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Effects of Blood Flow Restriction Combined With Electrostimulation After Knee Arthroplasty

Effects of Blood Flow Restriction Combined With Electrostimulation After Knee Arthroplasty: Randomized Controlled Trial

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07141316
Enrollment
60
Registered
2025-08-26
Start date
2025-07-10
Completion date
2026-04-10
Last updated
2025-08-26

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

Conditions

Osteo Arthritis Knee

Keywords

Blood Flow Restriction, Knee Arthroplasty

Brief summary

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

Detailed 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.

Interventions

DEVICEBlood flow restriction combined with electrostimulation.

Participants will perform 30 minutes of blood flow restriction once a day during electrostimulation of the quadriceps of the operated limb.

Sponsors

University of Pavia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Maximum quadriceps strength of the operated limbFrom the second to the tenth day post surgery.Maximum quadriceps strength, measured with a dynamometer and expressed in kilograms

Secondary

MeasureTime frameDescription
Functional CapacitiesFrom the second to the tenth day post surgery.Timed Up and Go test ( seconds) and the 30 Seconds Chair Stand test (number of repetitions) will performed.
Functional StrengthFrom the second to the tenth day post surgery.30 Seconds Chair Stand test (number of repetitions)
Walking autonomyFrom the second to the tenth day post surgery.20 meters walking test (seconds)

Countries

Italy

Outcome results

None listed

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