Acute Effects of Blood Flow Restriction Training to Failure on Hypoalgesia in Patients With Severe Knee Osteoarthritis Using Dynamic or Fixed Occlusion Pressure

University of Valencia

Status: Not yet enrolling

Conditions: Severe Knee Osteoarthritis

Treatments: Device: Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and fixed pressure.; Device: Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and dynamic pressure.

Study type: Interventional

Funder types: Other

Identifiers

NCT07300384

2025-FIS-3957418

Details and patient eligibility

About

This study aims to compare the acute effects on hypoalgesia of training to failure using blood flow restriction (BFR) with dynamic occlusion versus BFR with fixed occlusion in patients with severe gonarthrosis. Two different training conditions will be performed with varying levels of blood flow occlusion (%BFR) and percentage of load (%RM): 1) 30% RM and 50% BFR with dynamic pressure; 2) 30% RM and 50% BFR with fixed pressure. Each participant will complete two individual sessions under different training conditions, randomly assigned with a 72-hour interval between sessions.

Enrollment: 45 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 50 and 85 years
• Diagnosis of severe gonarthrosis according to the clinical and radiographic criteria of the American College of Rheumatology guidelines.
• On the waiting list for unilateral total knee replacement (TKR) surgery

Exclusion criteria

• Pain in the contralateral leg with an intensity ≥80/100 mm on the visual analog scale (VAS) during daily activities.
• Previous hip or knee replacement surgery and osteotomy within the last year.
• Autoimmune arthritis
• Medical conditions that contraindicate exercise.
• Participation in exercise programs (>2 days/week with training at intensities of 10-15 1RM) in the previous six months.
• History of stroke, brain surgery, major depression, or self-reported cognitive impairment that could affect performance in the study.
• Cardiovascular, thrombotic, or vascular risk factors (uncontrolled hypertension, peripheral arterial disease, history of deep vein thrombosis or pulmonary embolism, heart failure, severe varicose veins, or uncontrolled anticoagulant therapy).
• Skin or local alterations at the cuff application site (ulcers, open wounds, infections, lymphedema, or severe edema).
• Inability to communicate normally or with impaired communication skills.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

45 participants in 2 patient groups

Exercise to failure under low load resistance with moderate blood occlusion and dynamic pressure.

Experimental group

Description:

A single exercise session to failure, 30% of maximum repetition, 50% blood occlusion and dynamic pressure.

Treatment:

Device: Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and dynamic pressure.

Exercise to failure under low load resistance with moderate blood occlusion and fixed pressure.

Experimental group

Description:

A single exercise session to failure, 30% of maximum repetition, 50% blood occlusion and fixed pressure.

Treatment:

Device: Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and fixed pressure.