- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06057779
The Effect of Loading Speed and Intensity During Exercise on the Immediate Structural Changes in the Achilles Tendon
The Effect of Loading Speed and Intensity During Exercise on the Immediate Changes in Achilles Tendon Thickness and Stiffness: a Randomised Crossover Trial
Aim: To assess the influence of loading speed and intensity during eccentric heel drop exercise on the immediate changes in Achilles tendon thickness and stiffness in healthy controls.
Intervention: Three eccentric heel drop exercise protocols, different in loading speed and/or loading intensity will be compared. Each participant will perform a single protocol per session in a random sequence at 1-week intervals.
Participants: a total of 30 healthy athletes will be included.
Outcome measure: tendon thickness and stiffness will be measured at baseline and immediately following intervention with ultrasound imaging (B-mode) and shear wave elastography, respectively.
Discussion: the study will determine whether an eccentric exercise intervention involving a low loading speed and high intensity could maximize the immediate reduction in thickness and associated increase in stiffness of the Achilles tendon compared with interventions involving a higher loading speed and lower intensity.
Study Overview
Status
Conditions
Detailed Description
Mechanical loading of the Achilles tendon during isolated eccentric contractions induces immediate changes in its structural properties. However, it is not known whether the loading speed and intensity has any impact on these changes. Therefore, this study aims to investigate the influence of loading speed and intensity during eccentric heel drop exercises on the immediate changes in Achilles tendon thickness and stiffness in healthy controls.
Each participant will perform eccentric heel-drops on their dominant leg with and a fully extended knee, and with additional 20% body weight (added via a weighted backpack). Participants will stand with the forefoot of the tested limb on the edge of a step, with the ankle maximally plantar flexed and with body weight centred on this limb. Eccentric loading occurs when the participant lowers the heel to a predetermined angle and speed (depending on the type of intensity and speed cfr infra). In order to return to baseline, the body mass will therefore be shifted to the non-dominant leg to raise the body. Visual feedback (monitor) will be in front of the subjects and the exercise parameters (velocity and ankle angle) will be guided by software guidelines (Ultium Motion).
Three protocols will be compared that differ in execution speed (namely a fast protocol; 1 Hz: 1 second per repetition versus a slow protocol; 0.33 Hz: 3 seconds per repetition) and loading intensity (namely heavy; exercise into maximal dorsiflexion versus light; exercise into neutral ankle position).
Protocol 1 (=Heavy x Slow): subjects perform eccentric heel drops from a maximal plantarflexion position to a maximal dorsiflexion position at a speed of 0.33 Hz, i.e. 3 seconds per movement cycle.
Protocol 2 (=Heavy x Fast): subjects perform eccentric heel drops from a maximal plantarflexion position to a maximal dorsiflexion position at a speed of 3 Hz, i.e. 1 seconds per movement cycle.
Protocol 3 (=Light x Slow): subjects perform eccentric heel drops from a maximal plantarflexion position to a neutral ankle position at a speed of 0.33 Hz, i.e. 3 seconds per movement cycle.
Participants will perform one exercise protocol per session, in a random order, and the interval between each session is one week. Six sets will be performed per session, with one minute of rest between each set. In order to ensure that the Achilles tendon's time under tension is the same for each protocol (180 seconds), 30 repetitions will performed per set for the fast protocol and 10 repetitions for the slow protocol. The approximate duration of each intervention will be 15 minutes. Before and immediately after each protocol, the structural properties of the Achilles tendon, 20 mm proximal to the calcaneal posterosuperior border, will be assessed. These properties include tendon thickness (anteroposterior diameter (mm), cross-sectional arae (mm2)), and tendon stiffness by shear wave elastography (m/s).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lauren Pringels
- Phone Number: +3249531292
- Email: lauren.pringels@ugent.be
Study Locations
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Oost-Vlaanderen
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Gent, Oost-Vlaanderen, Belgium, 9000
- Vakgroep Revalidatiewetenschappen UZ Gent, 1B3
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 55 years
- Participate in recreational or competitive sport (at least 1x/week)
Exclusion Criteria:
- History of Achilles tendinopathy
- Presence of rheumatological disease
- Not able to complete an exercise programme
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Slow and heavy exercise therapy
Participants perform eccentric heel drop exercises into maximal dorsiflexion at slow speed.
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6 sets of 10 single leg isolated eccentric heel drops into maximal dorsiflexion at an exercise speed of 0.33 Hz, with 1-min rest period between each set.
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Other: Slow and light exercise therapy
Participants perform eccentric heel drop exercises into neutral ankle position at slow speed.
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6 sets of 10 single leg isolated eccentric heel drops into neutral ankle position at an exercise speed of 0.33 Hz, with 1-min rest period between each set.
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Other: Fast and heavy exercise therapy
Participants perform eccentric heel drop exercises into maximal dorsiflexion at fast speed.
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6 sets of 30 single leg isolated eccentric heel drops into maximal dorsiflexion at an exercise speed of 1 Hz, with 1-min rest period between each set.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Achilles tendon thickness
Time Frame: Baseline and immediately following each protocol
|
Tendon anteroposterior diameter will be assessed 20 mm proximal to the posterosuperior calcaneal border using ultrasound imaging.
The Achilles tendon is scanned at rest with the subject in the prone position and the foot passively maintained in a neutral position.
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Baseline and immediately following each protocol
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Achilles tendon cross-sectional area
Time Frame: Baseline and immediately following each protocol
|
Tendon cross-sectional area of the Achilles tendon will be assessed 20 mm proximal to the posterosuperior calcaneal border using ultrasound imaging.
The Achilles tendon is scanned at rest with the subject in the prone position and the foot passively maintained in a neutral position.
|
Baseline and immediately following each protocol
|
Achilles tendon stiffness
Time Frame: Baseline and immediately following each protocol
|
Echogenicity of the Achilles tendon will be assessed 20 mm proximal to the posterosuperior calcaneal border using shear wave elastography.
The Achilles tendon is scanned at rest with the subject in the prone position and the foot passively maintained in a 30° plantar flexion.
|
Baseline and immediately following each protocol
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luc Vanden Bossche, University Hospital, Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONZ-2023-0238
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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