NCT02804308已完成不适用
Effectiveness of Physical Training on Body Composition, Physical Activity Level and Quality of Life of Postmenopausal Women Undergoing Treatment for Breast Cancer With Aromatase Inhibitors: The Randomized Clinical Trial.
Universidade Estadual Paulista Júlio de Mesquita Filho0 个研究点目标入组 83 人开始时间: 2015年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 主要终点
- Chance from Body composition at 9 months assessment by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT
研究概览
简要总结
Breast cancer is a multifactorial disease affecting women, and one of the treatments for its healing and survival is hormone therapy. Aromatase inhibitors are third-generation drugs that promote lower chance of metastasis, but their side effects include the loss of bone mineral density and increased fat percentage. In this way, the Combined Training (combined resistance and endurance training) may be an interesting strategy to minimize the side effects of aromatase inhibitors, providing better quality of life, survival and changes in body composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal, defined by the absence of periods for the past 12 months;
- •Breast cancer diagnosis stages 1 to 3;
- •The adjuvant treatment for breast cancer and / or neoadjuvant aromatase inhibitors
- •No abnormalities on screening physical or any health problems that contraindicate study participation;
- •No contraindications for treadmill testing or entry into a training program, including any of the following:
- •Myocardial infarction within the past 6 months
- •Pulmonary edema
- •Myocarditis Pericarditis
- •Unstable angina
- •Pulmonary embolism or deep vein thrombosis
- •Uncontrolled hypertension (i.e., blood pressure > 200/100 mm Hg)
- •Uncontrolled arrhythmia
- •No significant mental illness
- •Have medical certificate to perform exercise testing and participate in combined training
- •Able to answer Questionnaires
- •No concurrent participation in any other organized exercise program;
- •Live in Presidente Prudente
- •Sign the consent form and formal clarification for participation in the study.
排除标准
- •Accumulating 3 unexcused absences or 4 consecutive unexcused absences during the month.
结局指标
主要结局
Chance from Body composition at 9 months assessment by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT
时间窗: At baseline, 3, 6 and 9 months timepoint
次要结局
- Serum levels of C-reactive protein (CRP) in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5(At baseline, 3, 6 and 9 months timepoint)
- VO2max by test of submaximal effort(At baseline, 3, 6 and 9 months timepoint)
- Responsiveness on body composition by bone densitometry (Dual-energy x-ray absorptiometry).(At baseline, 3 and 6 months timepoint)
- Use time of aromatase inhibitor and the response to combined training in the variables of body composition and level of physical activity by bone densitometry (GE Lunar - DPX-NT) and accelerometer motion sensor type triaxial Actigraph brand, mode GT3X(At baseline, 3 and 6 months timepoint)
- Self reported Drug consumption questionnaire(At baseline, 3, 6 and 9 months timepoint)
- Serum levels of glucose in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5(At baseline, 3, 6 and 9 months timepoint)
- Serum of osteocalcin and the carboxyterminal telopeptides of collagen type I (CTX) measured at Serum CrossLaps Assay(At baseline, 3, 6 and 9 months timepoint)
- Serum levels of total cholesterol and fractions in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5.(At baseline, 3, 6 and 9 months timepoint)
- Physical Activity of accelerometer motion sensor type triaxial Actigraph brand, mode GT3X.(At baseline, 3, 6 and 9 months timepoint)
- Responsiveness on habitual physical activity by accelerometer motion sensor type triaxial Actigraph brand, mode GT3X (Actigraph LLC, Pensacola, FL).(At baseline, 3 and 6 months timepoint)
- Bone mineral density (total, spine and femur) in these participants by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT.(At baseline, 3, 6 and 9 months timepoint)
- Serum levels of triacylglycerol in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5(At baseline, 3, 6 and 9 months timepoint)
- The perception of pain is measured by Pain Brief Questionnaire (PBQ(At baseline, 3, 6 and 9 months timepoint)
- Quality of life assessed via the questionnaire EORTC (European Organization for Research and Treatment of Cancer Quality of Life Questionnarie).(At baseline, 3, 6 and 9 months timepoint)
研究者
Thais Reis Silva de Paulo
masters degree
Universidade Estadual Paulista Júlio de Mesquita Filho
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