The Effect of Loading Speed and Intensity During Exercise on the Immediate Structural Changes in the Achilles Tendon
Primary Purpose
Achilles Tendinopathy
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Slow and heavy exercise therapy
Slow and light exercise therapy
Fast and heavy exercise therapy
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendinopathy focused on measuring Achilles tendon
Eligibility Criteria
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
Sites / Locations
- Vakgroep Revalidatiewetenschappen UZ Gent, 1B3Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Slow and heavy exercise therapy
Slow and light exercise therapy
Fast and heavy exercise therapy
Arm Description
Participants perform eccentric heel drop exercises into maximal dorsiflexion at slow speed.
Participants perform eccentric heel drop exercises into neutral ankle position at slow speed.
Participants perform eccentric heel drop exercises into maximal dorsiflexion at fast speed.
Outcomes
Primary Outcome Measures
Achilles tendon thickness
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
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06057779
First Posted
August 23, 2023
Last Updated
October 20, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT06057779
Brief Title
The Effect of Loading Speed and Intensity During Exercise on the Immediate Structural Changes in the Achilles Tendon
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy
Keywords
Achilles tendon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Repeated measure design
Masking
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.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Slow and heavy exercise therapy
Arm Type
Other
Arm Description
Participants perform eccentric heel drop exercises into maximal dorsiflexion at slow speed.
Arm Title
Slow and light exercise therapy
Arm Type
Other
Arm Description
Participants perform eccentric heel drop exercises into neutral ankle position at slow speed.
Arm Title
Fast and heavy exercise therapy
Arm Type
Other
Arm Description
Participants perform eccentric heel drop exercises into maximal dorsiflexion at fast speed.
Intervention Type
Other
Intervention Name(s)
Slow and heavy exercise therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Slow and light exercise therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fast and heavy exercise therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Achilles tendon thickness
Description
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.
Time Frame
Baseline and immediatly following each protocol
Title
Achilles tendon cross-sectional area
Description
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.
Time Frame
Baseline and immediatly following each protocol
Title
Achilles tendon echogenicity
Description
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.
Time Frame
Baseline and immediatly following each protocol
Title
Achilles tendon stiffness
Description
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.
Time Frame
Baseline and immediatly following each protocol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Pringels
Phone
+3249531292
Email
lauren.pringels@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Vanden Bossche
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vakgroep Revalidatiewetenschappen UZ Gent, 1B3
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Pringels, Dr.
Phone
0032 93321260
Email
lauren.pringels@ugent.be
First Name & Middle Initial & Last Name & Degree
Lauren Pringels, Dr.
12. IPD Sharing Statement
Learn more about this trial
The Effect of Loading Speed and Intensity During Exercise on the Immediate Structural Changes in the Achilles Tendon
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