Clinical trial NCT06009536: Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?
Official title: Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Achilles Tendinopathy
Keywords: Achilles Tendinopathy
Ultrasonography
Resistance Training
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in Peak Spatial Frequency Radius at the site of Pathology
timeFrame: Change of initial values at 26 weeks follow up after beginning of the therapy.
measure: Change in Tendon Diameter at the Place of Maximum Tendon Width
timeFrame: Change of initial values at 26 weeks follow up after beginning of the therapy.
Secondary outcomes:
measure: Change in VISA-A Questionnaire Score
timeFrame: Change of initial values at 39 weeks follow up after beginning of the therapy.
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: University Hospital Motol and 2nd Faculty of Medicine, Charles University
Study officials:
affiliation: University Hospital Motol and 2nd Faculty of Medicine, Charles University
name: Stanislav Machac, PhD
role: STUDY_CHAIR
References: