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

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

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 Overview

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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-load resistance exercise with moderate blood occlusion and dynamic pressure.; A single session of exercise, 30% repetition maximum, 50% blood occlusion, and dynamic pressure	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.
Experimental: Low-load resistance exercise with moderate blood occlusion and fixed pressure.; A single session of exercise, 30% repetition maximum, 50% blood occlusion, and fixed pressure	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.
Experimental: Moderate-load resistance exercise with low blood occlusion and dynamic pressure.; A single session of exercise, 50% repetition maximum, 30% blood occlusion, and dynamic pressure	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.
Experimental: Moderate-load resistance exercise with low blood occlusion and fixed pressure.; A single session of exercise, 50% repetition maximum, 30% blood occlusion, and fixed pressure	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.
Experimental: Low-load resistance exercise with high blood occlusion and dynamic pressure; A single session of exercise, 15% repetition maximum, 80% blood occlusion, and dynamic pressure	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.
Experimental: Low-load resistance exercise with high blood occlusion and fixed pressure; A single session of exercise, 15% repetition maximum, 80% blood occlusion, and fixed pressure	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.

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
Surface electromyography	Surface electromyography for the study of muscle recruitment (vastus medialis and vastus lateralis)	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.	Baseline
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	Baseline
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.	Baseline

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 23, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• 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; blood 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-3955989

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