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

Official title

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

Overview

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.

Interventions

• Device Low-intensity resistance exercise 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), performing 4 sets of 30, 15, 15, 15 repetitions with 30 seconds of rest between sets.
• Device Low-intensity resistance exercise with moderate arterial occlusion pressure and fixed pressure.
  A single quadriceps extension exercise at 30% of 1RM with fixed occlusion at 50% of limb occlusion pressure (LOP), performing 4 sets of 30, 15, 15, 15 repetitions with 30 seconds of rest between sets.
• Device Moderate-intensity resistance exercise with low arterial occlusion pressure and dynamic pressure.
  A single quadriceps extension exercise at 50% of 1RM with dynamic occlusion at 30% of limb occlusion pressure (LOP), performing 4 sets of 30, 15, 15, 15 repetitions with 30 seconds of rest between sets.
• Device Moderate-intensity resistance exercise with low arterial occlusion pressure and fixed pressure.
  A single quadriceps extension exercise at 50% of 1RM with a fixed occlusion of 30% of the limb occlusion pressure (LOP), performing 4 sets of 30, 15, 15, 15 repetitions with 30 seconds of rest between sets.
• Device Low-intensity resistance exercise with high arterial occlusion pressure and dynamic pressure.
  A single quadriceps extension exercise at 15% of 1RM with a dynamic occlusion of 80% of the limb occlusion pressure (LOP), performing 4 sets of 30, 15, 15, 15 repetitions with 30 seconds of rest between sets.
• Device Low-intensity resistance exercise with high arterial occlusion pressure and fixed pressure.
  A single quadriceps extension exercise at 15% of 1RM with a fixed occlusion of 80% of the limb occlusion pressure (LOP), performing 4 sets of 30, 15, 15, 15 repetitions with 30 seconds of rest between sets.

Primary outcome measures

• Pain intensity at rest (Visual Analogue Scale, 0-10) [Time frame: Periprocedural]

Secondary outcome measures (7)

• Pressure pain threshold [Time frame: Periprocedural]
• Perceived exertion scale (The BORG CR10 Scale) [Time frame: Periprocedural]
• Surface electromyography [Time frame: Periprocedural]
• Occurrence of adverse effects [Time frame: Immediately after the intervention, 72 hours later, and two weeks after the study ended.]
• Kinesiophobia (The Tampa Scale for Kinesiophobia) [Time frame: Baseline]
• Pain catastrophizing [Time frame: Baseline]
• Functional Measure (Western Ontario and McMaster Universities Osteoarthritis Index) [Time frame: Baseline]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• University of Valencia — Valencia

Identifiers

NCT: NCT07316933 · 2025-FIS-3955989

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗