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

Recruiting · NCT07316933 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Valencia

View the official record on ClinicalTrials.gov →

Osteoarthritis

Interventions studied

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

What this trial is 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.

Who can take part

Age range

50 Years to 85 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

1 location listed.

University of Valencia - Valencia, Valencia, Spain

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →