Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?

NCT06009536 | Unknown

• 1 other identifier: EK-402 /22b
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendinopathy

Keywords

Achilles Tendinopathy; Ultrasonography; Resistance Training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in VISA-A Questionnaire Score

  Change of initial values at 39 weeks follow up after beginning of the therapy.

Study Arms (2)

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.

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.

Interventions

Achilles Tendon Loading Exercise Protocol According to Silbernagel OTHER

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.

Resistance training protocol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

University Hospital Motol and 2nd Faculty of Medicine, Charles University

Prague, Czechia

Location

Study Officials

• Stanislav Machac, PhD

  University Hospital Motol and 2nd Faculty of Medicine, Charles University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic woorker

Study Record Dates

• First Submitted: August 19, 2023
• First Posted: August 24, 2023
• Study Start: January 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)