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Идёт набор NCT05913713

HIIT Following Breast Cancer Chemotherapy

Без фазы С лечением Breast Cancer

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: 12-week Intervention Period, 12-week Observation Period.
Кому может быть актуально
Состояния в реестре: Breast Cancer. Базовые параметры: 18 лет — 85 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
США
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

High Intensity Interval Training: Optimizing Exercise Therapy to Mitigate Cardiovascular Disease Risk Following Breast Cancer Chemotherapy

Обзор

Chemotherapy is an effective breast cancer treatment, which helped to increase the 5-year survival rate to approximately 95%. However, breast cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect and durability of a novel high-intensity interval training compared to moderate-intensity continuous training on cardiovascular rehabilitation in breast cancer survivors.

Вмешательства

  • Поведенческое 12-week Intervention Period
    Research participants will be randomly assigned to either high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or the usual care (UC) group for a 12-week intervention period.
  • Поведенческое 12-week Observation Period
    After a 12-week intervention period (HIIT, MICT, or UC), research participants will have a 12-week observation period to assess the durability of two types of different exercises.

Первичные конечные точки

  • Change in brachial FMD [Срок оценки: Baseline, Following a 12-week intervention period, Following a 12-week observation period]
  • Change in cardiac function (global longitudinal strain) [Срок оценки: Baseline, Following a 12-week intervention period, Following a 12-week observation period]
  • Percent completed vs. planned exercise frequency [Срок оценки: Throughout the 12 weeks of supervised home-based exercise training]
  • Percent completed vs. planned exercise duration [Срок оценки: Throughout the 12 weeks of supervised home-based exercise training]
  • Percent completed vs. planned exercise intensity [Срок оценки: Throughout the 12 weeks of supervised home-based exercise training]
  • Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention [Срок оценки: Throughout the 12 weeks of supervised home-based exercise training]

Критерии участия

Критерии включения

  • female patients based on biological sex
  • 18 to 85 years of age
  • diagnosis of primary, invasive, non-metastatic, stages I-III breast cancer
  • completed chemotherapy for breast cancer (anthracycline, alkylating agent and/or taxane) more than 6 months but less than 18 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy, and bisphosphonates are allowed within 6 months of study enrollment and during study participation
  • absence of contraindications to exercise or to participate in study
  • study clinician approval

Критерии исключения

  • do not meet inclusion criteria
  • scheduled to receive surgery or radiation therapy during the intervention period
  • any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
  • lymphedema stage ≥2 prior to study enrollment
  • are pregnant
  • current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)

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
Профилактика

Центры проведения

США · 1 центр
  • Integrative Cardiovascular Physiology Laboratory, University of Florida — Gainesville

Идентификаторы

NCT: NCT05913713 · IRB202300460 -N · 1R21AG078995-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗