Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434272
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Blood Flow Restriction Exercise in Patients with an Achilles Tendon Rupture
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
The Effectiveness of Low-load Blood Flow Restriction Exercise in Patients with an Acute Achilles Tendon Rupture Treated Non-surgically
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEAN
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
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 11 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 patients 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 patients 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
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 patients 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None