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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Severe Knee Osteoarthritis
• Intervention / Treatment: Device: Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and dynamic pressure.; Device: Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and fixed pressure.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adrian Escriche-Escuder, PhD; Phone Number: +34 963 98 38 55; Email: adrian.escriche@uv.es

Study Locations

• Spain
  • Valencia
    • Valencia, Valencia, Spain
      • University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity at rest (Visual Analogue Scale, 0-10)	Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure pain threshold	Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer	Periprocedural
Perceived exertion scale (The BORG CR10 Scale)	The BORG CR10 Scale is a subjective tool used to measure the intensity of the perceived exertion of a person during an activity through a rate of perceived exertion (RPE). It is scored on a scale of 0 to 10, where 0 is no exertion and 10 is maximum exertion.	Periprocedural
Occurrence of adverse effects	Occurrence of adverse effects (e.g., pain, delayed onset muscle soreness, sudden weakness of the trained limb, redness or swelling of the trained limb, etc.) by self-report.	Immediately after the intervention, 72 hours later, and two weeks after the study ended
Kinesiophobia (The Tampa Scale for Kinesiophobia)	The Tampa Scale for Kinesiophobia is a questionnaire designed to assess fear of movement and avoidance of physical activity due to pain. It consists of 17 items answered on a scale of 1 (strongly disagree) to 4 (strongly agree), measuring two main factors: fear of movement and activity avoidance. The total score ranges from 17 to 68 points, with higher scores indicating greater kinesophobia.	Before the intervention and at the end of the study
Pain catastrophizing	The Pain Catastrophizing Scale includes 13 items in total (0-52 points) that describe different thoughts and feelings associated with pain. The PCS consists of 5 grades: 0 not at all, 1 a little, 2 moderately, 3 a lot, and 4 always. The participant must mark their situation for each case. Higher scores correspond to higher levels of pain catastrophizing	Before the intervention and at the end of the study
Functional Measure (Western Ontario and McMaster Universities Osteoarthritis Index)	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a questionnaire designed to assess pain, stiffness, and function in patients with knee and hip osteoarthritis. It consists of 24 items, divided into three subscales that assess pain (5 items), stiffness (2 items), and physical function (17 items). Responses are given on a 0-to-4 Likert-type scale, where higher scores indicate greater impairment.	Before the intervention and at the end of the study
Number of Repetitions Performed	The number of maximum repetitions performed in each set will be assessed for each patient	Periprocedural

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Estimated): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: exercise; gonarthrosis; bood flow restriction
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Behavior; Osteoarthritis, Knee; Motor Activity
• Other Study ID Numbers: 2025-FIS-3957418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data that support the findings of this study will be available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No