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Набор скоро начнётся NCT07427979

Sex Differences in Exercise-Induced Hypoalgesia

Без фазы С лечением Healthy Adult

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: Aerobic exercise using cycle ergometer.
Кому может быть актуально
Состояния в реестре: Healthy Adult. Базовые параметры: 18 лет — 65 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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Официальное название

Sex Differences in Exercise-Induced Hypoalgesia Following Aerobic Exercise Using a Lower-Limb Cycle Ergometer: A Quasi-Experimental Study

Обзор

Exercise-induced hypoalgesia (EIH) refers to the reduction in pain sensitivity following acute exercise. Although aerobic exercise has been shown to induce hypoalgesia in healthy individuals, it remains unclear whether the magnitude of this response differs between men and women. This quasi-experimental study aims to evaluate sex differences in pressure pain thresholds following a standardized aerobic exercise protocol using a lower-limb cycle ergometer. Pressure pain thresholds will be assessed before exercise, immediately after exercise, and 30 minutes after exercise in healthy adults aged 18 to 65 years. The findings of this study may contribute to improving individualized exercise prescription strategies based on sex differences in pain modulation.

Подробное описание

Exercise-induced hypoalgesia (EIH) is characterized by a transient reduction in pain sensitivity following acute physical exercise, measurable through pressure pain thresholds (PPTs). Aerobic exercise has been consistently shown to increase PPTs in healthy individuals through activation of endogenous pain inhibitory mechanisms, including opioid and non-opioid pathways.

However, the influence of biological sex on EIH remains unclear, and understanding potential differences between men and women could have important implications for exercise prescription in clinical and healthy populations.

This quasi-experimental study will include healthy male and female participants aged 18-65 years. Participants will undergo a single session of aerobic exercise on a lower-limb cycle ergometer at 70% heart rate reserve for 30 minutes.

Pressure pain thresholds will be assessed using a validated digital pressure algometer at:

* Quadriceps muscle (local site) * Lateral epicondyle region (remote site)

Measurements will be performed at three time points:

* Pre-exercise * Immediately post-exercise * 30 minutes post-exercise

The primary analysis will compare changes in pressure pain thresholds between men and women using ANCOVA models adjusting for baseline values.

Вмешательства

  • Поведенческое Aerobic exercise using cycle ergometer
    Participants will perform a 30-minute aerobic exercise protocol using a lower-limb cycle ergometer at 70% heart rate reserve. The protocol includes: * 5-minute warm-up * 20-minute exercise at target intensity * 5-minute cool-down Heart rate will be monitored continuously using a validated heart rate monitor.

Первичные конечные точки

  • Pressure Pain Threshold at Quadriceps [Срок оценки: Pre-exercise, immediately post-exercise, and 30 minutes post-exercise]
Вторичные конечные точки (1)
  • Pressure Pain Threshold at Lateral Epicondyle [Срок оценки: Pre-exercise, immediately post-exercise, and 30 minutes post-exercise]

Критерии участия

Критерии включения

  • Healthy male and female adults
  • Age between 18 and 65 years
  • Able to perform moderate-to-vigorous aerobic exercise
  • Able to understand study procedures
  • Cleared for exercise participation using the Physical Activity Readiness Questionnaire (PAR-Q).

Критерии исключения

  • Cardiovascular, respiratory, neurological, or metabolic diseases contraindicating exercise
  • Current musculoskeletal pain or injury
  • Analgesic medication use within 24 hours prior to testing
  • Vigorous exercise within 24 hours prior to testing
  • Any contraindication to aerobic exercise

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
Фундаментальное исследование

Центры проведения

Испания · 1 центр
  • Centro Superior de Estudios Universitarios La Salle — Madrid

Публикации

  • Awali, A., Nevsimal, R., O'Melia, S., Alsouhibani, A., & Bement, M. Hoeger. (2019). (305) The Contribution of Experimental Pain to the Sex Differences in Exercise-Induced Hypoalgesia. The Journal of Pain, 20(4, Supplement), S50. https://doi.org/10.1016/j.jpain.2019.01.462 Belavy, Daniel L., Oosterwijck, Jessica Van, Clarkson, Matthew, Dhondt, Evy, Mundell, Niamh L., Miller, Clint T., & Owen, Patri

Идентификаторы

NCT: NCT07427979 · CSEULS-PI-002/2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗