An interventional study of Health Education and Physical Exercise in Cancer, Breast, sponsored by Hospital Israelita Albert Einstein. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-09-18.
Sponsored by Hospital Israelita Albert Einstein · Not applicable, Interventional, and Supportive care
The purpose of this study is to verify the effect of the intervention of a program of physical exercises and health education in women with breast cancer undergoing chemotherapy.
According to the National Cancer Institute (INCA), the estimate for Brazil, 2016-2017 biennium, points to the occurrence of about 600,000 new cases of cancer, and breast cancer (58000) in women will be the most frequent. One study revealed that only 12% of women undergoing chemotherapy in CM who participated in a physical exercise program had to readjusted the dose of the medications, while 34% of those who received the conventional treatment needed to readjust the Treatment doses, with neuropathy being one of the most present adverse effects that influenced this adjustment. In this sense, the conduct to keep the patient at rest during the treatment seems to potentiate her side effects, and sedentarism is another factor detrimental to the patient's health. Objective: To verify the effect of the intervention of a program of physical exercises and health education in women with breast cancer undergoing chemotherapy. Methodology: A sample will consist of 136 (136) Women, over 18 years of age, sedentary, diagnosed with non-metastatic breast cancer and initiating the first cycle of chemotherapy. They will be divided into two groups, randomly and stratified: control group: (CG n = 68) and exercise group: (eg n = 68) that will undergo a supervised training program of combined exercises for 24 weeks, with a frequency of 3 times Weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week and both groups (GC and EG) will attend lectures on health education, which are held monthly.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 136 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hospital Israelita Albert Einstein is the lead sponsor of 143 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Will attend lectures on health education.
Behavioral: Health Education · Behavioral: Physical Exercise
Will be subjected to a supervised training program of combined exercises for 24 weeks, with a frequency of 3 times weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week and Will attend lectures on health education.
Behavioral: Health Education · Behavioral: Physical Exercise
Will attend lectures on health education about Health and Physical Education, healthy eating, overcoming barriers, Back to routine, Physical Activity Options and Dealing with Stress and Depression
Supervised physical training program of combined exercises for 24 weeks, with frequency of 3 times weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week.
Chemotherapy completion rate
Effect of physical training on the rate of chemotherapy completion in the anthropometric profile, habitual food consumption, prevalence of comorbidities, cardiovascular, neurofunctional, bone and respiratory toxicity, myelosuppression, sarcopenia induced by chemotherapy, myalgia, nausea and vomiting symptoms.
Time frame: 6 months
Analysis of the level of Quality of Life
effect of physical training on the level of physical activity, perception of fatigue and pain, mood, sexual life, anxiety and depression and body image.
Time frame: 6 months
Physical aptitude
Effect of physical training during adjuvant and neoadjuvant chemotherapy on the levels of fragility, muscle strength, joint amplitude of the shoulder and cardiorespiratory capacity.
Time frame: 6 months
Plan to share: No
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This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Hospital Israelita Albert Einstein