The Effect of Loading Speed and Intensity During Exercise on the Immediate Structural Changes in the Achilles Tendon

June 3, 2024 updated by: University Hospital, Ghent

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Vakgroep Revalidatiewetenschappen UZ Gent, 1B3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Slow and heavy exercise therapy
Participants perform eccentric heel drop exercises into maximal dorsiflexion at slow speed.
Other: Slow and heavy exercise therapy
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.
Other: Slow and light exercise therapy
Participants perform eccentric heel drop exercises into neutral ankle position at slow speed.
Other: Slow and light exercise therapy
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.
Other: Fast and heavy exercise therapy
Participants perform eccentric heel drop exercises into maximal dorsiflexion at fast speed.
Other: Fast and heavy exercise therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Baseline and immediately following each protocol
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luc Vanden Bossche, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ONZ-2023-0238

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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