The effectiveness of low-load Blood flow restriction Exercise in patients with an acute Achilles tendon rupture treated Non-surgically (BEAN): Protocol for a randomized controlled trial

This is an assessor-blinded, randomized, controlled multicenter trial with patients assigned in a 1:1 ratio to two parallel groups, that either receive BFRE in weeks 1-12 followed by usual care in weeks 13-24, or receive usual care in weeks 1-12 followed by BFRE in weeks 13-24. The BFRE program is performed three times weekly on the injured leg at 80 % of the pressure required to fully restrict the arterial blood flow. Post-intervention tests are conducted in week 13, comparing early BFRE with usual care, and in week 25, comparing early BFRE with late BFRE. At the 13-week evaluation, the primary outcome is the Single-Leg Heel-Rise test which assesses the patient's ability to raise the heel of the injured leg a minimum of 2 cm. At the 25-week evaluation, the primary outcome is the Achilles tendon Total Rupture Score which assesses the patient's self-reported symptoms and physical ability.