Effects Of Physical Training On Cardiovascular Capacity In Patients Undergoing Chemotherapy For Cancer

ConditionsCardiac Abnormalities Chemotherapeutic Toxicity

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-59

SponsorFederal University of Maranhao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

physical training
Other intervention
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Experimental group: will undergo routine monitoring and evaluation, without exercise intervention.No intervention 0 interventions

Group B: physical trainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Cardiotoxicity

The biomarkers used for cardiovascular assessment of cancer patients are: ultrasensitive troponin I or T (marker of myocardial injury).

Time frame