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

Sponsor

University Hospital, Ghent (Other)

Overall Status

Recruiting

CT.gov ID

NCT06057779

Collaborator

(none)

Enrollment

Location

Arms

24.2

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Achilles Tendinopathy	Other: Slow and heavy exercise therapy Other: Slow and light exercise therapy Other: Fast and heavy exercise therapy	N/A

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.

Protocl 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, 25 mm proximal to the calcenal posterosuperior border, will be assessed. These properties include tendon thickness (anteroposterior diameter (mm) and cross-sectional arae (mm2)), tendon echogenicity (average grey value from 0 (black) to 255 (white) A.U.) and tendon stiffness by shear wave elastography (kPa).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Repeated measure designRepeated measure design

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 25, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Achilles tendon thickness [Baseline and immediatly following each protocol]
Tendon anteroposterior diameter will be assessed 25 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 [Baseline and immediatly following each protocol]
Tendon cross-sectional area of the Achilles tendon will be assessed 25 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 echogenicity [Baseline and immediatly following each protocol]
Echogenicity of the Achilles tendon will be assessed 25 mm proximal to the posterosuperior calcaneal border using ultrasound imaging and ImageJ. 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 [Baseline and immediatly following each protocol]
Echogenicity of the Achilles tendon will be assessed 25 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vakgroep Revalidatiewetenschappen UZ Gent, 1B3	Gent	Oost-Vlaanderen	Belgium	9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator: Luc Vanden Bossche, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT06057779

Other Study ID Numbers:

ONZ-2023-0238

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Ghent

Achilles tendon

Additional relevant MeSH terms:

Tendinopathy

Study Results

No Results Posted as of Sep 28, 2023