Acute Exercise Responses With Blood Flow Restriction Under Dynamic Pressure Compared to Fixed Pressure in Patients With Severe Gonarthrosis

University of Valencia

Status: Not yet enrolling

Conditions: Severe Knee Osteoarthritis

Treatments: Device: Low-intensity resistance exercise with high arterial occlusion pressure and fixed pressure.; Device: Moderate-intensity resistance exercise with low arterial occlusion pressure and fixed pressure.; Device: Low-intensity resistance exercise with high arterial occlusion pressure and dynamic pressure.; Device: Low-intensity resistance exercise with moderate arterial occlusion pressure and fixed pressure.; Device: Low-intensity resistance exercise with moderate arterial occlusion pressure and dynamic pressure.; Device: Moderate-intensity resistance exercise with low arterial occlusion pressure and dynamic pressure.

Study type: Interventional

Funder types: Other

Identifiers

NCT07316933

2025-FIS-3955989

Details and patient eligibility

About

This study aims to evaluate the acute effects of blood flow restriction (BFR) training on hypoalgesia and neuromuscular responses in patients with severe gonarthrosis by comparing the application of pressure with a dynamic versus a fixed configuration. There will be six different training conditions 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; 3) 50% RM and 50% BFR with dynamic pressure; 4) 50% RM and 50% BFR with fixed pressure; 5) 30% RM and 80% BFR with dynamic pressure; 6) 30% RM and 80% BFR with fixed pressure.

Each participant will complete six individual sessions under different training conditions, assigned in a random order with a 72-hour interval between each session.

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

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45 participants in 6 patient groups

Low-load resistance exercise with moderate blood occlusion and dynamic pressure.

Experimental group

Description:

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

Treatment:

Device: Moderate-intensity resistance exercise with low arterial occlusion pressure and dynamic pressure.

Low-load resistance exercise with moderate blood occlusion and fixed pressure.

Experimental group

Description:

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

Treatment:

Device: Moderate-intensity resistance exercise with low arterial occlusion pressure and fixed pressure.

Moderate-load resistance exercise with low blood occlusion and dynamic pressure.

Experimental group

Description:

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

Treatment:

Device: Low-intensity resistance exercise with high arterial occlusion pressure and dynamic pressure.

Moderate-load resistance exercise with low blood occlusion and fixed pressure.

Experimental group

Description:

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

Treatment:

Device: Low-intensity resistance exercise with high arterial occlusion pressure and fixed pressure.

Low-load resistance exercise with high blood occlusion and dynamic pressure

Experimental group

Description:

A single session of exercise, 15% repetition maximum, 80% blood occlusion, and dynamic pressure

Treatment:

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

Low-load resistance exercise with high blood occlusion and fixed pressure

Experimental group

Description:

A single session of exercise, 15% repetition maximum, 80% blood occlusion, and fixed pressure

Treatment:

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