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Идёт набор NCT07300384

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

Без фазы С лечением Severe Knee Osteoarthritis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 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..
Кому может быть актуально
Состояния в реестре: Severe Knee Osteoarthritis. Базовые параметры: 50 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
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Обзор

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.

Вмешательства

  • Устройство 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.
  • Устройство 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.

Первичные конечные точки

  • Pain intensity at rest (Visual Analogue Scale, 0-10) [Срок оценки: Periprocedural]
Вторичные конечные точки (7)
  • Pressure pain threshold [Срок оценки: Periprocedural]
  • Perceived exertion scale (The BORG CR10 Scale) [Срок оценки: Periprocedural]
  • Occurrence of adverse effects [Срок оценки: Immediately after the intervention, 72 hours later, and two weeks after the study ended]
  • Kinesiophobia (The Tampa Scale for Kinesiophobia) [Срок оценки: Before the intervention and at the end of the study]
  • Pain catastrophizing [Срок оценки: Before the intervention and at the end of the study]
  • Functional Measure (Western Ontario and McMaster Universities Osteoarthritis Index) [Срок оценки: Before the intervention and at the end of the study]
  • Number of Repetitions Performed [Срок оценки: Periprocedural]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Испания · 2 центра
  • Faculty of Physiotherapy, University of Valencia — Valencia
  • University of Valencia — Valencia

Идентификаторы

NCT: NCT07300384 · 2025-FIS-3957418

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗