Оценка влияния программы аэробных упражнений на сосудистую функцию у женщин с неметастатическим раком молочной железы
The goal of this clinical trial is to assess the feasibility of an 8-week aerobic exercise program and its effect on arterial function in breast cancer survivors.
The main questions it aims to answer are:
- Is an 8-week aerobic exercise program feasible in breast cancer survivors after the completion of chemotherapy, immunotherapy and/or anti-HER2 agents?
- Is this 8-week aerobic exercise program beneficial for vascular function in breast cancer survivors?
Participants will:
- Begin an 8-week aerobic exercise program, three days per week, after the completion of chemotherapy, immunotherapy and/or anti-HER2 agents.
- Visit our facility three times: before the exercise program, 1 month after, and after the completion of the program.
- Complete questionnaires, physical functional tests, and body composition and vascular measurements at every visit.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Georgios Grigoriadis, PhD
- Номер телефона: 773-508-3658
- Электронная почта: ggrigoriadis@luc.edu
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion criteria:
- Women (18-70 years) with a stage I-III breast cancer diagnosis who have completed chemotherapy, immunotherapy and/or anti-HER2 agents.
- Able to begin aerobic exercise within 12 weeks of the final chemotherapy, immunotherapy and/or anti-HER2 agents.
- Sedentary by self-reporting inactivity (<90 min of moderate or vigorous exercise per week)
- Weight ≤154 kg
- Willing to complete all study activities
- Able to safely participate in moderate aerobic exercise.
Exclusion criteria:
- Current pregnant and lactating patients. Must have completed lactation prior to study start.
- Metastatic disease.
- Diagnosed cardiovascular disease prior to the initiation of cancer therapy, as evidenced by cardiomyopathy (reduced regional or global left ventricular contractility), diastolic dysfunction grade 2 or above, symptomatic coronary artery disease, ejection fraction below 50%.
- Non-English speaking
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Упражнения вмешательства
|
Participants will perform aerobic exercise three times per week for 8 weeks, with each session consisting of 30 minutes at 40-59% of heart rate reserve (HRR). Each session will also include a 10-minute warm-up and a 5-minute cool-down. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Enrollment (Recruitment rate)
Временное ограничение: From enrollment to immediately after first visit
|
Enrollment will be measured by the proportion of eligible breast cancer survivors who provide informed consent to participate in the study. The proportion of enrolled participants will be reported. |
From enrollment to immediately after first visit
|
|
Participant adherence - Proportion of people considered adherent
Временное ограничение: From enrollment to the end of intervention at 8 weeks
|
Adherence will be measured as the proportion of exercise sessions completed by consented survivors out of the total of 24 prescribed training sessions. Completion of at least 18 of the 24 training sessions will be considered adherent. |
From enrollment to the end of intervention at 8 weeks
|
|
Retention - Proportion of survivors who completed the study
Временное ограничение: From enrollment to the end of intervention at 8 weeks
|
Retention will be measured by the percentage of consented survivors that completed the research study compared to the total number initially enrolled. The proportion of survivors who completed the study will be reported. |
From enrollment to the end of intervention at 8 weeks
|
|
Pulse Wave Velocity
Временное ограничение: From enrollment to the end of intervention at 8 weeks"
|
This test measures how stiff your arteries are (called pulse wave velocity). Pulse wave velocity is an important measure that can help predict the risk of heart and blood vessel disease. It is a simple, non-invasive test, which means it does not involve needles or anything that goes inside your body. We will use a device called the SphygmoCor XCEL to do the test. To measure this, we will place a small sensor on your neck (over the carotid artery) and a blood pressure cuff on your upper thigh (over the femoral artery). The cuff will inflate slightly while we record your pulse waves. We will also use a tape measure to find the distance between the two spots. This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention. |
From enrollment to the end of intervention at 8 weeks"
|
|
Aortic Blood Pressure
Временное ограничение: From enrollment to the end of intervention at 8 weeks
|
We will use a simple, non-invasive test to estimate the aortic blood pressure with a device called the SphygmoCor XCEL. The device measures your blood pressure using a cuff placed on your upper arm. Aortic blood pressure is another test we use to check the health of the heart and blood vessels. This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention. |
From enrollment to the end of intervention at 8 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Blood Pressure
Временное ограничение: From enrollment to the end of intervention at 8 weeks
|
Participants will be asked to wear a blood pressure cuff on their arm with a small monitoring recording pack (ABPMpro device). The device will take measurements every 2 minutes. Participants will undergo two blood pressure measurements. If the two measurements are not within 5 mmHg for both systolic and diastolic blood pressure, additional measurements will be obtained until this criterion is satisfied. The blood pressure device gives a reliable measurement of the blood pressure, which is an important way to check your heart and blood vessel health This measurement will be conducted on three occasions: before the intervention begins (Visit 1), and after the 4th (Visit 2) and 8th (Visit 3) weeks of the intervention. |
From enrollment to the end of intervention at 8 weeks
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 219222
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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