Back to resultsDoes Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?
Primary Purpose
Achilles Tendinopathy
Status
Active
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Achilles Tendon Loading Exercise Protocol According to Silbernagel
Sponsored by
About this trial
This is an interventional basic science trial for Achilles Tendinopathy focused on measuring Achilles Tendinopathy, Ultrasonography, Resistance Training
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.
Sites / Locations
- University Hospital Motol and 2nd Faculty of Medicine, Charles University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Resistance training protocol
Participants with healthy tendons
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT06009536
First Posted
August 19, 2023
Last Updated
August 19, 2023
Sponsor
University Hospital, Motol
1. Study Identification
Unique Protocol Identification Number
NCT06009536
Brief Title
Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?
Official Title
Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Motol
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy
Keywords
Achilles Tendinopathy, Ultrasonography, Resistance Training
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resistance training protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Participants with healthy tendons
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Achilles Tendon Loading Exercise Protocol According to Silbernagel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Peak Spatial Frequency Radius at the site of Pathology
Description
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.
Time Frame
Change of initial values at 26 weeks follow up after beginning of the therapy.
Title
Change in Tendon Diameter at the Place of Maximum Tendon Width
Description
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.
Time Frame
Change of initial values at 26 weeks follow up after beginning of the therapy.
Secondary Outcome Measure Information:
Title
Change in VISA-A Questionnaire Score
Description
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.
Time Frame
Change of initial values at 39 weeks follow up after beginning of the therapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislav Machac, PhD
Organizational Affiliation
University Hospital Motol and 2nd Faculty of Medicine, Charles University
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Motol and 2nd Faculty of Medicine, Charles University
City
Prague
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?
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