## Protocol Section
### Identification Module
**NCT ID:** NCT06434272

**Acronym:** BEAN

**Brief Title:** Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture

**Official Title:** The Effectiveness of Low-load Blood Flow Restriction Exercise in Patients With an Acute Achilles Tendon Rupture Treated Non-surgically

#### Organization Study ID Info
**ID:** BEAN (1-10-72-192-23)
#### Organization
**Class:** OTHER
**Full Name:** University of Aarhus
### Status Module
#### Completion Date
**Date:** 2026-01-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-01-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Aarhus University Hospital

**Class:** OTHER

**Name:** Gødstrup Hospital

**Class:** UNKNOWN

**Name:** Regional Hospital Horsens

**Class:** OTHER

**Name:** Aalborg University Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Aarhus

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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 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 to compare BFRE to usual care, and at 25 weeks 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.

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 Module

**Conditions:**

- Achilles Tendon Rupture

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 218

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Receives an intervention in adjunct to usual care in weeks 1-12, and continues with usual care in weeks 13-24.

**Intervention Names:**

- Other: Exercise with partial Blood Flow Restriction

**Label:** Early initiated Blood Flow Restriction Exercise

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Receives usual care in weeks 1-12, and receives an intervention in weeks 13-24.

**Intervention Names:**

- Other: Exercise with partial Blood Flow Restriction

**Label:** Late initiated Blood Flow Restriction Exercise

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Early initiated Blood Flow Restriction Exercise

- Late initiated Blood Flow Restriction Exercise

**Description:** The intervention comprises of 12 weeks of Blood Flow Restriction Exercise (BFRE). 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 epmployed in both interventions arms (Early BFRE and Late BFRE)

The Early BFRE intervention comprises two exercises: Seated leg extension and seated heel-rise, performed at home.

The Late BFRE intervention comprises three exercises: Leg press in machine, heel-rise in machine, knee flexion in machine, performed at training facilities.

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.

Pause in between sets is 30 seconds. Pause in between exercises are 120 seconds.

**Name:** Exercise with partial Blood Flow Restriction

**Other Names:**

- BFR

- BFRE

- Blood Flow Restriction Exercise

- BFR-T

- Blood Floow Restriciton Training

- LL-BFR

- Low Load Blood Flow Restriction

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** ultrasound using the Copenhagen Achilles length measure (CALM) will be used in a subset of the study population to validate the tendon length results.

**Measure:** Copenhagen Achilles Length Measure (CALM)

**Time Frame:** CALM is measured at 13 week test and 25 week test.

**Description:** The Achilles tendon cross-sectional area is measured using ultrasound \[28\] in a subset of the study population.

**Measure:** Tendon cross-sectional area.

**Time Frame:** Tendon cross-sectional area is measured at 13 week test and 25 week test.

#### Primary Outcomes

**Description:** 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.

**Measure:** Single-leg heel-rise test

**Time Frame:** 13 week test

**Description:** 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).

**Measure:** Achilles tendon Total Rupture Score (ATRS)

**Time Frame:** 25 week test

#### Secondary Outcomes

**Description:** 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

**Measure:** 30 seconds unilateral Sit to Stand test

**Time Frame:** The test will be performed on both legs at 13 week test and 25 test.

**Description:** The calf circumference is measured on both legs using a tape measure 15 cm below the medial pal-pable joint line of the knee. Repeated measurements will be made until a consistent measurement is found.

**Measure:** Calf circumference

**Time Frame:** The measurement will be performed on both legs at baseline, 13 week test, and 25 test.

**Description:** Thigh circumference is measured on both legs using a tape measure 10 cm proximal to the apex pa-tella. During measurement patients lay supine on an examination table with knees bent in a 90-degree angle.

**Measure:** Thigh circumference

**Time Frame:** The measurement will be performed on both legs at baseline, 13 week test, and 25 test.

**Description:** 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.

**Measure:** Achilles tendon elongation (ATRA)

**Time Frame:** The test will be performed on both legs at 13 week test and 25 test.

**Description:** The TSK-13 is a 13-item self-reported measure for fear of movement or reinjury \[29\]. It was origi-nally validated for patients with backpain but has previously been used in patients with Achilles tendon rupture.

**Measure:** Tampa Scale of Kinesiophobia 13-items (TSK-13)

**Time Frame:** TSK-13 is measured at baseline, 13 week test, and 25 test.

**Description:** The EQ-5D-5L is a generic self-reported measure for health-related quality of life consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five severity levels each.

**Measure:** EQ-5D-5L

**Time Frame:** EQ-5D-5L is measured at baseline, 13 week test, and 25 week test.

**Description:** 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.

**Measure:** International Physical Activity Questionnaire-short form (IPAQ-SF)

**Time Frame:** IPAQ-SF is measured at baseline (re-call prior to rupture), 13 week test, and 25 week test.

**Description:** Patients' adherence with the exercise sessions (completed sessions) and progression during the inter-vention period will be recorded in self-reported exercise diaries by the patients. . Exercise diaries will also be provided to patients in the control group, to monitor usual care exercise.

**Measure:** Exercise adherence and progression

**Time Frame:** Measured continously, and evaluated at 13 week test and 25 week test.

**Description:** 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.

**Measure:** Adverse events

**Time Frame:** Measured continously, and evaluated at 13 week test and 25 week test.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* aged 18 years or older
* have started initial treatment within 72 hours of Achilles tendon rupture
* understand written and spoken Danish

Exclusion Criteria:

* 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 or corticosteroids within the last six months
* diabetes
* previous diagnosed thrombosis
* no identifiable pulse in the injured leg
* other reasons for exclusion (cognitive deficits, inability to provide informed consent, requiring cast-treatment due to low compliance regarding gradual wedge removal, etc.)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** andreas.bentzen@clin.au.dk

**Name:** Andreas Bentzen, MHSc

**Phone:** (+45) 5310 9112

**Role:** CONTACT

**Contact 2:**

**Email:** inger.mechlenburg@clin.au.dk

**Name:** Inger Mechlenburg, DMSc

**Phone:** (+45) 2167 9062

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** University of Aarhus

**Name:** Andreas Bentzen, MHSc

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Aarhus

**Name:** Inger Mechlenburg, DMSc

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** Aarhus University Hospital

**Name:** Per H. Gundtoft, MD, PhD

**Role:** STUDY_DIRECTOR

**Official 4:**

**Affiliation:** Regional Hospital Horsens

**Name:** Stian L. Jørgensen, PT, PhD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** Data access will be reviewed by the author group. Requesters will be required to sign a data access agreement.

**Description:** 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.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** Data will be available after publication of the trial.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15241

- Name: Rupture

- Relevance: HIGH

- As Found: Rupture

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012421

- Term: Rupture

### Misc Info Module

- Version Holder: 2024-05-31
