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

NCT ID: NCT07300384

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Severe Knee Osteoarthritis

Keywords

bood flow restriction; exercise; gonarthrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

A single quadriceps extension exercise at 30% of 1 repetition maximum (1RM) with dynamic occlusion at 50% of limb occlusion pressure (LOP). The exercise protocol will consist of 4 sets to muscle failure with 30 seconds of rest between sets and a continuous level of occlusion.

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

A single quadriceps extension exercise at 30% of 1 repetition maximum (1RM) with fixed occlusion at 50% of limb occlusion pressure (LOP). The exercise protocol will consist of 4 sets to muscle failure with 30 seconds of rest between sets and a continuous level of occlusion.

Interventions

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

A single quadriceps extension exercise at 30% of 1 repetition maximum (1RM) with dynamic occlusion at 50% of limb occlusion pressure (LOP). The exercise protocol will consist of 4 sets to muscle failure with 30 seconds of rest between sets and a continuous level of occlusion.

Intervention Type: DEVICE

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

A single quadriceps extension exercise at 30% of 1 repetition maximum (1RM) with fixed occlusion at 50% of limb occlusion pressure (LOP). The exercise protocol will consist of 4 sets to muscle failure with 30 seconds of rest between sets and a continuous level of occlusion.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Adrián Escriche Escuder

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Valencia

Valencia, Valencia, Spain

Countries

Spain

Central Contacts

Adrián Escriche-Escuder, PhD

Role: CONTACT

Phone: +34 963 98 38 55

Email: adrian.escriche@uv.es

Other Identifiers

2025-FIS-3957418

Identifier Type: -

Identifier Source: org_study_id