Achilles Tendon RuptureBEANNCT06434272
Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
A study testing Early exercise with partial Blood Flow Restriction and Late exercise with partial Blood Flow Restriction in people with Achilles Tendon Rupture, run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to gain insights into the effects of Blood Flow Restriction Exercise (BFRE) in patients with an acute Achilles tendon Rupture. The main questions it aims to answer are: Is BFRE an effective adjunct to usual care when compared with only usual care? When is the optimal timing for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Early exercise with partial Blood Flow Restriction and Late exercise with partial Blood Flow Restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Jan 2025to 9 Jan 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
- aged 18 years or older
- have started initial treatment within 72 hours of Achilles tendon rupture
- understand written and spoken Danish
Who cannot join
- bilateral Achilles tendon rupture
- previous Achilles tendon rupture in either leg
- decreased lower extremity function, caused by conditions other than Achilles tendon rupture
- treated with fluoroquinolones within the last six months
- treated with corticosteroid injection(s) in the area near the Achilles tendon within the last six months.
- diabetes
Show all 9Show fewer
- previous diagnosed thrombosis
- Known atherosclerosis in the peripheral arteries of the lower limb
- other reasons for exclusion (cognitive deficits, inability to provide informed consent, requiring cast-treatment due to low compliance regarding gradual wedge removal, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, Denmark, 8200
Inger Mechlenburg, +45 21679062
About this study
Official title: The Effectiveness of Low-load Blood Flow Restriction Exercise in Patients With an Acute Achilles Tendon Rupture Treated Non-surgically
The goal of this clinical trial is to gain insights into the effects of Blood Flow Restriction Exercise (BFRE) in patients with an acute Achilles tendon Rupture. The main questions it aims to answer are:
Is BFRE an effective adjunct to usual care when compared with only usual care? When is the optimal timing for initiating BFRE: In the early treatment stage or at the later stage after hospital treatment? Participants will receive an intervention comprising 12 weeks of BFRE as an adjunct to usual care.
Read more
- Either in the initial 1-12 weeks after Achilles tendon rupture, or
- In the following 13-24 weeks after Achilles tendon rupture
Researchers will compare the two groups at 13 weeks (3 months) to compare BFRE to usual care, and at 25 weeks (6 months) to compare the two time points for initiating BFRE (early vs. late).
Read the detailed description
This is an assessor-blinded, randomized, controlled multicenter trial with patients allocated 1:1 to one of two parallel groups, with follow-up times at weeks 13 and 25 after allocation, and again at 12 months for patients who consent to additional follow-up.
Patients with an acute Achilles tendon rupture treated non-surgically are eligible for inclusion. All patients will receive a 12-week BFRE program, either in weeks 1-12 or 13-24 post allocation, as an add-on to usual care.
The BFRE program is performed three times weekly on the injured leg at 80% of the limb occlusion pressure required to restrict the arterial blood flow fully.
Outcome measures are assessed at baseline, week 13, and week 25 after allocation. The primary outcome at the week 13 follow-up is the Single-Leg Heel-Raise test which assesses the patient's ability to raise the heel of the injured leg a minimum of 2 cm. The primary outcome at the week 25 follow-up is the Achilles Total Tendon Rupture Score which assesses the patient's self-reported symptoms and physical activity.
During most of the initial trial phase (weeks 1-12), patients are treated at local hospitals, where recruitment, assessment, and randomization occur. Usual care at the hospitals consists of ankle immobilization with a gradual return to weight-bearing in the following weeks. In the latter half of the trial phase (weeks 13-24), patients have transitioned to municipal care, where usual care includes diverse exercises performed at home or training facilities.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Early exercise with partial Blood Flow Restriction, Late exercise with partial Blood Flow Restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early exercise with partial Blood Flow RestrictionOther
Also called BFR, BFRE, Blood Flow Restriction Exercise, BFR-T
The intervention comprises of 12 weeks of blood flow restriction exercise in weeks 1-12 after injury. Three weekly exercise sessions are performed. Six supervised sessions are provided during the 12 weeks.
Blood flow restriction of 80% of the limb occlusion pressure required to fully restrict the arterial blood flow is employed.
The intervention comprises three exercises: Seated leg extension, standing knee flexion, and seated heel-rise performed at home as an adjunct to usual care treatment.
Each exercise is performed in four sets of 30, 15, 15, +1 repetitions, with the fourth set (+1) being as many repetitions as possible.
Pause in between sets is 30 seconds. Pause in between exercises are 120 seconds.
In weeks 13-24, patients in this arm follow usual care treatment.
Late exercise with partial Blood Flow RestrictionOther
Also called BFR, BFRE, Blood Flow Restriction Exercise, BFR-T
The intervention comprises of 12 weeks of blood flow restriction exercise in weeks 13-24 after injury. Three weekly exercise sessions are performed. Six supervised sessions are provided during the 12 weeks.
Blood flow restriction of 80% of the limb occlusion pressure required to fully restrict the arterial blood flow is employed.
The intervention comprises three exercises: Leg press in machine, heel-rise in machine, knee flexion in machine performed at training facilities as an adjunct to usual care treatment. If facilities are unavailable, three home-based exercises will be provided.
Each exercise, regardless of study arm, is performed in four sets of 30, 15, 15, +1 repetitions, with the fourth set (+1) being as many repetitions as possible.
In weeks 1-12, patients in this arm follow usual care treatment.
| Study group | Role | What they receive |
|---|---|---|
| Early initiated Blood Flow Restriction Exercise | Experimental | Receives an intervention in adjunct to usual care in weeks 1-12, and continues with usual care in weeks 13-24. Receives: Other: Early exercise with partial Blood Flow Restriction |
| Late initiated Blood Flow Restriction Exercise | Experimental | Receives usual care in weeks 1-12, and receives an intervention in adjunct to usual care weeks 13-24. Receives: Other: Late exercise with partial Blood Flow Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-leg heel-rise test
Patient's ability to perform a Single-Leg Heel-rise, defined as the ability to raise the heel of the injured leg at least 2 cm while keeping the knee straight. The test is performed with patients standing on a flat surface with the ankle in a neutral position. Patients will be allowed to keep their balance by lightly touching a wall.
Measured: Primary outcome at 13 week test. Measured as a secondary outcome at 25 week test.
Achilles tendon Total Rupture Score (ATRS)
The ATRS is a validated patient-reported, injury-specific questionnaire regarding physical activity and symptoms. The ATRS consists of 10 items scored from 0 (major limitations) to 10 (no limitations), resulting in a score between 0 (worst) to 100 (best).
Measured: Primary outcome at 25 week test. It is also measured at baseline through recall of the pre-injury condition and at the 13 week test as a secondary outcome aswell as at 12 month follow-up.
Secondary outcomes (9)
30 seconds unilateral Sit to Stand test
The unilateral 30 second Sit to Stand test (unilateral 30STS) is a clinical test of lower extremity function. The unilateral 30STS tests how many correct repetitions of a sit to stand from a chair, a patient can complete in 30 seconds
Measured: The test will be performed on both legs at 13 week test and 25 test.
Calf circumference
The calf circumference is measured in centimeters (cm) on both legs using a tape measure 15 cm below the medial palpable joint line of the knee. Repeated measurements will be made until a consistent measurement is found.
Measured: The measurement will be performed on both legs at 13 week test and 25 test.
Thigh circumference
Thigh circumference is measured in centimeters (cm) on both legs using a tape measure 10 cm proximal to the apex patella. During measurement patients lay supine on an examination table with knees bent in a 90-degree angle.
Measured: The measurement will be performed on both legs at 13 week test and 25 test.
Achilles tendon elongation (ATRA)
The Achilles tendon length is indirectly measured by the Achilles tendon resting angle (ATRA), measuring the difference in passive dorsiflexion when lying prone with knees in a 90-degree angle.
Measured: The test will be performed on both legs at 13 week test and 25 test.
Single-leg heel-rise height
Patient's maximum heel-rise height measured in cm. The test is performed with patients standing on a flat surface with the ankle in a neutral position. Patients will be allowed to keep their balance by lightly touching a wall.
Measured: The test will be performed on both legs at 13 week test and 25 week test.
Single-leg heel-rise endurance test
The maximal number of correct single-leg heel-rise repetitions is measured. The test is performed with patients standing on a flat surface with the ankle in a neutral position. Patients will be allowed to keep their balance by lightly touching the wall.
Measured: The test will be performed on both legs at 25 week test.
Tampa Scale of Kinesiophobia 13-items (TSK-13)
The TSK-13 is a 13-item self-reported measure for fear of movement or reinjury, that has previously been used in patients with Achilles tendon rupture.
Measured: TSK-13 is measured at baseline, 13 week test, 25 test and at 12 month follow-up.
International Physical Activity Questionnaire-short form (IPAQ-SF)
The IPAQ-SF consists of 7 items on physical activity as time spent performing vigorous and moder-ate activities, the time spent walking, and time spent sitting during the past week. The IPAQ pro-vides an estimate of the total weekly physical activity measured in MET-minutes per week and total minutes spent sitting.
Measured: IPAQ-SF is measured at baseline through recall of pre-injury condition, 13 week test, 25 week test and at 12 month follow-up.
Adverse events
The number of adverse events and serious adverse events will be recorded and reported to a Data Safety Monitoring Board. Adverse events are defined as unexpected medical events related to the initial treatment. Serious adverse event are complications requiring further inpatient care, such as re-rupture of the Achilles tendon, non-union of the Achilles tendon, or deep venous thromboembolism and pulmonary embolism. Muscle soreness or mild pain following exercise is expected and not con-sidered an adverse event.
Measured: Measured continously, and evaluated at 13 week test , 25 week test and at 12 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start28 Jan 2025
- Primary completion9 Jan 2028 (estimated)
- Study completion9 Jan 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 of AarhusThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital, Gødstrup Hospital, Regionshospitalet Horsens
- Responsible party
- Sponsor
- Investigators
- Andreas Bentzen, MHSc, Principal investigator, University of AarhusInger Mechlenburg, DMSc, Study director, University of AarhusPer H. Gundtoft, MD, PhD, Study director, Aarhus University HospitalStian L. Jørgensen, PT, PhD, Study director, Regionshospitalet Horsens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434272
- Sponsor's protocol ID
- BEAN (1-10-72-192-23)
- Acronym
- BEAN
- Status last verified
- Aug 2026
- First submitted
- 23 May 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised patient-level data will be made available if required by the scientific journal, in which the results of the trial are published. Additionally, researchers presenting a justified cause for receiving the data can obtain it after a data access agreement has been signed.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Low-load Blood Flow Restriction Exercise in Patients With an Acute Achilles Tendon Rupture Treated Non-surgically
- ClinicalTrials.gov ID
- NCT06434272
- Acronym / sponsor ID
- BEAN / BEAN (1-10-72-192-23)
- Conditions
- Achilles Tendon Rupture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital, Gødstrup Hospital, Regionshospitalet Horsens
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 9 Jan 2028 (estimated)
- Study completion
- 9 Jan 2028 (estimated)
- First posted
- 30 May 2024 (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 gain insights into the effects of Blood Flow Restriction Exercise (BFRE) in patients with an acute Achilles tendon Rupture. The main questions it aims to answer are:
Is BFRE an effective adjunct to usual care when compared with only usual care? When is the optimal timing for initiating BFRE: In the early treatment stage or at the later stage after hospital treatment? Participants will receive an intervention comprising 12 weeks of BFRE as an adjunct to usual care.
- Either in the initial 1-12 weeks after Achilles tendon rupture, or
- In the following 13-24 weeks after Achilles tendon rupture
Researchers will compare the two groups at 13 weeks (3 months) to compare BFRE to usual care, and at 25 weeks (6 months) to compare the two time points for initiating BFRE (early vs. late).
Detailed description
This is an assessor-blinded, randomized, controlled multicenter trial with patients allocated 1:1 to one of two parallel groups, with follow-up times at weeks 13 and 25 after allocation, and again at 12 months for patients who consent to additional follow-up.
Patients with an acute Achilles tendon rupture treated non-surgically are eligible for inclusion. All patients will receive a 12-week BFRE program, either in weeks 1-12 or 13-24 post allocation, as an add-on to usual care.
The BFRE program is performed three times weekly on the injured leg at 80% of the limb occlusion pressure required to restrict the arterial blood flow fully.
Outcome measures are assessed at baseline, week 13, and week 25 after allocation. The primary outcome at the week 13 follow-up is the Single-Leg Heel-Raise test which assesses the patient's ability to raise the heel of the injured leg a minimum of 2 cm. The primary outcome at the week 25 follow-up is the Achilles Total Tendon Rupture Score which assesses the patient's self-reported symptoms and physical activity.
During most of the initial trial phase (weeks 1-12), patients are treated at local hospitals, where recruitment, assessment, and randomization occur. Usual care at the hospitals consists of ankle immobilization with a gradual return to weight-bearing in the following weeks. In the latter half of the trial phase (weeks 13-24), patients have transitioned to municipal care, where usual care includes diverse exercises performed at home or training facilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early initiated Blood Flow Restriction Exercise | Experimental | Other: Early exercise with partial Blood Flow RestrictionReceives an intervention in adjunct to usual care in weeks 1-12, and continues with usual care in weeks 13-24. |
| Late initiated Blood Flow Restriction Exercise | Experimental | Other: Late exercise with partial Blood Flow RestrictionReceives usual care in weeks 1-12, and receives an intervention in adjunct to usual care weeks 13-24. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 years or older
- have started initial treatment within 72 hours of Achilles tendon rupture
- understand written and spoken Danish
Key exclusion criteria (9 listed)
- bilateral Achilles tendon rupture
- previous Achilles tendon rupture in either leg
- decreased lower extremity function, caused by conditions other than Achilles tendon rupture
- treated with fluoroquinolones within the last six months
- treated with corticosteroid injection(s) in the area near the Achilles tendon within the last six months.
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 |
|---|---|---|
| Early exercise with partial Blood Flow RestrictionAlso: BFR, BFRE, Blood Flow Restriction Exercise, BFR-TThe intervention comprises of 12 weeks of blood flow restriction exercise in weeks 1-12 after injury. Three weekly exercise sessions are performed. Six supervised sessions are provided during the 12 weeks. Blood flow restriction of 80% of the limb occlusion pressure required to fully restrict the arterial blood flow is employed. The intervention comprises three exercises: Seated leg extension, standing knee flexion, and seated heel-rise performed at home as an adjunct to usual care treatment. Each exercise is performed in four sets of 30, 15, 15, +1 repetitions, with the fourth set (+1) being as many repetitions as possible. Pause in between sets is 30 seconds. Pause in between exercises are 120 seconds. In weeks 13-24, patients in this arm follow usual care treatment. | Other | Early initiated Blood Flow Restriction Exercise |
| Late exercise with partial Blood Flow RestrictionAlso: BFR, BFRE, Blood Flow Restriction Exercise, BFR-TThe intervention comprises of 12 weeks of blood flow restriction exercise in weeks 13-24 after injury. Three weekly exercise sessions are performed. Six supervised sessions are provided during the 12 weeks. Blood flow restriction of 80% of the limb occlusion pressure required to fully restrict the arterial blood flow is employed. The intervention comprises three exercises: Leg press in machine, heel-rise in machine, knee flexion in machine performed at training facilities as an adjunct to usual care treatment. If facilities are unavailable, three home-based exercises will be provided. Each exercise, regardless of study arm, is performed in four sets of 30, 15, 15, +1 repetitions, with the fourth set (+1) being as many repetitions as possible. In weeks 1-12, patients in this arm follow usual care treatment. | Other | Late initiated Blood Flow Restriction Exercise |
Primary outcome
Single-leg heel-rise test
Time frame: Primary outcome at 13 week test. Measured as a secondary outcome at 25 week test.
Patient's ability to perform a Single-Leg Heel-rise, defined as the ability to raise the heel of the injured leg at least 2 cm while keeping the knee straight. The test is performed with patients standing on a flat surface with the ankle in a neutral position. Patients will be allowed to keep their balance by lightly touching a wall.
Achilles tendon Total Rupture Score (ATRS)
Time frame: Primary outcome at 25 week test. It is also measured at baseline through recall of the pre-injury condition and at the 13 week test as a secondary outcome aswell as at 12 month follow-up.
The ATRS is a validated patient-reported, injury-specific questionnaire regarding physical activity and symptoms. The ATRS consists of 10 items scored from 0 (major limitations) to 10 (no limitations), resulting in a score between 0 (worst) to 100 (best).
9 secondary outcomes
30 seconds unilateral Sit to Stand test
Time frame: The test will be performed on both legs at 13 week test and 25 test.
Calf circumference
Time frame: The measurement will be performed on both legs at 13 week test and 25 test.
Thigh circumference
Time frame: The measurement will be performed on both legs at 13 week test and 25 test.
Achilles tendon elongation (ATRA)
Time frame: The test will be performed on both legs at 13 week test and 25 test.
Single-leg heel-rise height
Time frame: The test will be performed on both legs at 13 week test and 25 week test.
Single-leg heel-rise endurance test
Time frame: The test will be performed on both legs at 25 week test.
Tampa Scale of Kinesiophobia 13-items (TSK-13)
Time frame: TSK-13 is measured at baseline, 13 week test, 25 test and at 12 month follow-up.
International Physical Activity Questionnaire-short form (IPAQ-SF)
Time frame: IPAQ-SF is measured at baseline through recall of pre-injury condition, 13 week test, 25 week test and at 12 month follow-up.
Adverse events
Time frame: Measured continously, and evaluated at 13 week test , 25 week test and at 12 month follow-up.
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 30 Oct 2026.
- Individual participant dataSharing planned: Yes. Anonymised patient-level data will be made available if required by the scientific journal, in which the results of the trial are published. Additionally, researchers presenting a justified cause for receiving the data can obtain it after a data access agreement has been signed.
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Achilles Non-SNIS REGENETEN
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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.
Andreas Bentzen, MHSc principal investigator
University of Aarhus
Inger Mechlenburg, DMSc study director
University of Aarhus
Per H. Gundtoft, MD, PhD study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early exercise with partial Blood Flow Restriction and Late exercise with partial Blood Flow Restriction in people with Achilles Tendon Rupture, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 9 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 Andreas Bentzen, MHSc (4553109112, andreas.bentzen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-leg heel-rise test (time frame: Primary outcome at 13 week test. Measured as a secondary outcome at 25 week test.). The study lists 2 primary outcomes in all. 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 30 Oct 2026.