NCT06057779

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

August 23, 2023

Last Update Submit

June 3, 2024

Conditions

Keywords

Achilles tendon

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline and immediately following each protocol

Study Arms (3)

Slow and heavy exercise therapy

OTHER

Participants perform eccentric heel drop exercises into maximal dorsiflexion at slow speed.

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.

Other: Slow and light exercise therapy

Fast and heavy exercise therapy

OTHER

Participants perform eccentric heel drop exercises into maximal dorsiflexion at fast speed.

Other: Fast and heavy exercise therapy

Interventions

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 heavy 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.

Slow and light 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.

Fast and heavy exercise therapy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 55 years
  • Participate in recreational or competitive sport (at least 1x/week)

You may not qualify if:

  • History of Achilles tendinopathy
  • Presence of rheumatological disease
  • Not able to complete an exercise programme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vakgroep Revalidatiewetenschappen UZ Gent, 1B3

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (1)

  • 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.

Study Officials

  • Luc Vanden Bossche

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor was blinded to the specific intervention (protocol type); due to the nature of the interventions, participants were aware of the exercise intervention they were performing each week. However, participants will not be informed of the hypothesis of the study nor will this be disclosed at any time in written materials or verbal interactions.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Repeated measure design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

September 28, 2023

Study Start

September 25, 2023

Primary Completion

January 10, 2024

Study Completion

January 10, 2024

Last Updated

June 5, 2024

Record last verified: 2024-06

Locations