NCT Number: NCT07131787
The goal of this clinical trial is to investigate whether rehabilitation with blood flow restriction (BFR) offers added value compared to conventional rehabilitation in patients undergoing surgical repair for Achilles tendon rupture. The study will include adult patients of all sexes who have undergone surgical treatment at two selected hospitals.
The main questions it aims to answer are:
Does BFR-enhanced rehabilitation improve functional recovery compared to conventional rehabilitation? What are the effects of BFR on muscle strength and tendon recovery?
Researchers will compare blood flow restriction (BFR) therapy with conventional rehabilitation to determine whether BFR leads to improved clinical, muscular, and tendon-related outcomes.
Participants will:
1. Undergo standard surgical repair of the Achilles tendon 2. Be randomly assigned to a 24-week exercise therapy program-either with or without blood flow restriction (BFR)-starting four weeks post-surgery 3. Take part in follow-up assessments at weeks 4, 8, 12, 18, 24, and 52, which will include:
* Questionnaires on pain, quality of life, fear of movement, and return to sport * Medical imaging techniques such as ultrasound, MRI, shear wave elastography, and power Doppler * Muscle strength testing * Blood sample collection, along with a tendon tissue sample taken during surgery
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Ghent University, Ghent, East-Flanders, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This group will undergo low load strength training consisting of calf, thigh, glute and core exercises. A Blood flow restriction cuff will be added during selected exercises in rehabilitation program (targeting quadriceps and calf muscles)
Other names: Kaatsu, Partial vascular occlusion
This group will undergo standard, traditional strength training consisting of calf, thigh, glute and core exercises.
Time frame: From enrollment week 0 (pre-injury score), week 12, week 18 and week 24 (the end of treatment at 6 months post-operative). Follow-up screening at week 52
The ATRS is a validated 10-item (score 0-10) self-report questionnaire designed specifically for Achilles tendon rupture patients. total scores range from 0-100, with a higher score representing worst symptoms and physical activity.
Time frame: week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52
measured by ultrasound
Time frame: week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52
Description: measured by ultrasound
Time frame: week 4, week 8, week 12, week 18, week 24 Follow-up at week 52
Tendon stiffness measured by Shear Wave Elastography, range 0-800kPa with higher kPa representing higher stiffness
Time frame: week 4, week 8, week 12, week 18, week 24 Follow-up at week 52
Doppler signal for vascularisation
Time frame: week 18, week 24 Follow-up at week 52
The Heel Rise Endurance Test (HRET) is a functional assessment used to evaluate calf muscle endurance and strength following an Achilles tendon rupture. It involves repeatedly raising up onto the toes (heel raises) on one leg until exhaustion, with the number of repetitions recorded as a measure of performance. This test helps quantify the recovery of plantar flexion strength and endurance after injury. Combined with a linear encoder, also heel rise height and work is calculated.
Time frame: week 12
Physical test where the patient is assessed based on the ability to perform one heel rise. Yes/no
Time frame: week 18, week 24, Follow-up at week 52
Isokinetic strength test measured by dynamometry (Biodex)
Time frame: week 4, week 24
The Tampa Scale for Kinesiophobia (TSK) is a 17-item self-report questionnaire used to assess fear of movement or re-injury (kinesiophobia) in individuals, particularly those with musculoskeletal pain. It evaluates a patient's beliefs about the potential dangers of physical activity and how those beliefs affect their willingness to move. The TSK has a 4-point Likert scale (strongly disagree to strongly agree) for each item. The total score can vary from 17 tot 68, with a higher score representing higher kinesiophobia.
Time frame: week 0, week 4, week 12, week 24 Follow-up at week 52
The EQ-5D-5L is a standardized instrument used to measure health-related quality of life. It consists of two parts: a descriptive system and a visual analogue scale (EQ-VAS). The descriptive system includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, ranging from "no problems" to "extreme problems" or "unable to". The EQ-VAS asks the respondent to rate their overall health on a scale of 0 to 100.
Time frame: From enrollment week 0 (pre-injury), week 18, week 24, Follow-up at week 52
The TAS is a one-item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 represents maximum disability while a level of 10 represents elite sports athletes. Patients are asked to choose the highest level of activity they partake in at that moment.
Time frame: week 4 and week 24 (pre- and post physical therapy)
Based on MRI images, muscle volume will be calculated of plantarflexor muscles.
Time frame: week 4 and week 24 (pre- and post physical therapy)
Based on MRI images, fatty infiltration will be calculated
Time frame: week 4, week 12, week 24 Follow-up at week 52
Yes/no question to assess fear of rerupture of the patient
Time frame: week 24, Follow-up at week 52
The drop jump test is a plyometric exercise used to assess an athlete's reactive strength, specifically their ability to quickly transition from an eccentric (lengthening) muscle contraction during landing to a concentric (shortening) contraction during jumping, also including relevance of elastic energy storage in the tendon. It involves dropping from a predetermined height and immediately jumping as high as possible upon landing. The test measures the athlete's reactive strength index (RSI), which is calculated by dividing jump height by ground contact time.
Time frame: week 24, Follow-up at week 52
A unilateral countermovement jump (CMJ) is a jump test where an individual stands on one leg and performs a countermovement before jumping as high as possible, primarily assessing single-leg explosive power and interlimb asymmetries.
Time frame: week 0, week 4, week 8, week 12, week 18, week 24 Follow-up week 52
IPAQ measures the time per week spent on walking, moderate or vigorous physical activity during different aspects of life (work, leisure, household tasks, etc.). The time active will be converted to Metabolic Equivalent of a task (MET)-minutes per week. The higher the MET value, the higher the energy expenditure/physical activity.
Time frame: week 0
Histologic evaluation of tendon biopt which is collected during surgery: cellularity, cell roundness (morphology), collagen arrangement and ground substance (proteogylcans).
Time frame: week 0
mRNA sequencing on tendon biopt collected during surgery
Contact information is provided by the study sponsor or research team.
University Hospital, Ghent
Other
Acronym: TENDON-BFR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07498166
Achilles Tendon Repairs/Reconstructions, Achilles Tendon Rupture
Boston, Massachusetts, United States
View Trial DetailsNCT07130357
Achilles Tendon Rupture
Shatin, New Territories, Hong Kong
View Trial DetailsNCT07453485
Achilles Tendinopathy (AT), Achilles Tendon Rupture
Brasília, Federal District, Brazil
View Trial DetailsNCT06912269
Achilles Tendon Rupture, Neuromuscular Adaptations
Porto Alegre, Rio Grande do Sul, Brazil
View Trial Details