Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?

Conditions
-----------------
Achilles Tendinopathy

Intervention / Treatment
-----------------
* Other: Achilles Tendon Loading Exercise Protocol According to Silbernagel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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.). Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance training protocol<br>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. | Other: Achilles Tendon Loading Exercise Protocol According to Silbernagel<br>* 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.<br>|
| No Intervention: Participants with healthy tendons<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Change of initial values at 26 weeks follow up after beginning of the therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change of initial values at 39 weeks follow up after beginning of the therapy. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Achilles Tendinopathy, Ultrasonography, Resistance Training