Effects Of Physical Training On Cardiovascular Capacity In Patients Undergoing Chemotherapy For Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: physical training.
- Who it may be relevant to
- Registry conditions: Cardiac Abnormalities, Chemotherapeutic Toxicity. Basic parameters: 18 years — 59 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Introduction: Cancer treatment, especially chemotherapy and radiotherapy, can lead to cardiovascular dysfunctions, such as a decrease in left ventricular ejection fraction and electrical dysfunction of the heart, which may consequently compromise patients' quality of life. In this context, physical exercise is a beneficial and promising tool, as it can prevent and minimize the deleterious effects of oncological therapies and their complications. Objective: To evaluate the effect of physical exercise on the prevention of cardiovascular diseases (CVD) induced by cancer treatment, analyzing the impact of supervised exercise on cardiovascular function and quality of life. Materials and Methods: This is a clinical trial in which the sample will consist of 60 individuals undergoing cancer treatment, who will be stratified and randomized according to cancer stage classification into two groups: Intervention Group (IG) and Control Group (CG). The intervention will last 12 weeks, during which the IG will receive a prescription for physical exercises based on the FITT principle (frequency, intensity, time, and type), three times per week, while the CG will remain under usual care. Data will be presented using descriptive statistics, tests for two independent samples, and multivariate analysis, comparing the intervention effects between the two groups using R software version 4.3.3. Expected Results: Low incidence of CVD, improved heart rate variability, adherence to the exercise protocol, reduced risk for cardiovascular diseases, improvement in fatigue, functional capacity, and quality of life. Data will be collected at baseline, at the 6th week, and at the 12th week of intervention.
Detailed description
Cancer is a disease characterized by the uncontrolled growth of abnormal cells that invade organs and tissues. It is one of the leading causes of mortality worldwide, with high incidence and prevalence. Despite the progress in cancer treatment, it can generate a range of side effects and increase the risk of developing other diseases.
Cardio-oncology has become an area of great importance in research and presents a bidirectional relationship, as it links cardiovascular diseases to the risk of developing cancer and vice versa. It also focuses on the early diagnosis of CVD in patients undergoing cancer treatment. Cardio-oncology investigates and identifies factors that may cause cardiac damage, compromising the heart's structure and function, and relates these factors to the chemotherapy used.
One of the complications of chemotherapy is anthracycline-induced cardiotoxicity, which leads to increased expression of cellular senescence and adverse effects on the heart, including ventricular dysfunction, arrhythmias, myocardial fibrosis, and heart failure. These effects are dose-dependent and may be irreversible.
In this context, it is essential to adopt strategies that mitigate the impact of cardiotoxicity, improving prognosis and the quality of life of patients undergoing cancer treatment. Studies have shown that physical exercise has positive effects on quality of life, autonomic function, cardiopulmonary function, strength, and functional capacity during the phases of anticancer therapy.
Given this scenario, this study is justified by the emerging need for knowledge about the benefits of physical training on cardiovascular capacity, contributing to the elucidation of clinical practice, effective decision-making, and better management of this population.
Interventions
- Other physical training
The concurrent physical training program will last 12 weeks and will consist of aerobic and resistance exercises.The physical exercises for aerobic training will consist of walking and/or cycling on a stationary bike, performed 3 times a week with progressive intensity.Strength training exercises for upper (UL) and lower (LL) limbs will be performed using dumbbells, ankle weights, resistance bands, and body weight for patients undergoing chemotherapy.
Primary outcome measures
- Cardiotoxicity [Time frame: From registration to the end of treatment in 12 weeks]
- Heart rate variability [Time frame: From registration to the end of treatment in 12 weeks]
- Cardiovascular risk in cancer patients. [Time frame: From registration to the end of treatment in 12 weeks]
Secondary outcome measures (6)
- Fatigue [Time frame: From registration to the end of treatment in 12 weeks]
- pain assessment [Time frame: From registration to the end of treatment in 12 weeks]
- Quality of life Global [Time frame: From registration to the end of treatment in 12 weeks]
- Body Composition [Time frame: From registration to the end of treatment in 12 weeks]
- functional capacity [Time frame: From registration to the end of treatment in 12 weeks]
- adherence to physical exercise [Time frame: From registration to the end of treatment in 12 weeks]
Eligibility criteria
- Inclusion Criteria:
- Patients with a confirmed diagnosis of cancer who are undergoing chemotherapy treatment with anthracyclines;
- No physical exercise intervention for the past 3 months;
- Patients in the early or intermediate stages of cancer treatment;
- Adult patients (e.g., 18 to 59 years old) to avoid extreme variations in response to physical exercise;
- Clinically stable patients, without absolute contraindications to physical exercise (e.g., decompensated heart failure, severe arrhythmias);
- Patients able to participate in a supervised physical exercise program during the study period
- Exclusion Criteria:
- Patients with severe pre-existing cardiac conditions (e.g., advanced cardiomyopathy, unstable angina) that prevent safe exercise practice;
- Patients with physical (e.g., inability to walk) or cognitive limitations that prevent participation in the physical exercise program;
- Patients undergoing treatments that may interfere with the results (e.g., recent thoracic radiotherapy, use of cardiotoxic agents unrelated to the study);
- Patients who already engage in regular and intense physical exercise, as this could interfere with the effects of the intervention.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07640087 · 88362125200005087 · CAAE:88362125200005087