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临床试验/NCT05241925
NCT05241925尚未招募不适用

Effects of Continuous and Interval Physical Training Through the Intensity of the Incremental Shuttle Walk Test, on Functional Capacity and Quality of Life in Women With Malignant Breast Cancer During Chemotherapy Treatment

University of Nove de Julho0 个研究点目标入组 60 人开始时间: 2023年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Maximum endurance test (1RM)

研究概览

简要总结

Cancer on the world stage remains a major public health problem and the most common type among women.

Female breast cancer survivors often have multiple comorbidities such as diabetic, heart disease, sarcopenia, arthritis, hypertension, and others. In addition to fatigue, reduced functional capacity of the affected upper limb and decreased quality of life. The effects of antineoplastic treatment associated with chronic diseases predispose the emergence of cardiotoxicity, increasing the risk of developing cardiovascular diseases (CVD) and may lead to a decline in quality of life. This situation is due to the adverse effects that antineoplastic therapy exerts on the cardiovascular system.

According to the American Heart Association and American Cancer Society, physical exercise is one of the strategies adopted to prevent and reduce the effects of anticancer therapy, promoting effects on cardiovascular reserve5,6. Currently, although physical activity is essential for cancer survivors, the most effective exercise strategies (intensity, duration and type of exercise) to improve complications from breast cancer have not yet been defined.

The aim of the study is to investigate the effects of different types of physical training associated with functional capacity and quality of life in women undergoing antineoplastic treatment for breast cancer.

详细描述

Cancer is a universal term used for a large group of diseases, characterized by the disordered growth of cells beyond their usual limits, which can affect adjacent parts of the body and/or spread to other organs and tissues. Breast cancer worldwide is a major public health problem, being among all types of neoplasm the most common among women, regardless of age and ethnicity.

Treatment for breast cancer may include surgery, radiation therapy, and systemic therapies such as chemotherapy, hormone therapy, or biological therapy. A number of factors are considered to determine the treatment and sequence of therapies. With advances in early detection and treatment of cancer, the survival rate has increased in more developed countries, reaching 85% in the first five years after diagnosis.

The survival of patients with breast cancer has increased, generating greater concern for the individual's overall well-being. Chemotherapy treatments can cause short or long-term cardiorespiratory limitations, reduced functional capacity and worse quality of life, making daily activities difficult for these patients.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of confirmed breast cancer. Duration of adjuvant chemotherapy treatment. Undergoing surgery for breast cancer treatment.

排除标准

  • neoplasm prior to breast cancer
  • heart disease;
  • musculoskeletal disorder;
  • respiratory disease;
  • uncontrolled arterial hypertension - factors that limit the performance of any of the assessments and/or training in the study.
  • Not having undergone chemotherapy or radiotherapy prior to the diagnosis of breast cancer.

结局指标

主要结局

Maximum endurance test (1RM)

时间窗: Maximum endurance test (1RM)

Kg

Distance Incremental Shuttle Walk Test (SWTI)

时间窗: Distance Incremental Shuttle Walk Test (SWTI)

Distance walking meters

次要结局

  • Brief Fatigue Inventory Questionnaire (BFI)(Brief Fatigue Inventory Questionnaire (BFI))
  • Functional Assessment of Breast Cancer Therapy Questionnaire (FACT-B)(Functional Assessment of Breast Cancer Therapy Questionnaire (FACT-B))
  • Time Grocery Shelving Task Test(Time Grocery Shelving Task Test)
  • European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)(European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

LUCIANA MARIA MALOSA SAMPAIO

PhD

University of Nove de Julho

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