"Effect of Supervised Resistance Training on Arm Volume and Quality of Life amONG Women at High Risk for Breast Cancer-related Lymphedema: a Study Protocol for a Randomized Controlled Trial (STRONG-B)"
试验速览
- 阶段
- 不适用
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Change from Baseline in Arms lymphedema Volume on the Perometer System at 3, 6 and 9 months.
研究概览
简要总结
Breast cancer (BC) is the most common neoplasm in Chile, and its medical treatment leads to high survival. One-third of survivors will develop BC-related lymphedema. Lymphedema is a chronic condition characterized by increased volume in the ipsilateral arm to surgery. A higher volume is associated with decreased physical functionality and quality of life. Recent studies suggest that resistance training could control arm volume through increased muscle mass development, improving physical functionality and quality of life for patients. To our knowledge, there is no study that has analyzed the effect of a resistance training program among women at risk of BC-related lymphedema on arm volume and quality of life. The purpose of this study is to determine the effect of resistance training on the arm volume and quality of life among women with adjuvant chemotherapy and high risk of BC-related lymphedema compared to a control group with regular physical therapy management, which does not include resistance training.
This is a randomized controlled study. It will be held at the Complejo Asistencial Dr. Sotero del Río, which receives all patients from the South East Metropolitan Health Service. Participants: 106 women receiving adjuvant chemotherapy for BC who have undergone axillary lymph node dissection or with obesity will be recruited. The difference in volume between the arms will be evaluated with optoelectric equipment. Quality of life with The European Organization for Research and Treatment in Cancer Quality of Life C-30 (EORTC QLQ-C30) and the European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire BR23 (EORTC QLQ-BR23) questionnaires, both validated in Chile; the handgrip with a dynamometer; and physical functionality with the six-minute walk test. Volunteers will be randomly assigned to the resistance training group or control group. The resistance training group will consist of twice a week supervised sessions, for 12 weeks. The exercises will be for arms and legs, self-loading type, and with external weights. The control group will follow the usual physical therapy management, which does not include resistance training. Subsequently, volunteers will be evaluated at the third and sixth months after completion of the 12 weeks resistance training program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with stage I-III breast cancer, histologically confirmed.
- •Patients scheduled to receive adjuvant post-operative chemotherapy.
- •Partial or total mastectomy with axillary node dissection.
- •Partial or total mastectomy with sentinel node dissection with body mass index between 30.0 and 39.9 kg/m
- •Approval of their treating physician to participate in sub-maximal physiological fitness testing and a low to moderate progressive resistance exercise program.
排除标准
- •Inter-limb volume difference greater than 200 ml or 10%.
- •Previous antineoplastic treatment (chemotherapy, radiotherapy, or endocrine therapy).
- •Breast cancer stage IV
- •Unable to participate in an exercise program related to other medical problems.
- •Be identified as vigorous exercise behavior related to American College of Sports Medicine recommendations.
- •Body mass index lower than 18.5 kg/m2 or greater than 40 kg/m
- •Pregnancy.
- •Fluency and understanding of the Spanish language.
结局指标
主要结局
Change from Baseline in Arms lymphedema Volume on the Perometer System at 3, 6 and 9 months.
时间窗: Baseline, 3, 6 and 9 months.
Perometer is considered the gold standard for determining lymphedema volume in research. Is a valid and reliable tool in volume measurement. It determines volume values expressed in milliliters and percentage. A value of 200 mL or 10% difference between one arm and the other is considered significant.
Change from Baseline in Health-related quality of life on questionnaire: The European Organization for Research and Treatment in Cancer (EORTC) Quality of Life C-30 (QLQ-C30) and breast cancer-specific module QLQ-BR23 at 3, 6, and 9 months.
时间窗: Baseline, 3, 6 and 9 months.
The QLQ C-30 and specific module QLQ-BR23 are self-administered and validated questionnaires to assess health-related quality of life in patients with breast cancer. Both had been validated in Spanish language and on Chilean population. QLQ-C30 comprises 30 items to assess physical, role, emotional, cognitive, and social functioning. The QLQ-BR23 is a breast-specific module that comprises 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects. All scores were linearly transformed to a 0 to 100 scale. A high functional score represents a high or healthy level of functioning. A high QOL is defined by a high score for global health status or QOL. High symptom scores or items represent more severe symptoms or problems.
次要结局
- Change from Baseline in Hand grip strength on Hydraulic Hand Dynamometer at 3, 6 and 9 months.(Baseline, 3, 6, and 9 months.)
- Change from Baseline in Physical Fitness Six minute walk test at 3, 6 and 9 months.(Baseline and 3, 6 and 9 months.)