Effects Of Physical Training On Cardiovascular Capacity In Patients Undergoing Chemotherapy For Cancer (Cancer)
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: ANDREA DIAS REIS A Teacher, PhD
- Telefonní číslo: +5598987220570
- E-mail: andrea.dr@ufma.br
Studijní záloha kontaktů
- Jméno: Abia Sousa studanty, Master's student
- Telefonní číslo: +5598984666714
- E-mail: abiiasf@hotmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: Experimental group: will undergo routine monitoring and evaluation, without exercise intervention.
Patients who will not participate in physical exercise programs, but will be monitored under the same clinical and monitoring conditions.
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Experimentální: physical training
patients undergoing chemotherapy treatment who will perform physical exercise.
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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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cardiotoxicity
Časové okno: From registration to the end of treatment in 12 weeks
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The biomarkers used for cardiovascular assessment of cancer patients are: ultrasensitive troponin I or T (marker of myocardial injury).
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From registration to the end of treatment in 12 weeks
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Heart rate variability
Časové okno: From registration to the end of treatment in 12 weeks
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Heart rate variability (HRV) will be measured using a Vantage V3 Polar® heart rate monitor that measures the electrical activity of the heart.
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From registration to the end of treatment in 12 weeks
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Cardiovascular risk in cancer patients.
Časové okno: From registration to the end of treatment in 12 weeks
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Cardiovascular risk will be assessed using the Framingham Scale, which measures the risk of cardiovascular disease in individuals through blood pressure, lipid profile (LDL and HDL), smoking, and diabetes, based on this data, which will be collected from patients' medical records.
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From registration to the end of treatment in 12 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Fatigue
Časové okno: From registration to the end of treatment in 12 weeks
|
Fatigue is a relevant symptom for cancer patients, with a greater impact than in the general population.
It is a symptom described at all stages of the oncology patient's journey, presenting as physical, emotional, or cognitive exhaustion or weakness, which can interfere with daily function and chemotherapy treatment.
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From registration to the end of treatment in 12 weeks
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pain assessment
Časové okno: From registration to the end of treatment in 12 weeks
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Pain assessment will be measured using the Brief Pain Inventory (BPI), a 10-point pain intensity scale. Pain is a primary symptom among cancer patients and cancer survivors. Integrative interventions, such as acupuncture, massage, and music therapy, are effective non-pharmacological approaches for oncological pain with low cost and minimal adverse events |
From registration to the end of treatment in 12 weeks
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Quality of life Global
Časové okno: From registration to the end of treatment in 12 weeks
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The instrument used to assess Quality of life global for cancer will be the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-BR).
The higher scores mean a worse quality of life and lower scores mean a better quality of life.
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From registration to the end of treatment in 12 weeks
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Body Composition
Časové okno: From registration to the end of treatment in 12 weeks
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Body composition will be assessed using bioimpedance.
Cancer leads to metabolic changes that contribute to depletion of nutritional status, resulting in alterations in body composition.
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From registration to the end of treatment in 12 weeks
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functional capacity
Časové okno: From registration to the end of treatment in 12 weeks
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Functional capacity will be assessed by the 6-minute walk test (6MWT) performed in a 10m corridor.
The 6MWT test will measure the total distance covered (meter).
The greater the distance, the better the functional capacity.
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From registration to the end of treatment in 12 weeks
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adherence to physical exercise
Časové okno: From registration to the end of treatment in 12 weeks
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Adherence will be determined through the patients' weekly attendance, and will be monitored by the researcher.
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From registration to the end of treatment in 12 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 88362125200005087
- CAAE:88362125200005087 (Jiný identifikátor: Funded by the researcher)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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