EXERT-BCH Exercise Regimen to Improve Muscle Mass After Treatment of Breast Cancer

Официальное название

EXERT-BCH: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer to Improve Hypertrophy

Обзор

The purpose of this research study is to evaluate the outcomes of two standard of care group exercise regimens to increase muscle mass in women who have been treated with breast cancer.

Подробное описание

This protocol seeks to analyze patient outcomes of two standard of care, time-efficient, monitored group exercise regimens of high-load resistance training to improve hypertrophy in women who have been treated for ductal carcinoma in situ or invasive carcinoma of the breast.

As part of the standard exercise program, patients will undergo a fitness evaluation at the AHNCI Exercise Oncology and Resiliency Center before the start of the exercise program. This evaluation will be used to customize the patient exercise program. The exercise program consists of small group training sessions held approximately 3 times per week at the center for 12 weeks (3 months). The fitness evaluation and exercise program are standard of care. Participation in this study will last the duration of the exercise program, about 3 months. All group exercise sessions will be closely monitored by the center staff who are Certified Strength and Conditioning Specialists (CSCS).

Вмешательства

• Другое Control Arm ACSM Guidelines
  The control group will follow resistance training guidelines from the American College of Sports Medicine. Eight to ten multi-joint exercises will be performed to stress the major muscle groups.
• Другое Experimental Arm 6-12-25 repetitions per set
  The exercise regimens will employ a mixture of compound exercises utilizing both open and closed kinetic chain movements (CKC), focusing on exercises with the goal of increasing skeletal muscle mass and body composition. The regimen will incorporate 6, then 12, then 25 repetitions in sequence per set per muscle group with minimal amounts of rest between.

Первичные конечные точки

• Determine changes in muscle and fat mass during and after each exercise regimen [Срок оценки: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.]

Вторичные конечные точки (2)

• Determine adherence defined as number of sessions attended of total sessions [Срок оценки: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.]
• Determine changes in strength measured via load calculations (repetitions x sets x weight) [Срок оценки: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.]

Критерии участия

Критерии включения

Age 20-89 years

• Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
• Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.

Критерии исключения

• Any current treatment with cytotoxic chemotherapy for breast cancer
• Inability to safely engage in group sessions of resistance training as deemed by study PI
• Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training

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

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Allegheny General Hospital — Pittsburgh

Идентификаторы

NCT: NCT06115486 · EXERT-BCH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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