Acute Responses to Different Blood Flow Restriction Exercise Configurations With Dynamic Pressure Compared to Fixed Pressure in Patients With Severe Gonarthrosis
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Valencia
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Pain intensity at rest (Visual Analogue Scale, 0-10)
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Pain intensity at rest (Visual Analogue Scale, 0-10)
Time Frame: Periprocedural
Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.
Secondary Outcomes
- Pressure pain threshold(Periprocedural)
- Perceived exertion scale (The BORG CR10 Scale)(Periprocedural)
- Functional Measure (Western Ontario and McMaster Universities Osteoarthritis Index)(Baseline)
- Surface electromyography(Periprocedural)
- Occurrence of adverse effects(Immediately after the intervention, 72 hours later, and two weeks after the study ended.)
- Pain catastrophizing(Baseline)
- Kinesiophobia (The Tampa Scale for Kinesiophobia)(Baseline)
Investigators
Adrián Escriche Escuder
Assistant professor
University of Valencia