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Идёт набор NCT07128030

Moderate-Intensity Exercise and Pain Sensitization in Breast Cancer Survivors: A Case-Based Study

Без фазы С лечением Exercise Training Breast Cancer Pain Management

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: Exercise.
Кому может быть актуально
Состояния в реестре: Exercise Training, Breast Cancer, Pain Management. Базовые параметры: Без ограничений · Женщины.
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

The aim of this study was to evaluate the feasibility, safety, and acceptability of a supervised, combined moderate-intensity aerobic and resistance training program designed to reduce pain sensitization in BCS with persistent pain. Secondary objectives included assessing changes in pain intensity, somatosensory sensitivity, and temporal summation, while tertiary objectives focused on improvements in quality of life and functional capacity.

Вмешательства

  • Другое Exercise
    The experimental group completed a five-week supervised program combining moderate-intensity aerobic and resistance training (150 min/week). Intensity was monitored using the Borg and OMNI-Res scales after familiarization sessions. Adherence was encouraged through reminders, motivational messages, and follow-ups. Unlike prior studies, this intervention focused specifically on neurophysiological pain modulation. Sessions included step-based aerobic exercises and resistance training with elastic b

Первичные конечные точки

  • Adherence by Tolerance: number of incomplete sessions [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Tolerance: number of sessions at moderate intensity [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Tolerance: number of participants completing at moderate intensity [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Tolerance: number of progressions during the program [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Tolerance: final progression level reached [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Motivation: number of absences [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Motivation: percentage of sessions recovered after absence [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Motivation: number of dropouts [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Motivation: number of presence of positive sensations [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Motivation: number of occurrence of adverse effects [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
Вторичные конечные точки (11)
  • Brief Pain Inventory (BPI) [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Numerical Rating Scale (NRS) [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • SENSORIMOTOR CHARACTERISTICS: HANDGRIP STRENGTH [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Somatosensorial status (QST): MECHANICAL DETECTION THRESHOLD (MDT) [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Somatosensorial status (QST): MECHANICAL PAIN THRESHOLD (MPT) [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Somatosensorial status (QST): PAIN FACILITATION [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Somatosensorial status (QST): PRESSURE PAIN THRESHOLD (PPT) [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Physical activity was assessed using the Global Physical Activity Questionnaire (GPAQ) [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module (EORTC QLQ-BR23). [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • CARDIOPULMONARY FITNESS [Срок оценки: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]

Критерии участия

Критерии включения

  • Adult women diagnosed with stage I-III breast cancer
  • Completion of active treatment (surgery, chemotherapy, and/or radiotherapy) at least 6 months prior to enrollment
  • Presence of persistent pain or altered sensation in the upper quadrant of the affected limb related to oncologic treatment

Критерии исключения

  • Bilateral breast cancer
  • Locoregional recurrence
  • Other malignancies
  • Pre-existing pain not related to cancer treatment
  • Neurological or cognitive disorders
  • Non-Spanish speakers
  • Contraindications to moderate-intensity physical activity

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Испания · 1 центр
  • Universidad Rey Juan Carlos — Madrid

Идентификаторы

NCT: NCT07128030 · EDCM

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗