Pilates and Dance to Breast Cancer Patients Undergoing Treatment: MoveMama Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Perception of Quality of life
研究概览
简要总结
Breast cancer is one of the most common types of cancer in Brazil, and its treatment, namely surgery, chemotherapy, radiotherapy or hormone therapy, has consequences and side effects that significantly affect the quality of life and associated physical and psychological factors. The practice of physical activity, in turn, may play a beneficial role in these factors, and help the recovery of the patient in relation to the consequences of the treatments. Two types of physical activity can be addressed in the context of breast cancer; Dance and the Pilates method. Thus, the objective of the present study will be to analyze the impact of Pilates practice and dance on quality of life and on psychological and physical factors in patients undergoing adjuvant treatment of breast cancer. Patients older than 18 years who are in adjuvant treatment, namely, chemotherapy, radiotherapy and / or hormone therapy at the Oncology Research Center - CEPON, will be invited to be part of the study. With a randomized clinical trial of three arms, the patients will be submitted to 16 weeks of intervention, and randomized in 3 groups: (A) belly dance protocol group; (B) Pilates method protocol group, and (C) control group who will continue with their routine activities. Sample randomization will be conducted in confidence by one of the researchers in a specific computer program. Information about personal and clinical characteristics, quality of life, psychological factors (depressive symptoms, body image, self-esteem, optimism, perceived stress, fatigue, pain, sexual function and sleep quality) and physical factors (cardiorespiratory fitness, balance , Posture, upper limb functionality and presence of lymphedema). All information will be collected before and after the intervention period. Statistical analysis will use the statistical package SPSS - IBM, version 20.0. Firstly, descriptive statistics (mean, standard deviation and percentage) will be used in order to know the data, and then the Anova two way test with repeated measurements and Sydak Comparison Test, in order to analyze the data. Groups of the Pilates method, of the dance and control group. Significance level of 5%.
详细描述
The MoveMama Project includes two protocols: (1) Dance and (2) Pilates. Each session for each modality will last 60 minutes, three times a week, for 16 weeks.
In both groups, a chart of patient evolution will be developed during the protocol, which should be updated every week by the researchers responsible for the intervention. In order to control the intensity and safety of the practice of physical activity, since they are about patients who are in period of clinical adjuvant treatment. In this way, the blood pressure (BP), through a sphygmomanometer, and the investigation of the heart rate (HR) will be performed in every first class of the week at the beginning and end of the session.
The Subjective Effort Perception Scale - Borg Scale 6-20 points (BORG, 2000) will also be used to evaluate the intensity and / or discomfort during physical activity practice in both protocols. This 6 to 20-point scale can be used efficiently because of its relationship to heart rate. It should be applied to describe resting sensations to situations of maximum physical effort, considering number six equivalent to 60 bpm (beats per minute), as well as number 20 to 200 bpm (Table 2) (FOSS et al., 2000).
In both modalities of intervention, the evolution of the movements of upper limbs will always be respecting the limit of each patient.
The dance protocol (1) will be performed through the belly dance method. This type of methodology was selected, because it is a practice that involves an intimate relationship between movement and emotion, awakens a spontaneous body language that privileges movements that respect the individuality of each practitioner, for the recovery of the feminine identity, and for be a practice that proposes intense movements of the upper limbs, benefiting patients directly.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage I to III of breast cancer;
- •Be in adjuvant treatment with chemotherapy, radiation therapy or hormone therapy;
- •Receive the release of the oncologist responsible for the practice of physical activity, as well as the Physical Therapy Sector of CEPON.
排除标准
- •Present some orthopedic or neurological limitation that not allows the practice of physical activity.
结局指标
主要结局
Perception of Quality of life
时间窗: 10 minutes
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30 and BR23). Scores range from zero to 100, and the higher the score, the better the quality of life on functional and general health scales, and the smaller the score, worse is the quality of life on the symptomatic scale.
次要结局
- Upper limb function(15 minutes)
- Stress(5 minutes)
- Sexual function(10 minutes)
- Cardiorespiratory fitness(10 minutes)
- Physical Activity(10 minutes)
- Range of motion(15 minutes)
- Depressive Symptoms(10 minutes)
- Sleep Quality(10 minutes)
- Balance(15 minutes)
- Lymphedema(15 minutes)
- Cardiorrespiratory fitness(30 minutes)
- Self-Esteem(5 minutes)
- Optimism(5 minutes)
- Muscular Strength(15 minutes)
- Posture(10 minutes)
- Body image(10 minutes)
- Fatigue(5 minutes)
- Pain level(3 minutes)
- Flexibility(10 minutes)