Study Results
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Basic Information
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UNKNOWN
NA
248 participants
INTERVENTIONAL
2022-01-01
2023-12-30
Brief Summary
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Detailed Description
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After the diagnosis of the disease and evaluation of its stage, the treatment can be defined as neoadjuvant or adjuvant; systemic or regional locus. Breast cancer treatments cause cardiovascular dysfunctions, which are due to age-related factors, pre-existing chronic diseases, comorbidities such as smoking, dyslipidemia and obesity, in addition to cancer treatment.Therapies for breast cancer have a strong association with impaired cardiac function, from transient and reversible changes to permanent dysfunctions, as well as changes in lipid metabolism.
The cardiotoxic effects of cancer treatments can also affect vagal activity and, thus, influence cardiac autonomic balance. In the long run, autonomic imbalance is associated with an increased risk of cardiovascular disease and mortality, and in addition, the autonomic dysfunction that is common in many types of cancer leads to an increase in sympathetic tone and a decrease in cardiac vagal tone. As a way of assessing autonomic activity and vagal response, measures of heart rate variability (HRV) have been adopted. A reduction in parasympathetic modulation and HRV indices was observed in women with breast cancer who underwent chemotherapy, radiotherapy and hormonal therapy after one year of treatment. Physical training, which already has satisfactory results in cancer patients in relation to quality of life related to health, functionality and other aspects, also showed benefits in the autonomic modulation of patients with breast cancer. In non-cancer patients, exercise interventions show improvements in the modulation of autonomic function, minimizing cardiovascular problems and reducing mortality after episodes of myocardial infarction.
In addition to the cardiotoxic effects, cancer treatment favors the appearance of muscle changes. A systematic review with 754 women with breast cancer showed sarcopenia as a risk factor for mortality in 68% of patients. Not only the pathophysiology of cancer, but also drugs used for its treatment contribute to the loss of muscle mass.
Research indicates that physical exercise can mitigate the declines induced by cancer treatment. There is sufficient evidence to support that exercise improves fitness before, during and after treatment is completed. A cardiovascular rehabilitation program based on education and behavioral counseling offers a modification of cardiac risk, increases functional capacity, ensures monitoring of the patient's functional status, improves psychosocial well-being and can reduce recurrent hospitalizations.
Home rehabilitation can be an alternative for patients with moderate cardiac risk, self-monitoring capacity and with difficulties to attend due to social or displacement reasons. Considering the profile of the user of the Unified Health System, interventions at home and in the community seem to be the best way, together with telephone contacts for questions and / or guidance.
Pre-qualification in cancer treatment is an opportunity to increase physiological reserves even before neoadjuvant therapies or surgery, with the intention of improving results and accelerating recovery. May consist of physical exercises, nutritional and psychosocial interventions.
Knowing the nutritional profile of patients is of great importance considering the negative impact of an impaired nutritional status on postoperative outcomes. Excess weight or depletion has been reported as a factor that negatively influences surgical and cancer outcomes. The identification of patients at nutritional risk and probable sarcopenia will define an early nutritional orientation through an individualized diet with a focus on improving body composition, glycemic control, since preoperative glycemic control is associated with a lower incidence of infectious complications; and management of symptoms related to cancer treatment.
Combined with treatment, behavioral counseling is effective in motivating changes in lifestyle, which are part of the modifiable risk factors for breast cancer. Thinking about the risks that accompany the diagnosis of breast cancer, a rehabilitation focused on treating current disorders and anticipating future complications are the first steps to improve the results of care and reduce costs.
GOALS Main goal To evaluate the effectiveness of physical exercise in a surgical pre-habilitation program for women diagnosed with breast cancer who underwent cancer treatment with a curative therapeutic proposal at the Cancer Hospital III of the National Cancer Institute.
Specific objectives
* Describe the sociodemographic and clinical characteristics of the study population
* Identify the rate of adherence to physical exercise and associated factors;
* To assess changes in functional and cardiopulmonary capacity, fatigue, health-related quality of life, level of physical activity, cardiac autonomic modulation and sarcopenia in women diagnosed with breast cancer, before and after surgical treatment and throughout the follow-up periods. according to the intervention group;
* Assess the nutritional status and body composition in the inclusion of patients in the study and before surgical treatment in all participating women;
* To verify the association between regular physical exercise before surgical treatment and functional and cardiopulmonary capacity, fatigue, level of physical activity, health-related quality of life, cardiac autonomic modulation and sarcopenia in comparison with the control group;
* Describe the perception of patients regarding the performance of pre-habilitation exercises;
* To evaluate the behavioral change in the practice of physical exercises after the surgical treatment of breast cancer.
SAMPLE SIZE For the calculation of the sample size, the incidence of complications (outcomes) was considered to be 10% in the intervention group and 30% in the control group, with an alpha error of 0.05, a beta error of 0.20 and a power of 80%. Based on these parameters, it will be necessary to include 62 patients in each group. However, due to the evaluation of different outcomes and the lack of data on the incidence of complications in this population, all eligible patients will be included in the study inclusion period.
LOSS CONTROL Losses related to change, lack of information and abandonment will represent a small number, as patients remain on cancer treatment for approximately 5 years at the institution. The non-recoverable losses will have data collected from the medical records to be compared with the patients who completed the follow-up.
DATA ANALYSIS The data will be analyzed by intention to treat. The descriptive analysis will be performed by measures of central tendency and dispersion (quantitative variables) and distribution of absolute and relative frequency (qualitative variables).
To assess the normal distribution of outcomes and quantitative control variables, the Kolmogorov-Smirnov test will be performed.
To assess changes between groups in the pre- and / or post-intervention stages, the mean values will be compared by the t-student test or Mann-Whitney U test (non-parametric distribution). When analyzing the pre-verus comparison after intra-group intervention, the paired t-student test will be considered. For all analyzes, p-value less than 0.05 will be considered statistically significant.
To assess the linearity between the outcome and the quantitative adjustment variables, the dispersion diagram will be performed. Quantitative independent variables that do not have a normal distribution will be categorized. To test the collinearity of the categorical independent variables, Pearson's correlation will be performed.
To assess the association between the intervention groups and the quantitative outcomes, the differences between the means will be calculated and tested by analysis of variance, considering a value of p \<0.20. Multiple linear regression will be performed using the enter method (stepwise forward), considering the 95% confidence interval. Homoscedasticity and possible biases of the model will be analyzed through residual analysis and all assumptions will be observed. To identify the explanatory power of the model, the determination coefficient will be performed. The association between intervention groups and categorical outcomes will be performed by univariate analysis, using the odds ratio (OR), assuming 95% confidence intervals (95% CI). Associations with clinical and statistical significance in the univariate analysis (considering p \<0, ETHICAL AND LEGAL ASPECTS This study was submitted to the Research Ethics Committee of the National Cancer Institute (CEP / INCA), under CAAE 42627521.6.0000.5274, and approved as per opinion 4.576.731. At the time of recruitment, women will be instructed on the objectives of the study and those who agree to participate will sign the Free and Informed Consent Form (ICF).
RISK AND BENEFITS Performing physical assessments will not pose any health risks to patients. The practice of unsupervised physical exercises is safe for people without any chronic health impairment, as already mentioned in the exclusion criteria. To reduce the risks, patients will be instructed on the level of effort during the practice and on signs and symptoms of decompensation, being instructed to contact the researcher, if necessary.Despite the small risk, palpitation, excessive sweating, dizziness and shortness of breath may occur when exercising at home. If this occurs, patients will be instructed to end the exercise and contact the research team.. The study population will benefit indirectly through the results, which will analyze the effectiveness of the pre-habilitation program in improving functional capacity, fatigue, health-related quality of life, level of physical activity and autonomic modulation of women undergoing treatment for breast cancer, making it possible to plan actions to control complications.The intervention group, which will perform home physical exercises according to the guidelines, will benefit from the effects of physical exercise on physical and emotional well-being. When adhering to a healthy habit, physical conditioning, mental health and health-related quality of life improve.
FINANCING This research will not impose any burden on the institution, since patients will be evaluated on the day they attend their routine consultations and other information will be collected from the physical and / or electronic medical record. The rest of the materials will be paid for by the researchers responsible.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Pre-habilitation group + neoadjuvant treatment
The patients in the Pre-habilitation group + neoadjuvant treatment (Group A), will undergo neoadjuvant cancer therapy and be instructed to practice physical exercises at home 03 times a week, during neoadjuvant therapy, until the date of surgery. The pre-habilitation program (intervention) will consist of prescription of physical exercises and guidance on its importance, through a booklet and practice practice diary. The intervention group will be accompanied weekly by a call to encourage the performance of the exercises, and in case of doubts, new explanations regarding the performance of these exercises.
Physical exercise
The prescription will be divided into 3 phases:
Warm-up: with the object of removing the body from rest and preparing it to start the activity, it consists of exercises for upper and lower limbs, 1 minute each.
Physical exercise: Object of physical conditioning, it consists or aerobic training with walking and muscle activation through concentric contraction of the rectus abdominis in supine position, sit and get up from a chair and resistance exercises for upper members. The patient must perform 2 sets of 12 repetitions for each exercise with a 1-minute interval between the sessions.
Stretching and relaxing: Streching the arms above the head, stretching the legs and stretching the trunk to the left and right side will be oriented. Each stretching exercise should be done for 20 seconds. The relaxation should be performed in a sitting position, eyes closed, calm and silent place, soft breathing, for 5 minutes.
Prehabilitation Program + immediate surgical treatment
The patients in the Pre-habilitation group + immediate surgical treatment (Group B), will be instructed to practice physical exercises at home 03 times a week until the date of surgery. The pre-habilitation program (intervention) will consist of prescription of physical exercises and guidance on its importance, through a booklet and practice practice diary. The intervention group will be accompanied weekly by a call to encourage the performance of the exercises, and in case of doubts, new explanations regarding the performance of these exercises.
Physical exercise
The prescription will be divided into 3 phases:
Warm-up: with the object of removing the body from rest and preparing it to start the activity, it consists of exercises for upper and lower limbs, 1 minute each.
Physical exercise: Object of physical conditioning, it consists or aerobic training with walking and muscle activation through concentric contraction of the rectus abdominis in supine position, sit and get up from a chair and resistance exercises for upper members. The patient must perform 2 sets of 12 repetitions for each exercise with a 1-minute interval between the sessions.
Stretching and relaxing: Streching the arms above the head, stretching the legs and stretching the trunk to the left and right side will be oriented. Each stretching exercise should be done for 20 seconds. The relaxation should be performed in a sitting position, eyes closed, calm and silent place, soft breathing, for 5 minutes.
Usual activities + neoadjuvant treatment
Patients allocated to this group (Group C) will not participate in the pre-habilitation program and will be instructed to continue their usual activities during the neoadjuvant cancer therapy, until the date of surgery.
No interventions assigned to this group
Usual activities + immediate surgical treatment
Patients allocated to this group (Group D) will not participate in the pre-habilitation program and will be instructed to continue their usual activities until the date of surgery.
No interventions assigned to this group
Interventions
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Physical exercise
The prescription will be divided into 3 phases:
Warm-up: with the object of removing the body from rest and preparing it to start the activity, it consists of exercises for upper and lower limbs, 1 minute each.
Physical exercise: Object of physical conditioning, it consists or aerobic training with walking and muscle activation through concentric contraction of the rectus abdominis in supine position, sit and get up from a chair and resistance exercises for upper members. The patient must perform 2 sets of 12 repetitions for each exercise with a 1-minute interval between the sessions.
Stretching and relaxing: Streching the arms above the head, stretching the legs and stretching the trunk to the left and right side will be oriented. Each stretching exercise should be done for 20 seconds. The relaxation should be performed in a sitting position, eyes closed, calm and silent place, soft breathing, for 5 minutes.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* staging IV
* practitioner of physical exercise at least 90 minutes per week
* not being able to answer the questionnaires
* be unable to practice unsupervised exercises for any reason, including: dysfunctionss orthopedic, neurological, decompensated cardiorespiratory and severe renal.
18 Years
80 Years
FEMALE
No
Sponsors
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Instituto Nacional de Cancer, Brazil
OTHER_GOV
Responsible Party
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Principal Investigators
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Simone A Saraiva
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Cancer, Brazil
Locations
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Instituto Nacional do Câncer / HCIII
Rio de Janeiro, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Rejane Medeiro Costa
Role: backup
Other Identifiers
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CAAE 42627521600005274
Identifier Type: -
Identifier Source: org_study_id
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