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Clinical-randomized Trial of the Effect of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Anterior Cruciate Ligament Reconstruction

Clinical-randomized Trial of the Effect of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Anterior Cruciate Ligament Reconstruction

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07043569
Enrollment
30
Registered
2025-06-29
Start date
2025-06-20
Completion date
2026-12-31
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL - Anterior Cruciate Ligament Rupture

Brief summary

With the intention of improving rehabilitation after anterior cruciate ligament reconstruction, the present project investigates the influence of a targeted strength and blood flow restriction training intervention (BFR training) on the regeneration of muscle mass, strength and functionality of the knee joint. BFR training is characterized by the combination of external venous vascular occlusion with light strength training and still enables users to achieve gains in muscle mass and strength that are comparable to training with high mechanical loads. The positive effects of BFR training in the course of knee arthroplasty have already been demonstrated by our working group as a prehabilitative approach, i.e. as a training intervention prior to surgery. In the present project, the framework conditions of outpatient rehabilitation at the Bonn Center for Outpatient Rehabilitation will now be used to prove whether sports science-controlled strength and BFR training has a similar effect in the postoperative rehabilitation phase. The interventions are carried out as part of the exercise therapy units in outpatient rehabilitation ETM01 in accordance with the S2k guideline on anterior cruciate ligament rupture. Strength and BFR training in medical training therapy supplements the daily exercise therapy to ensure implementation in the rehabilitation process in line with the guidelines.

Interventions

OTHERResistance Training with Sham-BFR

The exercise protocol provides for units of approx. 25 minutes of BFR training five times a week as part of medical training therapy. Based on the initial strength measurements prior to rehabilitation, the training phase of the intervention group starts with 30% of the 1RM (calculated from the force-velocity profile) and 70% LOP in the operated leg and 75% of the 1RM (calculated from the force-velocity profile) in the unoperated leg. The patients are randomized into 2 groups: 1) intervention group, which receives a daily intervention with an occlusion pressure and the 2) control group, which receives a daily Sham-BFR intervention with an occlusion pressure of 20mmHg.

The exercise protocol provides for units of approx. 25 minutes of BFR training five times a week as part of medical training therapy. Based on the initial strength measurements prior to rehabilitation, the training phase of the intervention group starts with 30% of the 1RM (calculated from the force-velocity profile) and 70% LOP in the operated leg and 75% of the 1RM (calculated from the force-velocity profile) in the unoperated leg. The patients are randomized into 2 groups: 1) intervention group, which receives a daily intervention with an occlusion pressure and the 2) control group, which receives a daily Sham-BFR intervention with an occlusion pressure of 20mmHg.

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ACL reconstruction * Ability to take part in an outpatient rehabilitation

Exclusion criteria

* Sickle Cell anemia * iatrogenic changes in the vessels of the lower limbs (stents, bypasses) * inflammation of the lower extremities

Design outcomes

Primary

MeasureTime frameDescription
Muscle Strength (N)Pre- (before Rehabilitation) to Post-Rehabilitation (immediately after three weeks of exercise intervention up to 1 year follow up)isoemtric maximal strength of both legs will assessed on a isokinetic leg press.

Countries

Germany

Contacts

Primary ContactAlexander Franz, Dr. med., B.Sc.
alexander.franz@ukbonn.de+491703750718

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026