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Recruiting NCT07300384

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

No phase Interventional Severe Knee Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and dynamic pressure., Low-intensity resistance exercise to failure with moderate arterial occlusion pressure and fixed pressure..
Who it may be relevant to
Registry conditions: Severe Knee Osteoarthritis. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • 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.

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]
  • 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: Before the intervention and at the end of the study]
  • Pain catastrophizing [Time frame: Before the intervention and at the end of the study]
  • Functional Measure (Western Ontario and McMaster Universities Osteoarthritis Index) [Time frame: Before the intervention and at the end of the study]
  • Number of Repetitions Performed [Time frame: Periprocedural]

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 · 2 centers
  • Faculty of Physiotherapy, University of Valencia — Valencia
  • University of Valencia — Valencia

Identifiers

NCT: NCT07300384 · 2025-FIS-3957418

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗