Comparison of the Effects of Prolonged Resistance-type Exercise Training Between Healthy Postmenopausal Women Versus Postmenopausal Women Survivors of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The changes in skeletal muscle thickness, including measurements for the biceps, triceps brachii, rectus femoris, vastus intermedius, and the total quadriceps, will be assessed using muscular ultrasound after prolonged resistance-type exercise training
研究概览
简要总结
Background: In postmenopausal women, an alteration in body composition occurs as a consequence of the secretion of low levels of serum estrogens by the ovaries. Observing an increase in abdominal and mammary fat mass and a decrease in skeletal muscle mass, which is also accompanied by loss of muscle strength and physical function, which leads early to a sarcopenia.
On the other hand, the increase in estrogen production by adipose tissue has been associated with an increased risk of breast cancer during menopause because the mammary parenchyma is particularly sensitive to this type of estrogen. For this reason, Hormone Therapy (Aromatase Inhibitors and Tamoxifen) is prescribed in women with estrogen receptor-positive breast cancer. Antineoplastic treatments (Chemotherapy and Hormonal Therapy) have contributed to non-metastatic breast cancer currently presenting a high survival rate, not without adverse effects associated with the course of the disease, age and antineoplastic treatment, affecting various systems, but particularly skeletal muscle mass.
Therefore, resistance exercise training has been proposed as an effective intervention strategy to increase muscle mass and strength in different populations. However, the level of muscle response to this type of training in postmenopausal women survivors of breast cancer with and without hormone treatment (Aromatase Inhibitors and Tamoxifen) is unknown.
详细描述
Hypothesis: The increase in skeletal muscle mass after 12 weeks of progressive resistance-type exercise training is less in postmenopausal breast cancer survivors compared to healthy women of the same age range.
Postmenopausal breast cancer survivors without hormonal therapy will have greater gains in skeletal muscle mass compared to breast cancer survivors with Hormone Therapy (Aromatase Inhibitors or Tamoxifen) of the same age range after 12 weeks of progressive resistance-type exercise training.
Goals: The primary aim of this study is to compare the effects of a 12-week progressive resistance-type exercise training on muscle mass (whole body muscle mass) in healthy postmenopausal women versus postmenopausal women survivors of breast cancer with and without Hormone Therapy (Aromatase Inhibitors and Tamoxifen).
Specific goals Determine whether resistance-type exercise training can increase muscle strength and quality of life in healthy postmenopausal women versus postmenopausal women survivors of breast cancer with and without Hormone Therapy (Aromatase Inhibitors and Tamoxifen).
Identify whether circulating biochemical markers are up- or down-regulated in in healthy postmenopausal women versus postmenopausal women survivors of breast cancer with and without Hormone Therapy (Aromatase Inhibitors and Tamoxifen) after resistance-type exercise training
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy postmenopausal women and postmenopausal women survivors of breast cancer with and without Hormonal Therapy (Aromatase Inhibitors and Tamoxifen) between 45 to 59 years.
- •Women survivors of breast cancer with active Hormone Therapy in the last 12 months.
- •Women breast cancer survivors with luminal molecular profile and positive estrogen receptors.
- •Body mass index 18.5 < BMI < 30 kg/m
- •Volunteers without cognitive impairment (abbreviated Minimental >13 points).
排除标准
- •Active antineoplastic treatment in the last 12 months.
- •>200 mL of volume difference between upper limbs and/or stage IV breast cancer.
- •Performing regular resistance training (2 or more times per week, carrying out progressive training) in the previous 6 months.
- •Cardiovascular diseases that are contradictory for physical activity (not included controlled Hypertension).
- •All co-morbidities interacting with mobility and muscle metabolism of the body and that do not allow to (safely) perform the resistance-type exercise training (e.g. debilitating arthritis, spasticity/rigidity, all neurological disorders and paralysis).
结局指标
主要结局
The changes in skeletal muscle thickness, including measurements for the biceps, triceps brachii, rectus femoris, vastus intermedius, and the total quadriceps, will be assessed using muscular ultrasound after prolonged resistance-type exercise training
时间窗: Before, and after 12 weeks of training
Measurements will be in centimeters.
次要结局
- Change in milligrams per deciliter (mg/dL) of glucose via methods enzymatic-colorimetric(Before, and after 12 weeks of training)
- Change in kilograms of the legs strength measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training(Before, and after 12 weeks of training)
- Change in points of the physical performance measured via Short physical performance battery (SPPB) after prolonged resistance-type exercise training(Before, and after 12 weeks of training)
- Change in kilograms of the hand grip strength measured via JAMAR handheld dynamometer after prolonged resistance-type exercise training(Before, and after 12 weeks of training)
- Change in points quality of life measured via questionnaire European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) after prolonged resistance-type exercise training(Before, and after 12 weeks of training)
- Change in kilograms of the arms strength measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training(Before, and after 12 weeks of training)
- Change in milligrams per deciliter (mg/dL) of lipid profile via methods enzymatic-colorimetric(Before, and after 12 weeks of training)
- Change in microgram per milliliter (µg/ml) of Human Insulin via ELISA after prolonged resistance-type exercise training(Before, and after 12 weeks of training)
研究者
Gabriel Nasri Marzuca-Nassr
Professor
Universidad de La Frontera