Achilles Tendon RuptureTENDON-BFRNCT07131787
Optimizing Rehabilitation After Achilles Tendon Rupture Repair: The Role of Blood Flow Restriction Training in Tendon and Muscle Recovery
A study testing Blood flow restriction training (smart-cuff pro device) and Standardised strength training in people with Achilles Tendon Rupture and Blood Flow Restriction Therapy, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendon Rupture, Blood Flow Restriction Therapy
- What is being tested?
- Blood flow restriction training (smart-cuff pro device) and Standardised strength training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesBelgium
- Study dates
- 20 Aug 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with total midrupture Achilles tendon rupture
- surgical treatment
- > 18 years old
- able to understand and speak Dutch
Who cannot join
- Bilateral Achilles tendon rupture
- Previous Achilles tendon rupture
- Previous treatment with fluoroquinolones or cortisone
- other condition in either leg that would limit the ability to perform the exercises or evaluations
- Diabetes or rheumatic diseases
- History of deep venous thrombosis
- severe cardiovascular disease
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Not yet recruiting
Ghent University
Ghent, East-Flanders, 9000
Sarah VanDen Berghe, MSc, +32471178728, sarah.vandenberghe@ugent.be
- Recruiting
Ghent University Hospital
Ghent, 9000
Arne Burssens, Prof. Dr., +32 9 332 22 51, arne.burssens@ugent.be
About this study
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:
Read more
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:
- Undergo standard surgical repair of the Achilles tendon
- Be randomly assigned to a 24-week exercise therapy program-either with or without blood flow restriction (BFR)-starting four weeks post-surgery
- 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
- Being tested
- Blood flow restriction training (smart-cuff pro device), Standardised strength training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction training (smart-cuff pro device)Device
Also called Kaatsu, Partial vascular occlusion
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)
Standardised strength trainingOther
This group will undergo standard, traditional strength training consisting of calf, thigh, glute and core exercises.
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | Active comparator | control group: patients in this group will undergo the same standard strength training program as the BFR-group, but without a tourniquet. Receives: Other: Standardised strength training |
| Blood flow restriction group | Experimental | patients in this group will undergo a standard strength training program combined with an occlusion cuff. The cuff will be used during exercises targeting quadriceps and calf muscles. Receives: Device: Blood flow restriction training (smart-cuff pro device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achilles tendon rupture score (ATRS)
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.
Measured: 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
Secondary outcomes (18)
US: tendon cross-sectional area
measured by ultrasound
Measured: week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52
US: tendon length
Description: measured by ultrasound
Measured: week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52
SWE: tendon stiffness
Tendon stiffness measured by Shear Wave Elastography, range 0-800kPa with higher kPa representing higher stiffness
Measured: week 4, week 8, week 12, week 18, week 24 Follow-up at week 52
Power doppler
Doppler signal for vascularisation
Measured: week 4, week 8, week 12, week 18, week 24 Follow-up at week 52
Heel rise endurance test
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.
Measured: week 18, week 24 Follow-up at week 52
Possibility to perform one heel rise
Physical test where the patient is assessed based on the ability to perform one heel rise. Yes/no
Measured: week 12
Plantarflexion strength
Isokinetic strength test measured by dynamometry (Biodex)
Measured: week 18, week 24, Follow-up at week 52
Tampa scale of kinesophobia (TSK)
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.
Measured: week 4, week 24
EQ-5D-5L
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.
Measured: week 0, week 4, week 12, week 24 Follow-up at week 52
Tegner Activity Scale (TAS)
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.
Measured: From enrollment week 0 (pre-injury), week 18, week 24, Follow-up at week 52
MRI: muscle volume
Based on MRI images, muscle volume will be calculated of plantarflexor muscles.
Measured: week 4 and week 24 (pre- and post physical therapy)
MRI: fatty infiltration
Based on MRI images, fatty infiltration will be calculated
Measured: week 4 and week 24 (pre- and post physical therapy)
Fear of rerupture
Yes/no question to assess fear of rerupture of the patient
Measured: week 4, week 12, week 24 Follow-up at week 52
Unilateral drop jump test
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.
Measured: week 24, Follow-up at week 52
Unilateral counter movement jump
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.
Measured: week 24, Follow-up at week 52
International Physical Activity Questionnaire - Short form (IPAQ-SF)
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.
Measured: week 0, week 4, week 8, week 12, week 18, week 24 Follow-up week 52
Tendon biopt histology
Histologic evaluation of tendon biopt which is collected during surgery: cellularity, cell roundness (morphology), collagen arrangement and ground substance (proteogylcans).
Measured: week 0
Tendon biopt mRNA
mRNA sequencing on tendon biopt collected during surgery
Measured: week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start20 Aug 2025
- Primary completionMay 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arne Burssens, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131787
- Sponsor's protocol ID
- ONZ-2025-0152
- Acronym
- TENDON-BFR
- Status last verified
- Apr 2025
- First submitted
- 29 Jul 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Rehabilitation After Achilles Tendon Rupture Repair: The Role of Blood Flow Restriction Training in Tendon and Muscle Recovery
- ClinicalTrials.gov ID
- NCT07131787
- Acronym / sponsor ID
- TENDON-BFR / ONZ-2025-0152
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Undergo standard surgical repair of the Achilles tendon
- Be randomly assigned to a 24-week exercise therapy program-either with or without blood flow restriction (BFR)-starting four weeks post-surgery
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | Active comparator | Other: Standardised strength trainingcontrol group: patients in this group will undergo the same standard strength training program as the BFR-group, but without a tourniquet. |
| Blood flow restriction group | Experimental | Device: Blood flow restriction training (smart-cuff pro device)patients in this group will undergo a standard strength training program combined with an occlusion cuff. The cuff will be used during exercises targeting quadriceps and calf muscles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with total midrupture Achilles tendon rupture
- surgical treatment
- > 18 years old
- able to understand and speak Dutch
Key exclusion criteria (7 listed)
- Bilateral Achilles tendon rupture
- Previous Achilles tendon rupture
- Previous treatment with fluoroquinolones or cortisone
- other condition in either leg that would limit the ability to perform the exercises or evaluations
- Diabetes or rheumatic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restriction training (smart-cuff pro device)Also: Kaatsu, Partial vascular occlusionThis 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) | Device | Blood flow restriction group |
| Standardised strength trainingThis group will undergo standard, traditional strength training consisting of calf, thigh, glute and core exercises. | Other | Conventional therapy |
Primary outcome
Achilles tendon rupture score (ATRS)
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.
18 secondary outcomes
US: tendon cross-sectional area
Time frame: week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52
US: tendon length
Time frame: week 4 (pre), week 8, week 12, week 18 and week 24 (post), Follow-up at week 52
SWE: tendon stiffness
Time frame: week 4, week 8, week 12, week 18, week 24 Follow-up at week 52
Power doppler
Time frame: week 4, week 8, week 12, week 18, week 24 Follow-up at week 52
Heel rise endurance test
Time frame: week 18, week 24 Follow-up at week 52
Possibility to perform one heel rise
Time frame: week 12
Plantarflexion strength
Time frame: week 18, week 24, Follow-up at week 52
Tampa scale of kinesophobia (TSK)
Time frame: week 4, week 24
EQ-5D-5L
Time frame: week 0, week 4, week 12, week 24 Follow-up at week 52
Tegner Activity Scale (TAS)
Time frame: From enrollment week 0 (pre-injury), week 18, week 24, Follow-up at week 52
MRI: muscle volume
Time frame: week 4 and week 24 (pre- and post physical therapy)
MRI: fatty infiltration
Time frame: week 4 and week 24 (pre- and post physical therapy)
Fear of rerupture
Time frame: week 4, week 12, week 24 Follow-up at week 52
Unilateral drop jump test
Time frame: week 24, Follow-up at week 52
Unilateral counter movement jump
Time frame: week 24, Follow-up at week 52
International Physical Activity Questionnaire - Short form (IPAQ-SF)
Time frame: week 0, week 4, week 8, week 12, week 18, week 24 Follow-up week 52
Tendon biopt histology
Time frame: week 0
Tendon biopt mRNA
Time frame: week 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Achilles Tendon Rupture
Not yet recruiting
Early Functional Outcomes After Open Versus Percutaneous Repair of Acute Achilles Tendon Ruptures
Patients With an Acute Achilles Tendon Rupture, Time From Achilles Tendon Rupture to Surgery of Less Than 2 Weeks
Recruiting
Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
Achilles Tendon Rupture
Enrolling by invitationObservational study
Achilles Non-SNIS REGENETEN
Complete Mid-portion Achilles Rupture
RecruitingObservational study
Achilles Tendon Rupture Patient Outcomes at 12 Months
Achilles Tendon Rupture
Recruiting
Effect of BFR Rehab After Achilles Tendon Rupture
Achilles Tendon Rupture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arne Burssens, Professor principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction training (smart-cuff pro device) and Standardised strength training in people with Achilles Tendon Rupture and Blood Flow Restriction Therapy, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah VanDen Berghe (+32471178728, sarah.vandenberghe@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achilles tendon rupture score (ATRS) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.