint positions); e) the plantar flexors' muscle voluntary activation; and f) triceps suraes' neuromuscular capacity (i.e., recruitment curves). Assessments will be performed at two times (pre-training; and after 12 weeks of training [post-12]) through functional tests, ultrasound techniques, isokinetic dynamometry, electromyography, and percutaneous electrical stimulation. An intraclass correlation coefficient will be used to verify the test-retest reproducibility of ultrasound measurements. The Chi-Square test will be used to compare the level of physical activity (pre-training) between the groups. The results of the intervention will be expressed using descriptive statistics (mean, standard deviation, and standard error). The normality and sphericity of the data will be tested using the Shapiro-Wilk and Mauchly tests, respectively. A generalized estimating equation, followed by Bonferroni post-hoc, will be used to compare the effects of groups (G55 and G70) and times (pre-training, Post-6, and Post-12). A one-way ANOVA, followed by a Bonferroni post-hoc, will be used to compare the control group participants' limbs with the healthy and injured limbs from both intervention groups (G55 and G70) in the Pre and Post-12 times. The effect size will be estimated for each outcome. All statistical analyzes will be performed using SPSS software.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Men aged 18 to 64 who have ruptured their Achilles tendon unilaterally no more than 5 years ago;
  • •Who are not performing systematic and regular calf strength training.

Exclusion Criteria

  • •Non-surgical treatment for Achilles tendon rupture;
  • •History of postsurgical complications (infection or re-rupture);
  • •Presence of any type of ankle injury in the last six month;
  • •Participation in a strength training program for plantar flexors in the last six months prior to participation in the study;
  • •Having heart failure; autoimmune diseases; and/or diabetes;
  • •Systematic use of antibiotics or steroids within the last 12 months;
  • •Presence of any other clinical contraindication for performing maximum strength tests.

Arms & Interventions

Strength training (low intensity)

Experimental

Twelve weeks of strength training program for the calf muscles, with low load intensity

Intervention: Exercise (Other)

Strength training (moderate intensity)

Experimental

Twelve weeks of strength training program for the calf muscles, with moderate load intensity

Intervention: Exercise (Other)

Healthy subjects

No Intervention

A control condition composed of healthy individuals (i.e., without any injury), who will not receive any training, will be used as a comparison at the beginning and end of the intervention.

Outcomes

Primary Outcomes

Changes in foot and ankle joint function

Time Frame: From baseline measurements up to 13 weeks after (i.e., one week after the end of the training program)

The foot and ankle joint function will be assessed through Foot and Ankle Outcome Score, which evaluate five different domains: pain, other symptoms, activities of daily living, sports and recreational activities, and quality of life related to the ankle and foot.

Changes in ankle functional performance

Time Frame: From baseline measurements up to 13 weeks after (i.e., one week after the end of the training program)

The ankle functional performance will be assessed using the heel raise test. With this test, the maximum height of the heel lift will be assessed, corresponding to the measurement of functionality of the ankle plantar flexors.

Changes in Achilles tendon function and symptom

Time Frame: From baseline measurements up to 13 weeks after (i.e., one week after the end of the training program)

Achilles tendon post-rupture function and symptoms will be assessed through Achilles Tendon Rupture Score (ATRS).

Changes in plantar flexors' muscle strength

Time Frame: From baseline measurements up to 13 weeks after (i.e., one week after the end of the training program)

The plantar flexors' muscle strength will be assessed by the peak torque in different ankle joints (i.e., -10º, 0º, and 20º of plantar flexion - 0º neutral position).

Changes in Achilles tendon stiffness

Time Frame: From baseline measurements up to 13 weeks after (i.e., one week after the end of the training program)

Tendon stiffness will be obtained by calculating the slope in the last 10% of the linear region of the force-deformation curve.

Secondary Outcomes

  • Changes in Achilles tendon Young's Modulus(From baseline measurements up to 13 weeks after (i.e., one week after the end of the training program))
  • Changes in Achilles tendon morphological properties(From baseline measurements up to 13 weeks after (i.e., one week after the end of the training program))
  • Changes in plantar flexors' muscle arquitecture(From baseline measurements up to 13 weeks after (i.e., one week after the end of the training program))
  • Changes in plantar flexors' muscle activation(From baseline measurements up to 13 weeks after (i.e., one week after the end of the training program))
  • Changes in neuromuscular recruitment capacity(From baseline measurements up to 13 weeks after (i.e., one week after the end of the training program))

Investigators

Sponsor
Federal University of Rio Grande do Sul
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeam Marcel Geremia

Principal Investigator

Federal University of Rio Grande do Sul

Study Sites (1)

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