Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?

NCT ID: NCT06009536

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-05-01

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.

Conditions

Achilles Tendinopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Resistance training protocol

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.

Group Type: EXPERIMENTAL

Achilles Tendon Loading Exercise Protocol According to Silbernagel

Intervention Type: 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.

Participants with healthy tendons

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Achilles Tendon Loading Exercise Protocol According to Silbernagel

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Motol

OTHER

Sponsor Role: lead

Responsible Party

Stanislav Machač, Ph.D

Academic woorker

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stanislav Machac, PhD

Role: STUDY_CHAIR

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

Locations

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

Prague, , Czechia

Countries

Czechia

Other Identifiers

EK-402 /22b

Identifier Type: -

Identifier Source: org_study_id