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Идёт набор NCT07327593

Exercise Induced Hypoalgesia in Pain-free Stroke and Healthy Populations: a Cohort Study

Без фазы С лечением Stroke Pain Exercise Induced Hypoalgesia

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: Cardiovascular training.
Кому может быть актуально
Состояния в реестре: Stroke, Pain, Exercise Induced Hypoalgesia. Базовые параметры: от 18 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Exercise has shown multiple beneficial effects in both healthy and post-stroke populations. One of these is the acute reduction in sensitivity to painful stimuli, called exercise-induced hypoalgesia (EIH). This phenomenon has been studied since 1979 and has shown improvements in pain thresholds with both aerobic and resistance training in healthy, pain-free populations and different chronic pain conditions. Although there has been extensive research on EIH in healthy populations and those with chronic musculoskeletal pain, surprisingly little attention has been given to individuals with neurological pathologies. Chronic pain is found in more than 50% of patients after stroke, and 70% of affected individuals experience pain on daily activities. Reported prevalences of post-stroke pain (PSP) between different studies, but there is a general consensus that it is an underreported phenomenon. Patients with pain experience greater cognitive and functional decline, fatigue, depression and lower quality of life. Multiple factors contribute to PSP, and various approaches exist to treat all the variables influencing it. This study aims to compare the effects of exercise on pain perception in healthy individuals and stroke patients without pain, using the same cardiovascular training protocol, to better understand the mechanisms of EIH and its maintenance after stroke, ultimately aiming to improve the treatment of people with stroke.

Вмешательства

  • Другое Cardiovascular training
    The cardiovascular training protocol will consist of a 5-minute warm-up aimed at reaching 70% of maximum heart rate (MHR) followed by 20 minutes of sustained work at this intensity (since maintaining this intensity is difficult, especially in the stroke cohort, we will allow for a margin of ±2-3% of MHR and provide feedback to increase or decrease the heart rate). We will aim to keep the heart rate below 73% of maximum heart rate, maintain blood pressure within safe ranges, and keep the effort l

Первичные конечные точки

  • Pressure pain thresholds [Срок оценки: Before the cardiovacular training, inmediately after the training, and 30 minutes after]
  • Conditioned pain modulation [Срок оценки: Before the cardiovascular training, inmediately after the training and 30 minutes after]

Критерии участия

Критерии включения

Healthy cohort:

  • Age > 18 years
  • No neurological damage
  • No medical conditions that could affect the test

Post-stroke cohort:

  • Age > 18 years
  • Ischemic or hemorrhagic stroke (time since onset > 3 months)

Критерии исключения

Healthy cohort:

  • Any medical condition that could affect the test (respiratory, cardiovascular, metabolic diseases, for example)
  • Pain in any location, of duration > 1 week in the 3 months preceding the trial.

Post-stroke cohort:

  • Unable to participate in the test (no possibility of transfer or active pedaling)
  • Medical contraindication to cardiovascular training for any reason
  • Inability to follow instructions or communicate sensations during training
  • Other neurological pathology, cardiac pathology (unstable angina, arrhythmias, aortic or left ventricular problems, myocarditis, pericarditis), pulmonary pathology that affects the test (pulmonary embolisms, pulmonary hypertension, etc.), renal or metabolic problems (severe renal dysfunction, uncontrolled diabetes, etc.), acute infection or fever, neurosurgery within 6 weeks prior to inclusion in the study
  • Pain in any location, lasting > 1 week in the 3 months prior to the trial.
  • Use of beta-blockers, antidepressants, or any medication that may alter heart rate measurements

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Испания · 2 центра
  • Neuron Madrid Río — Madrid
  • Neuron Nuevos Ministerios — Madrid

Идентификаторы

NCT: NCT07327593 · NeuronRehab

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗