Achilles TendinopathyNCT06057779
The Effect of Loading Speed and Intensity During Exercise on the Immediate Structural Changes in the Achilles Tendon
A study testing Slow and heavy exercise therapy, Slow and light exercise therapy and Fast and heavy exercise therapy in people with Achilles Tendinopathy, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Slow and heavy exercise therapy, Slow and light exercise therapy and Fast and heavy exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Sep 2023to 10 Jan 2024
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 55 years
- Participate in recreational or competitive sport (at least 1x/week)
Who cannot join
- History of Achilles tendinopathy
- Presence of rheumatological disease
- Not able to complete an exercise programme
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Vakgroep Revalidatiewetenschappen UZ Gent, 1B3
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: 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.
Read more
Participants: a total of 34 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.
Read the 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).
- Conditions
- Achilles Tendinopathy
- Being tested
- Slow and heavy exercise therapy, Slow and light exercise therapy, Fast and heavy exercise therapy
- Keywords
- Achilles tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow and heavy exercise therapyOther
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.
Slow and light exercise therapyOther
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.
Fast and heavy exercise therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Slow and heavy exercise therapy | Other | Participants perform eccentric heel drop exercises into maximal dorsiflexion at slow speed. Receives: Other: Slow and heavy exercise therapy |
| Slow and light exercise therapy | Other | Participants perform eccentric heel drop exercises into neutral ankle position at slow speed. Receives: Other: Slow and light exercise therapy |
| Fast and heavy exercise therapy | Other | Participants perform eccentric heel drop exercises into maximal dorsiflexion at fast speed. Receives: Other: Fast and heavy exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achilles tendon thickness
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.
Measured: Baseline and immediately following each protocol
Achilles tendon cross-sectional area
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.
Measured: Baseline and immediately following each protocol
Achilles tendon stiffness
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.
Measured: Baseline and immediately following each protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start25 Sep 2023
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies 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
- Crossover
- Model description
- Repeated measure design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc Vanden Bossche, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057779
- Sponsor's protocol ID
- ONZ-2023-0238
- Status last verified
- Jun 2024
- First submitted
- 23 Aug 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pringels L, Pieters D, VAN DEN Berghe S, Witvrouw E, Burssens A, Vanden Bossche L, Wezenbeek E. Loading Speed and Intensity in Eccentric Calf Training Impact Acute Changes in Achilles Tendon Thickness and Stiffness: A Randomized Crossover Trial. Med Sci Sports Exerc. 2025 May 1;57(5):895-903. doi: 10.1249/MSS.0000000000003638. Epub 2024 Dec 30.
PubMed 39787521
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Loading Speed and Intensity During Exercise on the Immediate Changes in Achilles Tendon Thickness and Stiffness: a Randomised Crossover Trial
- ClinicalTrials.gov ID
- NCT06057779
- Acronym / sponsor ID
- ONZ-2023-0238
- Conditions
- Achilles Tendinopathy
- Keywords
- Achilles tendon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 28 Sep 2023 (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.
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 34 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Repeated measure design
| Arm | Type | Receives |
|---|---|---|
| Slow and heavy exercise therapy | Other | Other: Slow and heavy exercise therapyParticipants perform eccentric heel drop exercises into maximal dorsiflexion at slow speed. |
| Slow and light exercise therapy | Other | Other: Slow and light exercise therapyParticipants perform eccentric heel drop exercises into neutral ankle position at slow speed. |
| Fast and heavy exercise therapy | Other | Other: Fast and heavy exercise therapyParticipants perform eccentric heel drop exercises into maximal dorsiflexion at fast speed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 to 55 years
- Participate in recreational or competitive sport (at least 1x/week)
Key exclusion criteria (3 listed)
- History of Achilles tendinopathy
- Presence of rheumatological disease
- Not able to complete an exercise programme
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 |
|---|---|---|
| Slow and heavy exercise therapy6 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. | Other | Slow and heavy exercise therapy |
| Slow and light exercise therapy6 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. | Other | Slow and light exercise therapy |
| Fast and heavy exercise therapy6 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. | Other | Fast and heavy exercise therapy |
Primary outcome
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.
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.
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.
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 5 Jun 2024.
- Derived from this study: PubMed 39787521Pringels L, Pieters D, VAN DEN Berghe S, Witvrouw E, Burssens A, Vanden Bossche L, Wezenbeek E. Loading Speed and Intensity in Eccentric Calf Training Impact Acute Changes in Achilles Tendon Thickness and Stiffness: A Randomized Crossover Trial. Med Sci Sports Exerc. 2025 May 1;57(5):895-903. doi: 10.1249/MSS.0000000000003638. Epub 2024 Dec 30.
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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.
Luc Vanden Bossche principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow and heavy exercise therapy, Slow and light exercise therapy and Fast and heavy exercise therapy in people with Achilles Tendinopathy, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 3 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 5 Jun 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 Belgium. 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?
Achilles tendon thickness (time frame: Baseline and immediately following each protocol). The study lists 3 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 NCT06057779, which also lists 1 linked publication.
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 5 Jun 2024; AzTrials last refreshed its copy on 30 Oct 2026.