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Набор скоро начнётся NCT06976593

Muscle Oxygen Saturation and Functional Capacity in Breast Cancer Survivors

— Наблюдательное Breast Cancer Survivorship Muscle Oxygenation Near-infrared Spectroscopy Exercise

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: Functional Exercise Testing and Muscle Oxygen Saturation Measurement.
Кому может быть актуально
Состояния в реестре: Breast Cancer Survivorship, Muscle Oxygenation, Near-infrared Spectroscopy, Exercise. Базовые параметры: 30 лет — 70 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Performance Tests in Breast Cancer Survivors

Обзор

This cross-sectional observational study aims to assess muscle oxygen saturation (SmO2) in the intercostal, quadriceps, and triceps surae muscles using near-infrared spectroscopy (NIRS) during functional exercise tests in breast cancer survivors. Participants will be grouped based on their previous cancer treatment: hormonal therapy only or hormonal therapy combined with chemotherapy. Functional performance will be evaluated through the 6-Minute Walk Test, 30-Second Sit-to-Stand Test, and a submaximal treadmill test. The study will analyze differences in muscle oxygenation and performance between groups and explore associations with other functional and clinical parameters.

Подробное описание

This study focuses on evaluating muscle oxygen saturation and physical performance in women who have survived breast cancer. Cancer treatments such as chemotherapy and hormonal therapy can lead to systemic effects, including muscular deconditioning, fatigue, and reduced cardiorespiratory capacity. Near-infrared spectroscopy (NIRS) offers a non-invasive means of assessing SmO2 in real-time, providing insight into oxygen delivery and utilization during exercise.

Participants will undergo three functional tests: the 6-Minute Walk Test, the 30-Second Sit-to-Stand Test, and a submaximal treadmill test. Muscle oxygenation will be measured in three key muscle groups before, during, and after each task. Additional outcomes include functional test performance, respiratory strength, pulmonary function, fatigue perception, and quality of life questionnaires. This study will explore whether prior cancer treatment protocols affect muscle oxygenation and physical function differently, and may inform future rehabilitation strategies tailored to breast cancer survivors.

Вмешательства

  • Диагностический тест Functional Exercise Testing and Muscle Oxygen Saturation Measurement
    Participants will complete three physical performance tests: (1) the 6-Minute Walk Test (6MWT), (2) the 30-Second Sit-to-Stand Test, and (3) a submaximal treadmill test. Muscle oxygen saturation (SmO2) will be continuously monitored during the tests using near-infrared spectroscopy (NIRS) devices placed on the intercostal, quadriceps, and triceps surae muscles. Additional variables such as heart rate, perceived exertion, respiratory pressures, pulmonary function, and fatigue will be assessed dur

Первичные конечные точки

  • Muscle oxygen saturation (%) [Срок оценки: Within a single assessment session (~1 hour)]
Вторичные конечные точки (9)
  • Distance covered in the 6-Minute Walk Test (meters) [Срок оценки: During and immediately after functional assessment session]
  • Number of repetitions in the 30-Second Sit-to-Stand Test [Срок оценки: During and immediately after functional assessment session]
  • Maximal heart rate and recovery rate during treadmill test [Срок оценки: During and immediately after functional assessment session]
  • Lower limb fatigue and perceived exertion (Borg scale) [Срок оценки: During and immediately after functional assessment session]
  • Maximal inspiratory pressures (Pimax) [Срок оценки: During and immediately after functional assessment session]
  • Pulmonary function (FEV1/FEV6 ratio using Vitalograph® COPD-6) [Срок оценки: During and immediately after functional assessment session]
  • Quality of life (EORTC QLQ-C30) European Organisation for Research and Treatment of Cancer [Срок оценки: During and immediately after functional assessment session]
  • Maximal expiratory pressures (Pemax) [Срок оценки: During and immediately after functional assessment session]
  • Quality of life (BR23) [Срок оценки: During and immediately after functional assessment session]

Критерии участия

Критерии включения

  • Women aged 30 to 70 years
  • Clinical history of breast cancer treatment (at least 6 months prior)
  • Completed primary cancer treatment
  • Ability to perform physical tests
  • Signed informed consent

Критерии исключения

  • Recurrence or metastasis
  • Severe cardiopulmonary or musculoskeletal disease
  • Neurological or cognitive limitations
  • Ongoing oncological treatment

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-кроссовер

Центры проведения

Испания · 1 центр
  • Facultad de Mecina y Ciencias de la Salud — Badajoz

Идентификаторы

NCT: NCT06976593 · 050525

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗