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Набор скоро начнётся NCT07583719

Effects of Moderate-intensity Interval Aerobic Exercise (MIIAE) on Inflammatory, Immune, Metabolic, Physical Fitness, and Quality of Life Parameters in Breast Cancer Patients Undergoing Radiotherapy.

Без фазы С лечением Radiotherapy Inflamation Immune System Physical Fitness

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: Moderate-Intensity Interval Aerobic Exercise.
Кому может быть актуально
Состояния в реестре: Radiotherapy, Inflamation, Immune System, Physical Fitness. Базовые параметры: 20 лет — 65 лет · 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Breast cancer and its treatment with radiotherapy may be associated with systemic inflammatory, hematological, cardiac, body composition, functional and quality-of-life alterations. Exercise has emerged as a non-pharmacological strategy with potential benefits during oncological treatment; however, further evidence is needed regarding the effects of supervised moderate-intensity interval aerobic exercise during radiotherapy. This randomized controlled trial aims to evaluate the effects of a supervised moderate-intensity interval aerobic exercise programme on systemic inflammatory and immune-derived hematological indices, cardiac biomarkers, body composition, muscle strength, lower-limb power, sleep quality and breast cancer-specific quality of life in women with breast cancer undergoing radiotherapy. Participants will be allocated to either an experimental group performing supervised moderate-intensity interval aerobic exercise during radiotherapy or to a control group receiving usual care without structured exercise during the study period. Outcomes will be assessed at baseline and after completion of the intervention period.

Вмешательства

  • Другое Moderate-Intensity Interval Aerobic Exercise
    Structured and supervised aerobic exercise intervention based on moderate-intensity interval training. The programme includes repeated aerobic exercise bouts interspersed with recovery periods. Exercise intensity is individually prescribed and adjusted according to baseline physiological assessment, including blood lactate response, perceived exertion and clinical tolerance. The intervention is delivered during the radiotherapy treatment period as an adjunct to standard oncological care.

Первичные конечные точки

  • Systemic Immune-Inflammation Index (SII) [Срок оценки: Baseline (pre-intervention) and immediately after intervention]
  • Neutrophil-to-Lymphocyte Ratio (NLR) [Срок оценки: Baseline (pre-intervention) and immediately after intervention]
  • Platelet Count [Срок оценки: Baseline (pre-intervention) and immediately after intervention]
  • Neutrophil Count [Срок оценки: Baseline (pre-intervention) and immediately after intervention]
  • Lymphocyte Count [Срок оценки: Baseline (pre-intervention) and immediately after intervention]
  • NT-proBNP [Срок оценки: Baseline (pre-intervention) and immediately after intervention]
  • High-Sensitivity Troponin I [Срок оценки: Baseline (pre-intervention) and immediately after intervention]
  • Body Weight [Срок оценки: Baseline (pre-intervention) and immediately after intervention]
  • Phase angle [Срок оценки: Baseline (pre-intervention) and immediately after intervention]
  • Fat Mass [Срок оценки: Baseline (pre-intervention) and immediately after intervention]

Критерии участия

Критерии включения

  • Women aged between 20 and 65 years.
  • Clinical diagnosis of breast cancer (Stage I-III).
  • Patients who have undergone lumpectomy or mastectomy.
  • Scheduled to start radiotherapy treatment.
  • Sedentary lifestyle according to international physical activity guidelines.
  • Ability to understand and follow instructions.
  • Ability to provide written informed consent.

Критерии исключения

  • Presence of infectious disease.
  • Cardiovascular or respiratory disease.
  • Metastatic disease.
  • Uncontrolled diabetes mellitus.
  • Neuropathy.
  • Physically active individuals meeting WHO physical activity recommendations.
  • Participation in an exercise intervention program within the last 3 months.
  • Any condition that, in the opinion of the research team, may compromise safety or participation.

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
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07583719 · EIMICM1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗