Achilles TendinopathyNCT06009536
Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?
A study testing Achilles Tendon Loading Exercise Protocol According to Silbernagel in people with Achilles Tendinopathy, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
This work is designed as a prospective cohort study, in which the effects of a protocol of 12-week resistance training loading the Achilles tendon in patients with Achilles tendinopathy (AT) will be monitored. It is estimated that at least 20 patients will participate. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Achilles Tendon Loading Exercise Protocol According to Silbernagel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2023to 1 May 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- the patient shows symptoms of Achilles tendinopathy (pain, swelling and dysfunction in the area of Achilles tendon), which at least partially limit his quality of life during normal or sporting activities,
- the patient is in the age group of 18-60 years,
- the patient has difficulties in only one lower limb; the second, asymptomatic limb will be considered the reference,
- the patient is not aware of any mechanical damage to the tendon in symptomatic limb in the past (e.g. partial or complete rupture as a result of an injury),
- the patient has not undergone any treatment aimed at AS in the last 3 months (surgery, corticoid application, plasma therapy, shock waves, physiotherapy, etc.), objective US examination of AS shows structural changes (expansion, neovascularization, focal hypoechoic areas, etc.).
Who cannot join
- patient has been diagnosed with a rheumatic disease or a disease of the central nervous system
- patient is aware of mechanical damage to the Achilles tendon as a result of an injury in the past.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Motol and 2nd Faculty of Medicine, Charles University
Prague
About this study
This work is designed as a prospective cohort study, in which the effects of a protocol of 12-week resistance training loading the Achilles tendon in patients with Achilles tendinopathy (AT) will be monitored. It is estimated that at least 20 patients will participate. In addition, there will be a small control group of healthy participants which will not complete the same protocol, but will be monitored for natural changes in same objectives. Group of patients will be instructed to perform a training protocol.
Read the detailed description
The research within one participant will last a total of 26 weeks from the initial to the final examination and will include control measurements at 6 and 12 weeks from the beginning of therapy. Potential participants will be selected based on the recommendation of a specialist doctor and their suitability will be assessed according to the inclusion criteria. They will then be invited to an initial examination. This will include an objective examination by a physiotherapist, a subjective assessment by the patient and an ultrasonographic (USG) examination followed by a micromorphological analysis using special software. At the end of the initial examination, the participant will be informed about training protocol.
- Conditions
- Achilles Tendinopathy
- Being tested
- Achilles Tendon Loading Exercise Protocol According to Silbernagel
- Keywords
- Achilles Tendinopathy, Ultrasonography, Resistance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Achilles Tendon Loading Exercise Protocol According to SilbernagelOther
It is a 12-week Silbernagel ankle dorsiflexion resistance training protocol. It is a series of exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training protocol | Experimental | Participants in this group will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day. Receives: Other: Achilles Tendon Loading Exercise Protocol According to Silbernagel |
| Participants with healthy tendons | No intervention | Participants in this group are considered healthy based on subjective judgment followed by clinical and ultrasound examination of the Achilles tendon. In this group, no specific treatment will be performed, only Achilles tendon will be monitored through time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Spatial Frequency Radius at the site of Pathology
Measured by spatial frequency analysis software from ultrasound picture in mm-1. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the PSFR parameter.
Measured: Change of initial values at 26 weeks follow up after beginning of the therapy.
Change in Tendon Diameter at the Place of Maximum Tendon Width
Measured by tools in ultrasound machine in mm2. In linear view is selected maximal width place, then the tendon diameter is measured using device tools.
Measured: Change of initial values at 26 weeks follow up after beginning of the therapy.
Secondary outcomes (1)
Change in VISA-A Questionnaire Score
The VISA-A questionnaire is standardized questionnaire for patients with Achilles tendinopathy. The results are recorded in points (0-100 points). The higher score indicates patients better condition.
Measured: Change of initial values at 39 weeks follow up after beginning of the therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Jan 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Why it stopped: The study was withdrawn prior to enrollment. The objectives of this study were incorporated into a broader registered and completed study, making this record redundant and no longer necessary to maintain as a separate entry.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanislav Machač, Ph.D, University Hospital, Motol
- Investigators
- Stanislav Machac, PhD, Study chair, University Hospital Motol and 2nd Faculty of Medicine, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009536
- Sponsor's protocol ID
- EK-402 /22b
- Status last verified
- May 2026
- First submitted
- 19 Aug 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?
- ClinicalTrials.gov ID
- NCT06009536
- Acronym / sponsor ID
- EK-402 /22b
- Conditions
- Achilles Tendinopathy
- Keywords
- Achilles Tendinopathy, Ultrasonography, Resistance Training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn prior to enrollment. The objectives of this study were incorporated into a broader registered and completed study, making this record redundant and no longer necessary to maintain as a separate entry.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 24 Aug 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.
This work is designed as a prospective cohort study, in which the effects of a protocol of 12-week resistance training loading the Achilles tendon in patients with Achilles tendinopathy (AT) will be monitored. It is estimated that at least 20 patients will participate. In addition, there will be a small control group of healthy participants which will not complete the same protocol, but will be monitored for natural changes in same objectives. Group of patients will be instructed to perform a training protocol.
Detailed description
The research within one participant will last a total of 26 weeks from the initial to the final examination and will include control measurements at 6 and 12 weeks from the beginning of therapy. Potential participants will be selected based on the recommendation of a specialist doctor and their suitability will be assessed according to the inclusion criteria. They will then be invited to an initial examination. This will include an objective examination by a physiotherapist, a subjective assessment by the patient and an ultrasonographic (USG) examination followed by a micromorphological analysis using special software. At the end of the initial examination, the participant will be informed about training protocol.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training protocol | Experimental | Other: Achilles Tendon Loading Exercise Protocol According to SilbernagelParticipants in this group will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day. |
| Participants with healthy tendons | No intervention | –Participants in this group are considered healthy based on subjective judgment followed by clinical and ultrasound examination of the Achilles tendon. In this group, no specific treatment will be performed, only Achilles tendon will be monitored through time. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- the patient shows symptoms of Achilles tendinopathy (pain, swelling and dysfunction in the area of Achilles tendon), which at least partially limit his quality of life during normal or sporting activities,
- the patient is in the age group of 18-60 years,
- the patient has difficulties in only one lower limb; the second, asymptomatic limb will be considered the reference,
- the patient is not aware of any mechanical damage to the tendon in symptomatic limb in the past (e.g. partial or complete rupture as a result of an injury),
- the patient has not undergone any treatment aimed at AS in the last 3 months (surgery, corticoid application, plasma therapy, shock waves, physiotherapy, etc.), objective US examination of AS shows structural changes (expansion, neovascularization, focal hypoechoic areas, etc.).
Key exclusion criteria (2 listed)
- patient has been diagnosed with a rheumatic disease or a disease of the central nervous system
- patient is aware of mechanical damage to the Achilles tendon as a result of an injury in the past.
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 |
|---|---|---|
| Achilles Tendon Loading Exercise Protocol According to SilbernagelIt is a 12-week Silbernagel ankle dorsiflexion resistance training protocol. It is a series of exercises with a gradual progression of load according to defined criteria, which the patient practices every day. | Other | Resistance training protocol |
Primary outcome
Change in Peak Spatial Frequency Radius at the site of Pathology
Time frame: Change of initial values at 26 weeks follow up after beginning of the therapy.
Measured by spatial frequency analysis software from ultrasound picture in mm-1. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the PSFR parameter.
Change in Tendon Diameter at the Place of Maximum Tendon Width
Time frame: Change of initial values at 26 weeks follow up after beginning of the therapy.
Measured by tools in ultrasound machine in mm2. In linear view is selected maximal width place, then the tendon diameter is measured using device tools.
1 secondary outcome
Change in VISA-A Questionnaire Score
Time frame: Change of initial values at 39 weeks follow up after beginning of the therapy.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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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.
Stanislav Machac, PhD study chair
University Hospital Motol and 2nd Faculty of Medicine, Charles University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Achilles Tendon Loading Exercise Protocol According to Silbernagel in people with Achilles Tendinopathy, run by University Hospital, Motol at 1 site in Czechia.
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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 7 May 2026. 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 Czechia. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Peak Spatial Frequency Radius at the site of Pathology (time frame: Change of initial values at 26 weeks follow up after beginning of the therapy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.