Effects of Blood Flow Restriction Combined With Electrostimulation After Knee Arthroplasty

University of Pavia

Status: Active, not recruiting

Conditions: Osteo Arthritis Knee

Treatments: Device: Blood flow restriction combined with electrostimulation.

Study type: Interventional

Funder types: Other

Identifiers

NCT07141316

BFR01

Details and patient eligibility

About

The goal of this clinical trial is to learn whether blood flow restriction (BFR) combined with electrostimulation (ES) can improve the postoperative course of patients undergoing total knee arthroplasty. The main questions it aims to answer are:

Immediately after surgery, do BFR combined with ES increase quadriceps strength? Do they also improve the functional abilities of patients? Researchers will compare BFR combined with ES to ES alone, to see if there are differences.

Participants will carry out a daily session of BFR+ ES or ES alone for six working days after surgery

Full description

Blood flow restriction (BFR) is an innovative treatment technique that involves the application of controlled pressure, through a special sleeve, to partially limit arterial flow and completely prevent venous outflow in the active muscles during exercise.

This approach is based on a hemodynamic modulation that induces a hypoxic environment at the muscle level, favoring the activation of metabolic processes and cellular mechanisms responsible for positive adaptations, such as the increase in protein synthesis, the promotion of muscle hypertrophy, aerobic capacity and the management of pain perception.

In rehabilitation, blood flow restriction treatment has been recognized as an effective strategy to promote functional recovery, offering benefits comparable to those of traditional treatment with high loads. This methodology is particularly useful in contexts where the use of high loads is contraindicated, such as in patients with orthopaedic limitations, with muscle weakness or undergoing surgery because it induces significant muscle adaptation even with low loads. The latest evidence indicates that reduced Limb occlusion pressures (LOP) (40% of blood pressure) achieve similar benefits to high pressures (80%) and are appreciated by patients. In the middle-aged and elderly population, the efficacy of BFR has been widely demonstrated but the studies that have investigated its effects on patients undergoing Knee Arthroplasty (KA) are few, of poor quality and carried out in the advanced rehabilitation phase. Patients undergoing KA at the "Città di Pavia" University Hospital, from the first post-operative day, perform a standard rehabilitation program including: passive mobilization, assisted active exercises, indirect electrostimulation and gait re-education. Although the results are positive, in the first few days, there are cases in which problems such as loss of muscle strength and functionality and persistence of pain occur; these sequelae are in agreement with the most recent literature.

Based on the rationale, the study aims to evaluate, in a group of patients undergoing KA, the short-term effects of electrostimulation combined with BFR and compare them with those of a group that will carry out the standard treatment. The treatment steps will be as follows:

I. positioning of electrodes for electrostimulation on the quadriceps of the operated limb; II. application of the pneumatic band to the root of the thigh and LOP setting; III. programmazione dei parametri della BFR (LOP, 50%) (Occlusion time, 6 periods of 4 minutes of occlusion and 1 minutes of rest); IV. simultaneous start-up of the two devices.

Enrollment: 60 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective knee arthroplasty surgery

Exclusion criteria

• obesity (body mass index equal to or greater than 30 Kg/m2);
• concomitant orthopaedic or neurological pathologies (other than the pathology for which arthroprosthesis has been indicated) that modify walking capacity;
• pathologies that modify the balance (neurological and/or vestibular);
• contraindications to the use of medical equipment used in the practice;
• inability to understand and sign informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Blood flow restriction and Electrostimulation (GEL)

Experimental group

Description:

For six working days, starting from the third day after surgery, he will perform 30 minutes of blood flow restriction once a day during electrostimulation of the quadriceps of the operated limb.

Treatment:

Device: Blood flow restriction combined with electrostimulation.

Electrostimulation alone (GST)

No Intervention group

Description:

For six working days, starting from the third day after surgery, he will perform 30 minutes of electrostimulation of the quadriceps of the operated limb once a day